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CDNA 10-K & 10-Q changes, risk factors and insider trading

CareDx, Inc. · Nasdaq · Services-Medical Laboratories · CIK 1217234 · All filings on SEC.gov

Everything below is quoted or computed from CareDx, Inc.'s public SEC filings. It is not a recommendation to buy or sell. Automated comparisons can contain errors; confirm with the original filing.

At a glance

36 / 17risk-factor paragraphs added / removed in latest 10-K
5new risk-factor headings
0Form 4 filings reporting open-market purchases (last 180 days)
14Form 4 filings reporting open-market sales (last 180 days)

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What changed in the latest 10-K

Comparing 10-K filed 2026-02-25 (period ending 2025-12-31) with 10-K filed 2025-02-28 (period ending 2024-12-31).

Risk Factors (10-K Item 1A)

36new paragraphs
17removed paragraphs
64reworded paragraphs
27,234 → 29,941words in section

New heading “We are incorporating, and may in the future further incorporate, AI technologies into some of our internal processes. These technologies may present business, compliance and reputational risks.”

New heading “Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements.”

New heading “Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.”

New heading “We are subject to changing laws, regulations, standards, and contractual obligations related to privacy, data protection and data security. The actual or perceived failure to comply with such obligations could lead to government enforcement actions, fines, sanctions, private litigation, and/or adverse publicity and could negatively affect our operating results and business.”

New heading “If we fail to maintain an effective system of internal controls, our ability to produce timely and accurate financial statements or comply with applicable regulations could be impaired.”

Removed heading “Our current or future restructuring plans may not optimize costs and simplify our organizational and corporate structure and may materially impair our business operations.”

Removed heading “We face four primary risks relative to protecting critical information: loss of access risk, inappropriate disclosure risk, inappropriate modification risk and the risk of our being unable to identify and audit our controls over the first three risks. In addition, an application, data security or network incident may allow unauthorized access to our systems or data or our customers’ data, disable access to our service, harm our reputation, create additional liability and adversely impact our financial results.”

Removed heading “We have identified a material weakness in our internal control over financial reporting as of December 31, 2022, which was not remediated at December 31, 2024. If we are unable to remediate this material weakness and maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results in a timely manner.”

Removed heading “Our financial controls and procedures may not be sufficient to ensure timely and reliable reporting of financial information, which could materially harm our stock price, exchange listing and our ability to finance our operations.”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

New text topics: litigation, fine, sanction, regulation
“We are subject to changing laws, regulations, standards, and contractual obligations related to privacy, data protection and data security. The actual or perceived failure to comply with such obligations could lead to government enforcement actions, fines, sanctions, private litigation, and/or adverse publicity and could negatively affect our operating results and business.”
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New text topics: cyberattack, breach, ransomware, labor
“We are highly dependent on information technology, or IT, networks and systems for significant elements of our operations, including our laboratory information management system and certain software provided by Epic Systems Corporation. These IT systems support a variety of functions, including laboratory operations, test validation, sample tracking, quality control, customer service support, billing and reimbursement, research and development activities, scientific and medical curation and general administrative activities. …”
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Removed text topics: material weakness, investigation, litigation
“If the steps we take to remediate the material weakness are ineffective, the material weakness could result in material misstatements to our annual or interim consolidated financial statements that might not be prevented or detected on a timely basis, or in delayed filings of our required periodic reports. …”
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New text topics: litigation, breach, china, regulation
“Furthermore, other international jurisdictions, including Singapore, South Korea, China, Brazil, Mexico and Australia, have also implemented laws relating to data privacy and protection. These obligations may be interpreted and applied in a manner that is inconsistent from one jurisdiction to another and may conflict with other requirements or our practices. …”
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New text topics: litigation, fine, sanction, regulation
“•We are subject to changing laws, regulations, standards, and contractual obligations related to privacy, data protection and data security. The actual or perceived failure to comply with such obligations could lead to government enforcement actions, fines, sanctions, private litigation, and/or adverse publicity and could negatively affect our operating results and business.”
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Removed text topics: material weakness
“We have identified a material weakness in our internal control over financial reporting as of December 31, 2022, which was not remediated at December 31, 2024. If we are unable to remediate this material weakness and maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results in a timely manner.”
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Full comparison: every changed paragraph (117)

Green = added, red = removed. Unchanged paragraphs, 6 paragraphs where only numbers/dates changed, and tables are not shown. Read the complete text in the original filing.

Removed

•We have identified a material weakness in our internal control over financial reporting as of December 31, 2022, which was not remediated at December 31, 2024. If we are unable to remediate this material weakness and maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results in a timely manner.

Added

•Security breaches, loss of data, or other disruptions could compromise sensitive information, prevent access to critical information, expose us to liability, and adversely affect our business and our reputation.

Added

•We are subject to changing laws, regulations, standards, and contractual obligations related to privacy, data protection and data security. The actual or perceived failure to comply with such obligations could lead to government enforcement actions, fines, sanctions, private litigation, and/or adverse publicity and could negatively affect our operating results and business.

Removed

•We face four primary risks relative to protecting critical information: loss of access risk, inappropriate disclosure risk, inappropriate modification risk and the risk of our being unable to identify and audit our controls over the first three risks. In addition, an application, data security or network incident may allow unauthorized access to our systems or data or our customers’ data, disable access to our service, harm our reputation, create additional liability and adversely impact our financial results.

Reworded

We have incurred substantial net losses since our inception, and we may continue to incur additional losses for the next several years. For the year ended December 31, 2024,2025, our net incomeloss was $52.5$21.4 millionmillion, and,and for the year ended December 31, 2023,2024, our net lossincome was $190.3$52.5 million. As of December 31, 2024,2025, we had an accumulated deficit of $626.2$735.4 million. We expect to continue to incur significant operating expenses and anticipate that our expenses will increase due to costs relating to, among other things:

Reworded

•researching, developing, validating and commercializing potential new testing services, products and patient and digital solutions, including additional expenses in connection with our continuing development and commercialization of KidneyCare,our HeartCare,testing AlloSeq,services AiTraCand product portfolio, and other future solutions;

Reworded

•employment of operational, financial, accounting and information systems personnel, consistent with expanding our operations and our status as a public company; and

Reworded

For the year ended December 31, 2024,2025, revenue from Medicare for AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare and AlloSure Lung represented 50%46% of testing services revenue. However, we may not be able to maintain or increase our tests reimbursed by Medicare for a variety of reasons, including changes in reimbursement practices, general policy shifts, or reductions in reimbursement amounts. We cannot predict whether Medicare reimbursements will continue at the same payment amount or with the same breadth of coverage in the future, if at all. For example, on December 30, 2024, we received a CPT code for our AlloSure Kidney, AlloSure Heart and AlloSure Lung tests (PLA Code 0540U), which subjects such tests to a repricing process.

Added

On November 25, 2025, CMS issued a final determination to cross-walk AlloSure (0540U) to CPT code 0493U. As a result, PLA Code 0540U was listed on the Clinical Laboratory Fee Schedule effective January 1, 2026 at approximately $2,753. The new reimbursement rate represents an $88 decrease to the previous pricing for our AlloSure Kidney test, and no change to the pricing for AlloSure Heart and AlloSure Lung tests.

Added

On February 3, 2026, the “Consolidated Appropriations Act, 2026” was passed amending the PAMA law. The legislation requires us, and other laboratories, to report private payor rates paid between January 1, 2025 and June 30, 2025 to CMS with a reporting period from May through July 2026. The volume-weighted median of the rates reported for each test would set the Medicare Clinical Laboratory Fee Schedule rate for certain of our tests in calendar years 2027 to 2029. We do not anticipate that the reporting will have a material impact on our current Medicare pricing.

Reworded

On August 10, 2023, MolDX and Noridian released a draft proposed revision to the LCD (DL38568, Palmetto; DL38629, Noridian) that, if adopted, would revise the existing foundational LCD, MolDX: Molecular Testing for Solid Organ Allograft Rejection (L38568 and L38629). On August 16, 2024, CMS issued a press release entitled “MolDX Local Coverage Determination Statement,” announcing that after careful consideration of the feedback received from interested parties, as well as the public comments and further review of evidence, the Medicare Administrative Contractors, or MACs, decided not to finalize the proposed LCD issued on August 10, 2023. CMS further stated that due to the importance of identifying solid organ allograft rejection early and to ensure the public has additional opportunities to comment on the policy, the MACs intend to issue a new LCD in the coming months. CMS stated that neither it nor the MACs have changed coverage for the blood tests that monitor for organ transplantation rejection when ordered by their physicians in medically appropriate circumstances, and explained that transplant patients would continue to have access to these blood tests, including: when there are signs or symptoms of rejection; after a physician-assessed pretest, including for surveillance testing; after an indeterminate biopsy; as a replacement for a biopsy when deemed clinically appropriate by the patient’s qualified physician; and for evaluation of the adequacy of immunosuppression. On July 17, 2025, MolDX and Noridian released a new draft proposed revision to the existing foundational LCD (DL40058, DL40060) with a revised accompanying billing article (DA60146, DA60152), or the Proposed LCD. The Proposed LCD, which underwent public comment, may introduce new coverage criteria, utilization limitations, and a new bundled payment concept for certain CareDx testing, which could lead to lower rates of reimbursement. MolDX and Noridian have 365 days from the date of issuance to finalize the Proposed LCD. We cannot predict the ultimate outcome of the LCD process, including as it relates to the Proposed LCD, and whether it will produce changes in coverage, reimbursement practices, utilization limitations, or payment amounts, any of which could adversely affect our business, operating results and prospects.

Reworded

If future reimbursement price or coverage levels are lesslower than the current price,prices or coverage level, our revenues and our ability to achieve profitability could be impaired, and the market price of our common stock could decline. We may also not be able to maintain or increase the portion of our tests reimbursed by Medicare for a variety of other reasons, including changes in reimbursement practices and general policy shifts.

Reworded

On a five-year rotational basis, Medicare requests bids for its regional MAC services. The MAC for California is currently Noridian Healthcare Solutions. Our current Medicare coverage through Noridian provides for reimbursement for tests performed for qualifying Medicare patients throughout the U.S.United States so long as the tests are performed in our California laboratory. We cannot predict whether Noridian or any future MAC will continue to provide reimbursement for AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare, or AlloSure Lung at the same payment amount or with the same breadth of coverage in the future, if at all. Additional changes in the MAC processing Medicare claims for AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare or AlloSure Lung could impact the coverage or payment amount for our tests and our ability to obtain Medicare coverage for any products we may launch in the future.

Reworded

We expect that sales of testing services and products will account for a substantial portion of our revenue for at least the next two years. If we are unable to increase sales of our testing services or products or successfully develop and commercialize other solutions, tests or enhancements, or if we do not continue our Medicare reimbursement submissions for AlloSure Kidney at the same levels in place prior to the Billing Articles issued by Palmetto MolDX in 2023 (the “Billing Articles”),levels, our revenues and ability to achieve profitability would be impaired, and the market price of our common stock could decline.

Reworded

Third-party payers have in the past disallowed, and may in the future disallow, in whole or in part, requests for reimbursement based on determinations that the member is not eligible for coverage, certain amounts are not reimbursable under plan coverage, were for services provided that were not medically necessary, were redundant or were not coupled with other specified tests or services or additional supporting documentation is necessary. Retroactive adjustments may change amounts realized from third-party payers. For example, we are currently involved in a dispute with a significant Medicare Advantage payer concerning payment of claims. We are seeking recovery of claims amounts that we believe were improperly denied, underpaid or recouped. The payer has also asserted entitlement to recoup additional previously paid claims pursuant to the provisions under the contract. We are also subject to claims reviews and/or audits by suchthird-party payers, including governmental audits of our Medicare claims, and have in the past been required to repay these payers in certain circumstances where a preliminary finding was made that we were incorrectly reimbursed. We may also in the future be required to repay these payers if a finding is made that we were incorrectly reimbursed.

Reworded

Litigation is inherently unpredictable. It is possible that an adverse result in one or more of these possible future events could have a material adverse effect on us, including increased expenses to defend, settle or resolve such litigation. Such matters may cause us to incur costly litigation and/or substantial settlement charges, divert management attention, result in adverse judgments, fines, penalties, injunctions or other relief, and may result in loss of customer or investor confidence regardless of their merit or ultimate outcome.

Reworded

Clinicians and healthcare administrators are traditionally slow to adopt new products, testing practices and clinical treatments, partly because of perceived liability risks and the uncertainty of third-party reimbursement. It is critical to the success of our sales efforts that we continue to educate clinicians, administrators and laboratory directors about our testing services, products and patient and digital solutions, and demonstrate the clinical and diagnostic benefits of these services, products and patient and digital solutions. We believe that clinicians, transplant centers and laboratories may not use our services, products and patient and digital solutions unless they determine, based on published peer-reviewed journal articles, the experience of other clinicians or laboratory verification, that our services, products and patient and digital solutions provide accurate, reliable and cost-effective information that is useful in pre-transplant matching and monitoring their post-transplant recipients. The acceptance of our services, products and patient and digital solutions will depend upon our ability to demonstrate the safety and efficacy, advantages, short and long-term clinical performance and cost-effectiveness of our services, products and patient and digital solutions.

Reworded

Our AlloSure Kidney solution for kidney transplant recipients competes against existing diagnostic tests utilized by pathologists, which involves evaluating biopsy samples to determine the presence or absence of rejection. However, because of the risks and discomforts of the invasive kidney biopsy procedure, as well as the expense and relatively low rate of finding moderate to severe grade rejection, biopsy is not a standard practice for surveillance of transplanted kidneys. Additional competition for kidney surveillance diagnostics currently comes from general, non-specific clinical chemistry tests such as serum creatinine, urine protein, immunosuppression drug levels, donor specific antibodies, complete blood count, lipid profileantibodies and others that are widely ordered by physician offices and routinely performed in clinical reference labs and hospital labs. Our competitors also include companies that are focused on the development and commercialization of molecular diagnostic tests. In the field of post-transplant surveillance, Natera, Eurofins, iMDx, and OncocyteVerici have commercially available molecular diagnostics tests. Other entrants with kitted products have indicated they are entering the market for post-transplant surveillance, including Thermo Fisher, Devyser, Bio-Rad, EuroBio, and Oncocyte.iMDx.

Reworded

Competition for our AlloSure Heart, AlloMap HeartHeart, solutionand HeartCare solutions for heart transplant recipients alsocomes comeslargely from biopsies,biopsies in the first few years, which generally involveinvolves evaluating biopsy samples to determine the presence or absence of rejection. Beyond the first year or two, competition for heart transplant surveillance diagnostics includes echocardiography. Throughout, biopsy and echocardiography are supplemented by general, non-specific clinical chemistry tests such as, immunosuppression drug levels, donor specific antibodies and others that are widely ordered by physician offices and routinely performed in clinical reference labs and hospital labs. This practice has been the standard of care in the United States for many years, and we will need to continue to educate clinicians, transplant recipients and payers about the various benefits of our test in order to change clinical practice. Our competitors also include companies that are focused on the development and commercialization of molecular diagnostic tests. In the field of post-transplant surveillance, Natera and Eurofins has commercially available molecular diagnostics tests.

Added

Competition for our AlloSure Lung solution for lung transplant recipients comes largely from spirometry to assess lung function and biopsy to diagnose rejection in the first few years. These tests are supplemented by general, non-specific clinical chemistry tests such as, immunosuppression drug levels, donor specific antibodies and others that are widely ordered by physician offices and routinely performed in clinical reference labs and hospital labs. This practice has been the standard of care in the United States for many years, and we will need to continue to educate clinicians, transplant recipients and payers about the various benefits of our test in order to change clinical practice. Our competitors also include companies that are focused on the development and commercialization of molecular diagnostic tests. In the field of post-transplant surveillance, Natera, has commercially available molecular diagnostics tests.

Reworded

Competition for our patient and digital solutions includeincludes various companies that develop application software and operate in the healthcare field. Our competition for patient solutions includes hospital-affiliated pharmacies located on-site at the transplant center and specialty pharmacies that provide transplant-specific care and dispensing services. Our primary competitor for our patient management EMR solution is Phoenix, Epic's transplant application. In addition, other established and emerging healthcare, information technology and service companies may commercialize competitive products including informatics, analysis, integrated genetic tools and services for health and wellness.

Reworded

Our clinical development relies on our ability to secure access to tissue and blood samples, as well as recipient information, including biopsy results and clinical outcomes from the same patient. Furthermore, the studies through which our future solutions are developed may rely on access to multiple samples from the same recipient over a period of time as opposed to samples at a single point in time or archived samples. We will require additional samples and recipient data for future research, development and validation. Access to recipients and samples on a real-time, or non-archived, basis is limited and often on an exclusive basis, and there is no guarantee that future initiatives will be successful in obtaining and validating additional samples. Additionally, the process of negotiating access to new and archived donor and recipient data and samples is lengthy since it typically involves numerous parties and approval levels to resolve complex issues, such as usage rights, institutional review board approval, recipient consent, privacy rights and informed consent of recipients, publication rights, intellectual property ownership and research parameters. If we are not able to acquire or negotiate access to new and archived donor and recipient data and tissue and blood samples with source institutions, or if other laboratories or our competitors secure access to these samples before us, our ability to research, develop and commercialize future solutions such as AlloSure Kidney will be limited or delayed.

Reworded

The value of AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare and AlloSure Lung depends, in large part, on our ability to perform AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare and AlloSure Lung tests on a timely basis and at a high quality standard, and on our reputation for such timeliness and quality. Failure to implement necessary procedures, transition to new equipment or processes or hire new personnel could result in higher costs of processing or an inability to meet market demand in a timely manner. In addition, changes in the funding of the FDA or other government agencies or comparable foreign regulatory authorities could hinder, prevent or delay their regulatory review and approval processes or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely.

Reworded

If our laboratory facility in the U.S.United States becomes inoperable, we will be unable to perform AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare, AlloSure Lung and future testing solutions, if any, and our business will be harmed.

Reworded

We perform all of our testing services for the U.S.United States in our laboratory located in Brisbane, California. We do not have redundant laboratory facilities. Brisbane, California is situated on or near earthquake fault lines. Our facility and the equipment we use to perform testing services would be costly to replace and could require substantial lead time to repair or replace if damaged or destroyed. Our facilities may be harmed or rendered inoperable by natural or man-made disasters, including earthquakes, power outages, wildfires, flooding, hurricanes, droughts and other extreme weather events and changing weather patterns, which are increasing in frequency due to the impacts of climate change and may render it difficult or impossible for us to perform our tests for some period of time. The inability to perform our tests may result in the loss of customers or harm our reputation, and we may be unable to regain those customers in the future. Although we possess insurance for damage to our property and the disruption of our business, we do not have earthquake insurance and thus coverage may not be sufficient to cover all of our potential losses and may not continue to be available to us on acceptable terms, if at all. We do not know, however, if we will be able to maintain existing insurance with adequate levels of coverage, and, in the event of a major earthquake in our region, our business could suffer significant and uninsured damage and loss.

Reworded

In order to establish a redundant laboratory facility, we would have to spend considerable time and money securing adequate space, constructing the facility, recruiting and training employees and establishing the additional operational and administrative infrastructure necessary to support a second facility. Additionally, any new clinical laboratory facility opened by us in the U.S.United States would be required to be certified under the Clinical Laboratory Improvement Amendments of 1988, or CLIA, a federal law that regulates clinical laboratories that perform testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention or treatment of disease. We would also be required to secure and maintain state licenses required by several states, including California, Florida, Maryland, New York, Rhode Island and Pennsylvania, which can take a significant amount of time and result in delays in our ability to begin operations at that facility.

Reworded

There is an increasing focus from certain investors, employees, regulators and other stakeholders concerning corporate responsibility, specifically related to environmental, social and governance, or ESG, factors. Some investors and investor advocacy groups may use these factors to guide investment strategies and, in some cases, investors may choose not to invest in our company if they believe our policies relating to corporate responsibility are inadequate. Third-party providers of corporate responsibility ratings and reports on companies have increased to meet growing investor demand for measurement of corporate responsibility performance, and a variety of organizations currently measure the performance of companies on such ESG topics, and the results of these assessments are widely publicized. Investors, particularly institutional investors, use these ratings to benchmark companies against their peers and if we are perceived as lagging with respect to ESG initiatives, these investors may engage with us to improve ESG disclosures or performance and may also make voting decisions, or take other actions, to hold us and our Board of Directors accountable. In addition, the criteria by which our corporate responsibility practices are assessed may change, which could result in greater expectations of us and cause us to undertake costly initiatives to satisfy such new criteria. If we elect not to or are unable to satisfy such new criteria, investors may conclude that our policies with respect to corporate responsibility are inadequate. We may face reputational damage in the event that our corporate responsibility procedures or standards do not meet the standards set by various constituencies. At the same time, an increasing number of stakeholders, regulators and lawmakers have expressed or pursued contrary views, including the proposal or enactment of “anti-ESG” policies, legislation, executive orders or initiatives or issued related legal opinions. Conflicting regulations and a lack of harmonization of ESG legal and regulatory environments across the jurisdictions in which we operate may create enhanced compliance risks and costs.

Added

Further, we have in the past and may continue to communicate certain initiatives, including goals, regarding environmental matters, responsible sourcing, and social investments. We could fail, or be perceived to fail, in our achievement of such initiatives or goals, or we could fail in fully and accurately reporting our progress on such initiatives and goals. In addition, we could be criticized for the scope of such initiatives or goals or perceived as not acting responsibly in connection with these matters.

Reworded

Ongoing focus on corporate responsibility matters by investors, stockholders, lawmakers, listing exchanges or other constituencies may impose additional costs or expose us to new risks. Any failure or perceived failure by us in this regard could have a material adverse effect on our reputation and on our business, share price, financial condition or results of operations, including the sustainability of our business over time. In addition, in March 2024, the SEC adopted rules that, among other matters, establish a framework for reporting of climate-related risks. However, the SEC voluntarily stayed implementation of the final rules pending completion of judicial review. To the extent the proposed rules survive ongoing and possibly additional forthcoming legal challenges, they may impose additional reporting obligations, and we could incur increased costs.

Added

If we are not effective in addressing ESG matters affecting our business, or setting and meeting relevant ESG goals, our reputation and financial results may suffer.

Reworded

We rely on third-party laboratory services providers to draw and partially process the patient blood samples that are analyzed in our Brisbane, California laboratory. Our business will suffer if these service providers do not support AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare, AlloSure Lung or the otherfuture solutions that we may develop. For example, these laboratories may determine that processing the samples for our solutions requires too much additional effort. Additionally, if transplant facilities have relationships with large reference laboratories that will not process and send out our specimens, the clinicians at these facilities may deem ordering our tests outside of these relationships too inconvenient for their patients. A lack of acceptance of our current and future solutions by these service providers could result in lower test volume.

Reworded

•fund our clinical validation study activities;

Reworded

•sustain or achieve broader commercialization of AlloSureour Kidney,testing KidneyCare, AlloMap Heart, AlloSure Heart, HeartCare, AlloSure Lung,services, our products and patient and digital solutions or enhancements to those tests, products and patient and digital solutions;

Reworded

Additional capital, if needed, may not be available on satisfactory terms, or at all, and might include the issuance of equity securities, debt, cash from collaboration agreements or a combination of these. In addition, rules and regulations of the SEC may restrict our ability to conduct certain types of financing activities or may affect the timing of and the amounts we can raise by undertaking such activities. Furthermore, if we raise additional funds by issuing equity securities, dilution to our existing stockholders could result. Any equity securities issued also may provide for rights, preferences or privileges senior to those of holders of our common stock and would result in dilution to our stockholders. If we raise additional funds by issuing debt securities, these debt securities would have rights, preferences and privileges senior to those of holders of our common stock, and the terms of the debt securities issued could impose significant restrictions on our operations. If we raise additional funds through collaborations and licensing arrangements, we might be required to relinquish significant rights to our technologies or our solutions under development, or grant licenses on terms that are not favorable to us, which could lower the economic value of those programs to us. If we cannot raise funds on acceptable terms, we may not be able to develop or enhance our products, execute our business plan, take advantage of future opportunities, or respond to competitive pressures or unanticipated customer requirements. If adequate funds are not available, we may have to scale back our operations or limit our research and development activities, which may cause us to grow at a slower pace, or not at all, and our business could be adversely affected.

Added

We have experienced changes in our executive leadership and we may experience further changes in executive leadership in the future. Changes to strategic or operating goals, which can often times occur with the appointment of new executives, can create uncertainty, may negatively impact our ability to execute quickly and effectively, and may ultimately be unsuccessful. If we do not integrate new executives successfully, we may be unable to manage and grow our business, and our financial condition and profitability may suffer as a result. If we are unable to attract and retain qualified management personnel, our business could suffer.

Reworded

As part of our longer-term growth strategy, we intend to target select international markets to grow our presence outside of the U.S.United States. We also currently distribute products in Europe, Canada, Asia, the Middle East, and Central and South America. To promote the growth of our business internationally, we will need to attract additional partners to expand into new markets.

Reworded

If our present or future partners do not perform adequately, or we are unable to enter into agreements in new markets, we may be unable to achieve revenue growth or market acceptance in jurisdictions in which we depend on partners. In addition, conducting international operations subjects us to risks that, generally, we have not faced in the U.S.,United States, including:

Reworded

•risks related to our operations in Russia and Iran, including restrictions on our access to banking services, changes in the U.S.,United States, EU or other sanctions laws that limit financial transactions or increase or compliance burden and potential legal exposure and counterparty risk;

Reworded

•political and economic instability, including interruptions in international relations, wars, terrorism and political unrest, general security concerns, outbreak of disease, boycotts, curtailment of trade and other business restrictions, including the ongoing conflict between Ukraine and Russia, the global impact of restrictions and sanctions imposed on RussiaRussia, tariffs imposed on global trade and the Israel-Hamasongoing warconflicts in the Middle East;

Added

The occurrence of any one of the above could harm our business and, consequently, our revenues and results of operations. Our expanding international operations could be affected by changes in laws, trade regulations and tariffs, labor and employment regulations, and procedures and actions affecting approval, production, pricing, reimbursement and marketing of our current and future products and solutions, as well as by inter-governmental disputes. As of the date of the Annual Report on Form 10-K, certain trade restrictions and tariffs on imports from Canada, China, and Mexico have been implemented, as well as retaliatory tariffs enacted in response to such actions. In light of these events, there continues to exist significant uncertainty about the future relationship between the United States and other countries with respect to such trade policies, treaties, and tariffs. These developments, or the perception that any of them could occur, may have a material adverse effect on global economic conditions and the stability of global financial markets, and may significantly reduce global trade and, in particular, trade between the impacted nations and the United States. Any of these factors could depress economic activity and restrict our access to potential partners, suppliers or other third parties we seek to do business with and, in turn, have a material adverse effect on the business and financial condition of such third parties, which in turn would negatively impact us.

Removed

The occurrence of any one of the above could harm our business and, consequently, our revenues and results of operations. Our expanding international operations could be affected by changes in laws, trade regulations, labor and employment regulations, and procedures and actions affecting approval, production, pricing, reimbursement and marketing of our current and future products and solutions, as well as by inter-governmental disputes.

Added

We are incorporating, and may in the future further incorporate, AI technologies into some of our internal processes. These technologies may present business, compliance and reputational risks.

Added

We currently use artificial intelligence, or AI, in certain of our internal processes to increase employee efficiency and productivity and to optimize software and algorithm development process, and we may decide to expand our use of AI in the future. As with many new and emerging technologies, AI presents numerous risks and challenges that could adversely affect our business. If we fail to keep pace with rapidly evolving AI technological developments, especially in the healthcare sector, our competitive position and business results may suffer. Additionally, our competitors and other third parties may incorporate AI into their operations and processes more quickly or more successfully than us, which could impair our ability to compete effectively and adversely affect our results of operations.

Added

At the same time, use of AI has recently become the subject of significant media attention and political debate. While we do not currently use AI in any of our products, the introduction and use of AI technologies, particularly generative AI, into new or existing offerings may result in new or expanded risks and liabilities, including enhanced governmental or regulatory scrutiny, litigation, compliance issues, ethical concerns, confidentiality or security risks, as well as other factors that could adversely affect our reputation, our business, operating results and financial condition. For example, AI technologies can generate content that is, or is alleged to be, factually inaccurate, deficient, misleading, or otherwise flawed, or that results in unintended biases and discriminatory outcomes, which could negatively impact our customers and affect our product offerings, harm our reputation and business, and expose us to liability. Laws, regulations or industry standards that develop in response to the use of AI may be burdensome or may restrict our ability to use, develop or deploy AI, particularly generative AI technologies, in our products or processes to the extent we may choose to do so in the future, or our efforts to expand our business. Legislation governing the development and use of AI has been passed or is under consideration in the U.S. at the federal, state and local level, as well as internationally, including the EU AI Act.

Added

We use AI technologies from third parties, which may include licensed and open source software. If we are unable to maintain rights to use these AI technologies on commercially reasonable terms, we may be forced to acquire or develop alternative AI technologies, which may limit or delay our ability to provide competitive offerings and may increase our costs. These AI technologies also may incorporate data from third-party sources, which may expose us to risks associated with data rights and protection. The legal and regulatory landscape surrounding AI technologies is rapidly evolving and uncertain, including with respect to intellectual property ownership and license rights, cybersecurity, and data protection laws, among others, and has not yet been fully addressed by courts or regulators. The evolving legal, regulatory, and compliance framework for AI technologies may also impact our ability to protect our own data and intellectual property against infringing use.

Added

Many of the countries in which we operate, including the U.S. and several of the members of the European Union, have experienced and continue to experience uncertain economic conditions resulting from global as well as local factors.

Reworded

Many of the countries in which we operate, including the U.S. and several of the members of the European Union, or EU, have experienced and continue to experience uncertain economic conditions resulting from global as well as local factors. Our business or financial results may be adversely impacted by these uncertain economic conditions, including: adverse changes in interest rates, foreign currency exchange rates, tax laws or tax rates; prolongedthe periodsimposition of trade barriers such as tariffs (and judicial uncertainty about their enforceability), quotas, trade wars, preferential bidding or import or export licensing requirements; increased inflation globally and in the U.S. in particular; liquidity concerns at financial institutions; a potential economic recession; contraction in the availability of credit in the marketplace due to legislation or other economic conditions, which may potentially impair our ability to access the capital markets on terms acceptable to us or at all; and the effects of government initiatives to manage economic conditions. Moreover, disagreement over the federal budget has caused the U.S. federal government to shut down for periods of time. Continued adverse political conditions or a severe or prolonged economic downturn, such as the global financial crisis, could result in a variety of risks to our business, including a decrease in the demand for our tests and in our ability to raise additional capital when needed on acceptable terms, if at all. If elevated levels of inflation were to persist or if the rate of inflation were to accelerate, the purchasing power of our cash and cash equivalents may be further diminished, our expenses could increase faster than anticipated or payers may be unwilling or unable to increase reimbursement rates to compensate for inflationary impacts, and we may utilize our capital resources sooner than expected. In addition, we cannot predict how future economic conditions will affect our critical customers, suppliers and distributors and any negative impact on our critical customers, suppliers or distributors may also have an adverse impact on our results of operations or financial condition. We cannot anticipate all of the ways in which the foregoing, and the current economic climate and financial market conditions generally, could adversely impact our business.

Reworded

We are subject to income taxes in the United States and various foreign jurisdictions. Our effective tax rate may be lower or higher than experienced in the past due to numerous factors, including a change in the mix of our profitability from country to country, the establishment or release of valuation allowances against our deferred tax assets, and changes in tax laws. In addition, we have recorded gross unrecognized tax benefits in our financial statements that, if recognized, would impact our effective tax rate. We are subject to tax audits in various jurisdictions, including the United States, and tax authorities may disagree with certain positions we have taken and assess additional taxes. There can be no assurance that we will accurately predict the outcomes of these audits, and the actual outcomes could have a material impact on our net income or financial condition. Any of these factors could cause us to experience an effective tax rate significantly different from previous periods or our current expectations, which could have an adverse effect on our business and results of operations. The recognition of deferred tax assets is reduced by a valuation allowance if it is more likely than not that the tax benefits will not be realized. We regularly review our deferred tax assets for recoverability and establish a valuation allowance based on historical income, projected future income, the expected timing of the reversals of existing temporary differences, and the implementation of tax-planning strategies.

Added

Additionally, the U.S. Congress recently enacted the One Big Beautiful Bill Act, or the OBBBA, which includes significant provisions, including tax cut extensions and modifications to the international tax framework, and the restoration of the immediate deductibility of domestic research and development expenditures beginning with our 2025 taxable year.

Removed

Our current or future restructuring plans may not optimize costs and simplify our organizational and corporate structure and may materially impair our business operations.

Removed

We have previously announced restructuring plans intended to optimize costs and simplify our organizational and corporate structure, and we most recently implemented such plans in January, May and December 2023, and November and December 2024. Any additional restructuring efforts may divert management’s attention, increase expenses on a short-term basis and lead to potential issues with employees, customers or suppliers. If we do not complete these activities in a timely manner; do not realize anticipated cost savings, synergies and efficiencies or business disruption occurs during or following such activities; or incur unanticipated charges, our business, financial condition, operating results and cash flows may be materially impaired.

Reworded

As part of our business strategy, we may pursue acquisitions of complementary businesses and assets, as well as technology licensing arrangements to expand our existing know-how, expertise and intellectual property in other fields, including for the development of other commercial tests. We also may pursue strategic alliances that leverage our core technology and industry experience to expand our test offerings or distribution. We may not be able to successfully complete any acquisitions or successfully integrate any acquired business. Our ability to successfully grow through acquisitions depends upon our ability to identify, negotiate, complete and integrate suitable acquisition targets. The identification of suitable acquisition candidates can be difficult, time-consuming and costly, and we may not successfully complete acquisitions that we target in the future. Risks we may face in connection with acquisitions include:

Reworded

We may not be able to achieve the anticipated strategic benefits from our acquisition of Ottr, XynManagement, TransChart, MedActionPlan, TTP, HLA Data Systems, MediGO, or any other businesses or assets that we may acquire.

Reworded

The integration of any businesses or assets we may acquire will be a time-consuming process. The integration process will require substantial management time and attention, which may divert attention and resources from other important areas, including our existing business. In addition, we may not be able to fully realize the anticipated strategic benefits of any such combination or integration and any other businesses or assets we have or may acquire, which includes, with respect to Ottr, the complementary Ottr software, with respect to XynManagement, XynQAPI, TransChart and MedActionPlan, as well as TTP, and HLA Data Systems, and MediGO'sSystems' services and technologies, and in each case the benefits of any significant cross-selling opportunities. If we are not able to achieve the anticipated strategic benefits of any such combination, it could adversely affect our business, financial condition and results of operations, and could adversely affect the market price of our common stock if the anticipated financial and strategic benefits of the acquisition are not realized as rapidly as, or to the extent anticipated by investors and analysts. Failure to achieve these anticipated benefits could result in increased costs and decreases in future revenue and/or net income following the acquisition.

Reworded

Additionally, from time to time, payers change processes that may affect timely payment. For example, some commercial payers have instituted prior authorization requirements before our testing is performed. These changes may result in uneven cash flow or impact the timing of revenue recognized withfrom these payers. With respect to payments received from governmental programs, factors such as a prolonged government shutdown could cause significant regulatory delays or could result in attempts to reduce payments made to us by federal government healthcare programs. In addition, payers may refuse to ultimately make payment if their processes and requirements have not been met on a timely basis. In addition, we are subject to and expect to continue to be subject to one or more audits under the CMS Recovery Audit Contractor, or RAC, program, the CMS Targeted Probe and Educate, or TPE, program, the Unified Program Integrity Contractors, or UPIC, program and other federal and state audits. Following two rounds of TPE audit in 2022 in which AlloSure Kidney and AlloSure Heart claims were reviewed and denied, Noridian informed us in the first quarter of 2023 it was making a referral to CMS given disagreement as to the interpretation of the applicable LCDs. We appealed claims which had a basis for appeal. Ultimately, 100% of claims which were appealed were resolved in our favor. We have also met with CMS to discuss the difference in interpretation and intend to continue this dialogue regarding our position that the Noridian interpretation is inconsistent with the LCD, MolDX’s and Noridian’s prior associated responses to public comments, and medical necessity. In addition, in the second quarter of 2023, we received a record request from UPIC. UPIC has the authority to implement Medicare payment suspensions during the pendency of an audit and the ability to refer billing matters to other regulatory agencies. In the third quarter of 2023, the UPIC provided us with notice that we had received Medicare payments in error, resulting in an overpayment of $38,975.02. The UPIC further stated that going forward it wished to support our efforts to remedy the billing issues and it would continue to monitor our Medicare claim submission patterns. We have appealed the deniedFour claims consistent with our statutory rights. In the first quarter of 2025, we received an additional UPIC records request. We expect further intensification of the regulatory environment surrounding the healthcare industry, as third-party firms engaged by CMS and others conduct extensive pre- and post-payment audits of claims data as well as medical and other records in order to identify improper payments to healthcare providers under the Medicare and Medicaid programs. We could be forced to expend considerable resources responding to these audits or other inquiries. These billing complexities, and the resulting uncertainty in obtaining payment for AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare and AlloSure Lung and future solutions, as well as the results of Noridian’s referral to CMS and any audits or inquiries evaluating our services create a risk of further regulatory or enforcement action from these or other regulatory agencies, or that our claims are denied or that any historical reimbursement of such claims isremain subject to forfeitureappeal andwith couldthe negativelyrest affectbeing resolved in our revenue, cash flows and profitability.favor.

Added

In the first quarter of 2025, we received a second UPIC records request with which we complied. In the second quarter of 2025, the UPIC notified us that it had received the medical records we provided in connection with such request and concluded that no further information was necessary at that time. The UPIC identified no overpayment in connection with the second request and thanked us for our cooperation.

Reworded

The pricing and reimbursement environment may change in the future and become more challenging as a result of any of several possible regulatory developments, including policies advanced by the U.S. government, new healthcare legislation or fiscal challenges faced by government health administration authorities. Specifically, there have been a number of legislative and regulatory proposals and initiatives to change the healthcare system in ways that could affect our ability to profitably sell any diagnostic products we may develop and commercialize. Some of these proposed and implemented reforms could result in reduced reimbursement rates for our diagnostic products from governmental agencies or other third-party payers, which would adversely affect our business strategy, operations and financial results. For example, as a result of the Patient Protection and Affordable Care Act of 2010 (as amended by the Health Care and Education Reconciliation Act of 2010), or collectively, the Affordable Care Act, substantial changes have been made and may continue to be made to the current system for paying for healthcare in the U.S.,United States, including changes made in order to extend medical benefits to those who currently lack insurance coverage. The Affordable Care Act also provided that payments under the Medicare CLFS were to receive a negative 1.75% annual adjustment through 2015. Although we have not been subject to such adjustment in the past, we cannot be certain that the claims administrators will not attempt to apply this adjustment in the future.

Reworded

There have been public announcements by President Trump and members of the U.S. Congress regarding plans to repeal and replace the Affordable Care Act. We cannot predict the ultimate form or timing of any repeal, replacement or expansion of the Affordable Care Act or the effect such repeal, replacement or expansion would have on our business. Regardless of the impact of any repeal, replacement or expansion of the Affordable Care Act on us, the government has shown significant interest in pursuing healthcare reform and reducing healthcare costs. Any government-adopted reform measures could decrease the amount of reimbursement available from governmental and other third-party payers. On April 1, 2013, cuts to the federal budget resulting from sequestration were implemented, requiring a 2% cut in Medicare payment for all services, including AlloSure Kidney and AlloMap Heart, and is expected to remain in effect through at least 2025.2032. The OBBBA, which was recently signed into law, reduces funding to federal healthcare programs and imposes additional requirements to be eligible for healthcare, which may result in decreased access to healthcare, particularly for Medicaid programs. Federal budgetary limitations and changes in healthcare policy, such as the creation of broad limits for diagnostic products or requirements that Medicare patients pay for portions of clinical laboratory tests or services received, could substantially diminish the sale, or inhibit the utilization, of AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare and AlloSure Lung and our future diagnostic solutions, increase costs, divert management’s attention and adversely affect our ability to generate revenue and achieve profitability.

Reworded

In addition to the Affordable Care Act,Act and the OBBBA, there will continue to be proposals by legislators at both the federal and state levels, regulators and third-party payers to reduce costs while expanding individual healthcare benefits. Certain of these changes could impose additional limitations on the prices we will be able to charge for our current and future solutions or the amounts of reimbursement available for our current and future solutions from governmental agencies or third-party payers.

Added

Further, the current federal administration has announced that it is looking for opportunities to improve efficiency and identify fraud and ineffective use of resources at government agencies. This includes government agencies we may interact with like the CMS, the HHS, and the FDA. There is a possibility that changes will be made at the CMS, the HHS, the FDA and other governmental agencies that we may interact with and that these changes could have a material adverse impact on our business.

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Management's Discussion & Analysis (MD&A) (10-K Item 7)

22new paragraphs
16removed paragraphs
36reworded paragraphs
5,632 → 5,766words in section

New heading “Full Year 2025 Financial Highlights”

Removed heading “Full Year 2024 Financial Highlights”

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Reworded topics: litigation, impairment, write-down

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Net cash usedprovided inby operating activities for the year ended December 31, 20232024 was $18.4$38.0 million. Net operating assets decreased by $102.3 million. Our netnoncash loss of $190.3 million was our primary use of cash in operating activities. Our net loss alsoitems included the following noncash items: $49.1$66.4 million in stock-based compensation expense, $14.4$14.2 million of depreciation and amortization expense, $5.6 million of amortization of right-of-use assetsassets, $0.6 million of $5.4 million, asset impairments and write-downs of $1.0 million, amortization of premium on short-term marketable securities, net of $4.9 million, gain on settlement of obligation and recovery of written-off investment of $2.1 millionsecurities and revaluation of contingent consideration to estimated fair value of $2.7$0.9 million. Cash used in operating activities was also due to an increase in accounts receivable of $16.0 million. Cash used in operating activities was partially offset by an increase in net operating assets of $90.6 million including litigation expense of $96.3 million recorded as other liabilities related to the jury award in the Natera IP infringement matter.
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New text topics: litigation, lawsuit, class action
“The change in litigation settlement expense was mainly due reversal of litigation expense in 2024 related to the favorable outcome of patent infringement claims filed by Natera against us where the District Court ruled that the patents asserted against us were invalid, which was partially offset by settlement of the Securities Class Action lawsuit during 2025. …”
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Reworded topics: impairment, goodwill

Paragraph as it now reads, with added and removed wording marked:

Our annual impairment test date is December 1st. During the goodwill impairment review, we assess qualitative factors to determine whether it is more likely than not that the fair value of the reporting unit is less than the carrying amount, including goodwill. The qualitative factors include, but are not limited to, macroeconomic conditions, industry and the market considerations, and our overall financial performance. If, after assessing the totality of these qualitative factors, we determine that it is not more likely than not that the fair value of the reporting unit is less than the carrying amount, then no additional assessment is deemed necessary. Otherwise, we proceed to compare the estimated fair value of the reporting unit with the carrying value, including goodwill. If the carrying amount of the reporting unit exceeds the fair value, we record an impairment loss based on the difference. We elect to bypass the qualitative assessment in a period and proceeds to perform the quantitative goodwill impairment test.
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Removed text
“Full Year 2024 Financial Highlights”
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New text
“Full Year 2025 Financial Highlights”
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Reworded topics: impairment

Paragraph as it now reads, with added and removed wording marked:

SalesGeneral and marketingadministrative expenses decreased by $1.6$17.6 million, or (2)%,14%, for the year ended December 31, 2024,2025, compared to the year ended December 31, 2023,2024. The decrease was primarily dueattributable to adecreases decreaseof $25.7 million in stock-based compensation expense and $2.4 million in legal and consulting expenses, partially offset by increases of $1.4$3.7 million,million in software-related costs, $2.9 million in personnel-related costs, $2.3 million in a decreaseone-time impairment charge related to an intangible asset and associated construction in progress, $1.0 million in equipment related expenses and $0.6 million in travel costs of $0.6 million and a decrease in tradeshows and events of $1.6 million, offset by an increase in personnel-related costs of $2.2 million.expenses.
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Green = added, red = removed. Unchanged paragraphs, 8 paragraphs where only numbers/dates changed, and tables are not shown. Read the complete text in the original filing.

Reworded

We are a leading precision medicine company focuseddedicated onto theimproving discovery, development and commercialization of clinically differentiated, high-value diagnostic solutionsoutcomes for transplant patients and caregivers.advancing organ health. We offerdeliver solutions designed to empower clinicians and improve patient outcomes. Our integrated solutions include non-invasive molecular testing services,for products,heart, kidney, and lung transplants; laboratory products; digital health technologies; and patient and digital solutions alongthat thesupport pre-care before and post-transplantafter patienttransplant. journey,CareDx andis we are athe leading provider of genomics-based information for transplant patients.

Reworded

Our commercially available post-transplant testing services consist of AlloSure® Kidney, a donor-derived cell-free DNA, or dd-cfDNA, solution for kidney transplant patients, AlloMap® Heart, a gene expression profiling solution for heart transplant patients, AlloSure® Heart, a dd-cfDNA solution for heart transplant patients, HeartCare, the combined use of AlloMap Heart and AlloSure Heart, and AlloSure® Lung, a dd-cfDNA solution for lung transplant patients. We have initiated several clinical studies to generate data on our existing and planned future testing services. WeFrom havetime signedto multipletime, we partner with pharma and biopharma researchcompanies partnershipsto foruse AlloCell,our a surveillance solution that monitors the level of engraftmenttechnology and persistencetests, ofoften allogeneicin cellsclinical trials, to identify or screen for patients whothat havemay receivedbe cellappropriate therapy.candidates for their products. We also offer high-quality products in the pre-transplant space that increase the chance of successful transplants by facilitating a better match between a donor and a recipient of stem cells and organs. We also provide digital solutions to transplant centerssolutions and various offerings inthat help transplant centers with patient management, outcomes quality and digitaloperational solutions.support.

Removed

•Sixth consecutive quarter of sequential testing services volume growth

Removed

•AlloSure® Kidney surveillance testing continued to increase in the fourth quarter

Removed

•Submitted first manuscript of the Kidney Outcomes Allograft Rejection (KOAR) study for publication

Removed

•Published study in the journal Transplant International shows AlloSeq cfDNA highly accurate in detecting organ transplant rejection

Removed

Full Year 2024 Financial Highlights

Reworded

•Revenue of $333.8$108 million, drivenan by testing services revenue growthincrease of 19%25% year-over-year

Reworded

•Testing services revenue of $249.4$78 million, increasedan 19%increase of 23% year-over-year, and testing services volume of approximately 176,000,53,000, increasedan 6%increase of 17% year-over-year

Added

•Average revenue per test of approximately $1,480 including approximately $5 million in prior period revenue

Added

•Net loss of $4 million, compared to net income of $88 million for the fourth quarter of 2024

Removed

•GAAP net income of $52.5 million

Added

•Share repurchases of $12 million during the quarter of 773,000 shares at an average price of $15.79 per share

Added

Full Year 2025 Financial Highlights

Added

•Revenue of $380 million, an increase of 14% year-over-year

Added

•Testing services revenue of $275 million, an increase of 10% year-over-year, and testing services volume of approximately 200,000, an increase of 14% year-over-year

Added

•Patient and digital solutions revenue of $57 million and product revenue of $48 million, representing year-over-year growth of 31% and 19%, respectively

Added

•Net loss of $21 million

Added

•Cash flow from operations of $42 million

Reworded

•Cash, cash equivalents,equivalents and marketable securities of $261approximately million,$200 with no debt,million as of December 31, 20242025

Added

•Share repurchases of $88 million during the year of 5.8 million shares at an average price of $15.16 per share

Reworded

The growth of our patient and digital revenues is tied to the continued successful implementation of our pharmacy solutions, Ottr, MedActionPlan and XynQAPI software businesses, as well as continued support and maintenance of existing pharmacy, MedActionPlan, Ottr and XynManagement customers. The Ottr software, TransChart, Tx Access and XynQAPI are currently implemented in multiple locations in the U.S.United States. The Ottr software implementation and XynQAPI implementation and support teams are based in Omaha, Nebraska. In addition, patient solutions offered by TTP in Flowood, Mississippi include hospital-affiliated pharmacies located on-site at the transplant center and specialty pharmacies that provide transplant-specific care and dispensing services. WithAdditionally, the additionwith of HLA Data Systems, we are now able to support HLA laboratories in managing their day-to-day workflow. With the addition of MediGO, we are now serving the organ procurement market for organ logistical needs.

Reworded

Our spending on research and development may vary substantially from quarter to quarter. We conduct clinical studies to validate our new products, as well as on-goingongoing clinical and outcome studies to further the published evidence to support our commercialized tests. Spending on research and development for both experiments and studies may vary significantly by quarter depending on the timing of these various expenses.

Reworded

Testing services revenue increased by $39.7$25.1 million, or 19%,10%, for the year ended December 31, 2024,2025, compared to the year ended December 31, 2023.2024. RevenueThe increase iswas primarily driven by testing services volume growth of 6%,approximately 14% as compared to the year ended December 31, 2024. This increase was partially offset by an increase in the refunds reserve of $3.5 million, and improveda averagedecrease sellingof price$7.8 drivenmillion by increasedin collections includingduring collectionsthe year ended December 31, 2025, as compared to the year ended December 31, 2024, under ASC 606 related to specific tests performed in prior periods.

Reworded

Product revenue increased by $7.3$7.6 million, or 22%,19%, for the year ended December 31, 2024,2025, compared to the year ended December 31, 2023,2024. The increase was primarily due to higher demandsales of our commercial NGS-based kitted solutions.solutions resulting from growth in our existing business including conversions of targeted customers.

Removed

Patient and digital solutions revenue

Reworded

Patient and digital solutions revenue increased by $6.5$13.3 million, or 18%,31%, during the year ended December 31, 2024,2025, compared to the year ended December 31, 2023,2024. The increase was primarily duedriven toby revenuehigher generatedpharmacy sales and growth in our digital solutions, particularly an expanded customer base from HLAOttr Data Systems, MediGO, Transplant Pharmacy and other core digital offerings.software.

Reworded

Cost of testing services decreasedincreased by $2.0$6.4 million, or (4)%,12%, for the year ended December 31, 2024,2025, compared to the year ended December 31, 2023.2024. The decreaseincrease iswas primarily drivenattributed to higher testing services volume, partially offset by the continuous efficiency measures to lower laboratory expenses.

Reworded

Cost of product increaseddecreased by $5.0$0.4 million, or 27%,2%, for the year ended December 31, 2024,2025, compared to the year ended December 31, 2023,2024. The decrease was primarily due to certain cost reduction efforts offset by an increaseincreased insales productof revenue.our commercial NGS-based kitted solutions.

Reworded

Cost of patient and digital solutions increased by $4.7$7.5 million, or 18%,25%, for the year ended December 31, 2024,2025, compared to the year ended December 31, 2023.2024. The increase in the cost of patient and digital solutions is in line with the increase in revenue for patient and digital solutions and iswas primarily due to an increase in the cost of goods from sales in theour pharmacy business andresulting ourfrom digitalhigher offerings.sales.

Reworded

Research and development expenses decreased by $9.5$1.1 million, or (12)%,1%, for the year ended December 31, 2024,2025, compared to the year ended December 31, 2023,2024. The decrease was primarily dueattributable to adecreases decreaseof $4.7 million in clinical trialstrial ofexpenses, $6.5$2.0 million, a decreasemillion in consulting and professionallicensing feesexpense and $1.5 million in stock-based compensation expense, partially offset by increases of $2.4$5.5 million in personnel-related costs and a$1.6 decreasemillion in softwaresoftware-related costs of $0.5 million.expenses.

Added

Sales and marketing expenses increased by $20.7 million, or 25%, for the year ended December 31, 2025, compared to the year ended December 31, 2024. The increase was primarily attributable to increases of $15.4 million in personnel-related costs, $4.5 million in marketing expenses, $3.2 million in consulting expenses and $0.5 million in travel expenses, partially offset by a decrease of $2.9 million in stock-based compensation expense.

Added

General and administrative

Reworded

SalesGeneral and marketingadministrative expenses decreased by $1.6$17.6 million, or (2)%,14%, for the year ended December 31, 2024,2025, compared to the year ended December 31, 2023,2024. The decrease was primarily dueattributable to adecreases decreaseof $25.7 million in stock-based compensation expense and $2.4 million in legal and consulting expenses, partially offset by increases of $1.4$3.7 million,million in software-related costs, $2.9 million in personnel-related costs, $2.3 million in a decreaseone-time impairment charge related to an intangible asset and associated construction in progress, $1.0 million in equipment related expenses and $0.6 million in travel costs of $0.6 million and a decrease in tradeshows and events of $1.6 million, offset by an increase in personnel-related costs of $2.2 million.expenses.

Added

Litigation expense

Added

The change in litigation settlement expense was mainly due reversal of litigation expense in 2024 related to the favorable outcome of patent infringement claims filed by Natera against us where the District Court ruled that the patents asserted against us were invalid, which was partially offset by settlement of the Securities Class Action lawsuit during 2025. See Note 8, Commitments and Contingencies, to the consolidated financial statements included elsewhere in this Annual Report on Form 10-K under the caption “Litigation and Indemnification Obligations”, which is incorporated herein by reference.

Removed

General and administrative expenses increased by $5.9 million, or 5%, for the year ended December 31, 2024, compared to the year ended December 31, 2023, primarily due to an increase in stock-based compensation expense of $19.5 million, and an increase in personnel-related costs of $8.8 million, offset by a decrease in legal expenses of $18.5 million, a decrease in other expenses of $4.5 million. The increase in stock-based compensation expense was primarily due to accelerated vesting over a shortened service period for awards held by the former CEO and former General Counsel of $14.3 million.

Removed

Restructuring costs

Removed

Restructuring costs decreased by $0.5 million for the year ended December 31, 2024, compared to the year ended December 31, 2023, primarily due to lesser headcount impacted by restructuring.

Removed

Litigation expense relates to the patent infringement claims filed by Natera against us and alleged that our product, AlloSure, infringes Natera's U.S. Patent 11,111,544. The jury awarded Natera an amount of $96.3 million and we recorded the amount as litigation expense for the year ended December 31, 2023. In February 2025, the District Court ruled that the patents asserted against us are invalid. We reversed the $96.3 million of litigation expense in the year ended December 31, 2024.

Reworded

Interest income, net, decreased by $0.1$2.6 million for the year ended December 31, 2024,2025, compared to the year ended December 31, 2023,2024, primarily due to a decrease in interestcash, rates.cash equivalents, and marketable securities.

Added

Other income, net increased by $0.2 million for the year ended December 31, 2025, compared to the year ended December 31, 2024, primarily due to an increase in foreign exchange gains.

Removed

During the year ended December 31, 2023, the following events occurred: a $1.0 million gain from settlement of an obligation and a $1.1 million gain from the recovery of an impaired loan that was already written-off, offset by a decrease in unrealized investment loss of $0.3 million. During the year ended December 31, 2024, there was a $0.5 million gain from a reduction in contingent consideration and an increase in other business expense of $0.3 million. These resulted in a decrease in other income, net, of $1.0 million for the year ended December 31, 2024, compared to the year ended December 31, 2023.

Reworded

For the year ended December 31, 2024,2025, we recorded an income tax expense of $0.3 million on ana incomeloss before income taxes of $52.9$21.1 million. The effective tax rate for the twelve monthsyear ended December 31, 20242025 differs from the federal statutory tax rate mainly due to the change in valuation allowance, windfallunrecognized tax benefitsbenefits, from stock-based compensation, nondeductiblenon-deductible executive compensation and taxstock-based credits.compensation.

Removed

For the year ended December 31, 2023, we recorded an income tax expense of $0.1 million on a loss before income taxes of $190.1 million. The difference in the effective tax rate for the year ended December 31, 2023 from the federal statutory tax rate is mainly due to the state income tax expense per the new research and development regulations, whereas in prior years we only recognized the deferred tax assets from foreign losses with the full valuation allowance.

Reworded

We have incurred significant losses and negative cash flows from operations since our inception and had an accumulated deficit of $626.2$735.4 million at December 31, 2024.2025. As of December 31, 2024,2025, we had cash, cash equivalents and marketable securities of $260.7$201.4 million, and no debt outstanding.

Reworded

Stock Repurchase ProgramPrograms

Added

On February 20, 2025, our Board of Directors approved the February 2025 Repurchase Program, whereby we were authorized to purchase up to $50.0 million in shares of our common stock over a period of up to two years, commencing on February 20, 2025, through open market purchases, one or more Rule 10b5-1 trading plans, block trades and in privately negotiated transactions. During the three months ended June 30, 2025, we repurchased an aggregate of 3.0 million shares of our common stock under the February 2025 Repurchase Program for an aggregate purchase price of $50.0 million.

Reworded

OnFollowing Decemberthe 3,completion 2022,of the February 2025 Repurchase Program, on May 30, 2025, our Board of Directors approvedauthorized oura Stocknew Repurchaseshare Program,repurchase orprogram the Repurchase Program, whereby we may purchaseof up to $50$50.0 million in shares of our common stock over a period of up to two years, commencing on DecemberMay 8,30, 2022.2025, or the May 2025 Repurchase Program. The May 2025 Repurchase Program may be carried out, subject to approval by thea committee of theour Board of Directors, through open market purchases, one or more Rule 10b5-1 trading plans andplans, block trades and in privately negotiated transactions. During the year ended December 31, 2024,2025, we purchased an aggregate of 55,5002.8 million shares of our common stock under the May 2025 Repurchase Program for an aggregate purchase price of $0.5$37.8 million. TheAs of December 31, 2025, $12.2 million was available for future share repurchases under the May 2025 Repurchase Program was renewed on February 20, 2025 where we may purchase up to $50 million in shares of our common stock over a period of up to two years, commencing on February 20, 2025.Program.

Added

During the year ended December 31, 2025, we purchased an aggregate of 5.8 million shares of our common stock under the February 2025 and May 2025 Repurchase Programs, for a total purchase price of $87.8 million.

Reworded

Net cash provided by operating activities for the year ended December 31, 20242025 was $38.0$42.0 million. Net operating assets decreasedincreased by $102.3$3.8 million. Our noncash items included $66.4$34.9 million in stock-based compensation expense, $14.2$15.0 million of depreciation and amortization expense, $5.6$5.4 million of amortization of right-of-use assets, $0.6$2.3 million of impairment of intangible asset and associated construction in progress, $1.3 million of amortization of premium on short-term marketable securities, net, and revaluation of contingent consideration to estimated fair value of $0.9$0.7 million.

Reworded

Net cash usedprovided inby operating activities for the year ended December 31, 20232024 was $18.4$38.0 million. Net operating assets decreased by $102.3 million. Our netnoncash loss of $190.3 million was our primary use of cash in operating activities. Our net loss alsoitems included the following noncash items: $49.1$66.4 million in stock-based compensation expense, $14.4$14.2 million of depreciation and amortization expense, $5.6 million of amortization of right-of-use assetsassets, $0.6 million of $5.4 million, asset impairments and write-downs of $1.0 million, amortization of premium on short-term marketable securities, net of $4.9 million, gain on settlement of obligation and recovery of written-off investment of $2.1 millionsecurities and revaluation of contingent consideration to estimated fair value of $2.7$0.9 million. Cash used in operating activities was also due to an increase in accounts receivable of $16.0 million. Cash used in operating activities was partially offset by an increase in net operating assets of $90.6 million including litigation expense of $96.3 million recorded as other liabilities related to the jury award in the Natera IP infringement matter.

Removed

For the year ended December 31, 2024, net cash used in investing activities was $0.5 million and primarily related to purchase of short-term marketable securities of $160.3 million, additions of capital expenditures of $6.5 million and purchase of corporate equity securities of $0.6 million, offset by maturities of short-term marketable securities of $166.9 million.

Reworded

For the year ended December 31, 2023,2025, net cash provided by investing activities was $40.4$2.2 million and primarily related to proceeds from maturities of marketable securities of $256.0$154.7 million and sale of corporate equity securities of $2.5 million. These proceeds weremillion, partially offset by the purchase of short-term marketable securities of $201.2$145.9 million, additions of capital expenditures of $8.3 million, payments for acquired intangibles of $0.9 million, purchase of corporate equity securities of $1.0$5.9 million and $0.7 million related to acquisition of business,an netintangible of cash acquired of $6.7 million.asset.

Added

For the year ended December 31, 2024, net cash used in investing activities was $0.5 million and primarily related to purchase of marketable securities of $160.3 million, additions of capital expenditures of $6.5 million and purchase of corporate equity securities of $0.6 million, offset by maturities of marketable securities of $166.9 million.

Added

Net cash used in financing activities for the year ended December 31, 2025 was $93.4 million and primarily related to repurchase and retirement of common stock of $87.8 million, taxes paid related to net share settlements of restricted stock units of $12.1 million and payments of contingent consideration of $1.5 million. These payments were partially offset by the proceeds from exercises of stock options of $5.7 million and proceeds from issuances of shares of common stock under our employee stock purchase plan of $2.3 million.

Removed

Net cash used in financing activities for the year ended December 31, 2023 was $29.6 million and primarily related to repurchase and retirement of common stock of $27.5 million, taxes paid related to net share settlements of restricted stock units of $3.1 million and payments of contingent consideration of $0.6 million. These payments were partially offset by the proceeds from exercises of stock options of $0.1 million and proceeds from issuances of shares of common stock under our employee stock purchase plan of $1.5 million.

Reworded

For a discussion regarding our significant contractual obligations as of December 31, 20242025 and the effect those obligations are expected to have on our liquidity and cash flows in future periods, please refer to Note 9,8, Commitments and Contingencies, of the consolidated financial statements, and “Results of Operations—Liquidity and Capital Resources”, respectively, included elsewhere in this Annual Report on Form 10-K.

Added

Refunds Reserve

Added

With respect to revenue recognized related to testing services whereby consideration is expected to be received from third-party payers, we recognized a constraint to the estimated variable consideration such that it is not probable that a significant revenue reversal will occur. When assessing the total consideration expected to be received from third-party payers, a certain percentage of revenues is further constrained for estimated refunds.

Showing the first 60 of 74 changed paragraphs. The complete comparison will be part of Pro (coming soon). Meanwhile you can read the full text in the original filing.

What changed in the latest 10-Q

Comparing 10-Q filed 2026-07-30 (period ending 2026-06-30) with 10-Q filed 2026-04-28 (period ending 2026-03-31).

Risk Factors (10-Q Part II, Item 1A)

6new paragraphs
8removed paragraphs
38reworded paragraphs
28,746 → 28,565words in section

Removed heading “Disputes with labor unions may adversely affect our ability to operate in our Sweden facility and may impact our financial results.”

Removed heading “Our License and Commercialization Agreement with Illumina may not result in material benefits to our business.”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

Removed text topics: labor
“Disputes with labor unions may adversely affect our ability to operate in our Sweden facility and may impact our financial results.”
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Removed text topics: strike, labor
“Our production group in Sweden is represented by an IF Metall collective bargaining agreement. Our failure to successfully renegotiate this labor agreement as it expires could lead to work stoppages or other disputes with labor unions. Our manufacturing facility in Sweden is used to support the production, packaging and labeling of our proprietary test kits: Olerup SSP, QTYPE, AlloSeq cfDNA and HCT. Disruptions to our manufacturing facility through various forms of labor disputes could adversely affect us. …”
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Removed text
“Our License and Commercialization Agreement with Illumina may not result in material benefits to our business.”
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Reworded topics: fine

Paragraph as it now reads, with added and removed wording marked:

On August 10, 2023, MolDX and Noridian released a draft proposed revision to the LCD (DL38568, Palmetto; DL38629, Noridian) that, if adopted, would revise the existing foundational LCD, MolDX: Molecular Testing for Solid Organ Allograft Rejection (L38568 and L38629). On August 16, 2024, CMS issued a press release entitled “MolDX Local Coverage Determination Statement,” announcing that after careful consideration of the feedback received from interested parties, as well as the public comments and further review of evidence, the Medicare Administrative Contractors, or MACs, decided not to finalize the proposed LCD issued on August 10, 2023. CMS further stated that due to the importance of identifying solid organ allograft rejection early and to ensure the public has additional opportunities to comment on the policy, the MACs intend to issue a new LCD in the coming months. CMS stated that neither it nor the MACs have changed coverage for the blood tests that monitor for organ transplantation rejection when ordered by their physicians in medically appropriate circumstances, and explained that transplant patients would continue to have access to these blood tests, including: when there are signs or symptoms of rejection; after a physician-assessed pretest, including for surveillance testing; after an indeterminate biopsy; as a replacement for a biopsy when deemed clinically appropriate by the patient’s qualified physician; and for evaluation of the adequacy of immunosuppression. On July 17, 2025, MolDX and Noridian released a new draft proposed revision to the existing foundational LCD (DL40058, DL40060) with a revised accompanying billing article (DA60146, DA60152), or the Proposed LCD. On July 16, 2026, a Final LCD (L40060) and billing article (A60152) was published and is expected to take effect on August 30, 2026. The ProposedFinal LCD,LCD which underwent public comment, may introduce newaffirms coverage criteria,across utilizationour limitations,transplant testing offerings in kidney, heart, and alung, newincluding bundledfor-cause paymentand conceptsurveillance testing, with defined coverage criteria. While the Final LCD affirms coverage for certainthese CareDx testing, which could lead to lower rates of reimbursement. MolDX and Noridian have 365 days from the date of issuance to finalize the Proposed LCD. We cannot predict the ultimate outcome of the LCD process, including as it relates to the Proposed LCD, and whether it will produceofferings, changes in coverage,coverage reimbursement practices,criteria, utilization limitations, or payment amounts, anyincluding as a result of whichany future revisions to the LCD, could adversely affect our business, operating results and prospects.
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Reworded topics: labor

Paragraph as it now reads, with added and removed wording marked:

If we failedfail to secure or maintain any suchrequired certifications or licenses, we would notmay be ableunable to process samples from recipientscertain instates suchor states.offer Weparticular alsotests from specific laboratory locations. In addition, we expect that it would be difficult, time-consuming and costly to qualify, train, equip and useoversee a third-partythird party to perform tests on our behalf. WeEven couldthough multiple CLIA-certified laboratories exist, only use another facilitylaboratories with the establishednecessary certifications, state licensureslicenses, technical capabilities, validated methods and CLIAquality certificationsystems necessary tocould perform AlloSureour Kidney, AlloMap Heart, AlloSure Heart, HeartCare, AlloSure Lung or future solutionstests following appropriate technology transfer, validation and other required procedures. We cannot be certain that we would be able to findsuccessfully transfer testing to another CLIA-certifiedlaboratory, facilitywhether willinginternal or ableexternal, towithin adoptan AlloSureacceptable Kidney, AlloMap Heart, AlloSure Heart, HeartCare, AlloSure Lung or future solutions or able to comply with the required quality and regulatory standards,timeframe, or that thisany such laboratory would be willing or able to perform theour tests forin uscompliance onwith commerciallyapplicable reasonablequality, terms.regulatory and commercial requirements. As a result, disruptions affecting one or more of our laboratories could materially adversely affect our business, financial condition and results of operations.
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Removed text topics: competition
“We expect the competition for pre-transplant typing and post-transplant surveillance to increase as there are numerous established and startup companies in the process of developing products and services for the transplant market which may directly or indirectly compete with our existing pre- and post-transplant solutions, or our development pipeline. Competition from other companies, especially those with an eye toward transitioning to more automated typing processes, could impact our ability to maintain market share and its current margins. …”
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Full comparison: every changed paragraph (52)

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Reworded

We have a history of net losses, and we expectmay tonot incursustain net losses for the next several years.profitability.

Reworded

We have incurreda history of substantial net losses since our inception, and we may continue to incur additionalnet losses forin thefuture next several years.periods. For the three months ended MarchJune 31,30, 2026, our net income was $2.8$110.6 million and for the three months ended MarchJune 31,30, 2025, our net loss was $10.4$8.6 million. As of MarchJune 31,30, 2026, we had an accumulated deficit of $732.5$505.4 million. Although we reported net income of $2.8$110.6 million for the three months ended MarchJune 31,30, 2026, we have not consistently achieved profitability and there can be no assurance that we will be able to sustain profitability on a quarterly or annual basis. We expect to continue to incur significant operating expenses and anticipate that our expenses will increase due to costs relating to, among other things:

Reworded

•researching, developing, validating and commercializing potential new testing services, productsservices and patient and digital solutions, including additional expenses in connection with our continuing development and commercialization of our testing services and product portfolio, and other future solutions;

Reworded

For the three months ended MarchJune 31,30, 2026, revenue from Medicare for AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare and AlloSure Lung represented 35%37% of our testing services revenue and 30% of our total revenue. However, we may not be able to maintain or increase our tests reimbursed by Medicare for a variety of reasons, including changes in reimbursement practices, general policy shifts, or reductions in reimbursement amounts. We cannot predict whether Medicare reimbursements will continue at the same payment amount or with the same breadth of coverage in the future, if at all. For example, on December 30, 2024, we received a CPT code for our AlloSure Kidney, AlloSure Heart and AlloSure Lung tests (PLA Code 0540U), which subjects such tests to a repricing process. On November 25, 2025, CMS issued a final determination to cross-walk AlloSure (0540U) to CPT code 0493U. As a result, PLA Code 0540U was listed on the Clinical Laboratory Fee Schedule effective January 1, 2026 at approximately $2,753. The new reimbursement rate represents an $88 decrease to the previous pricing for our AlloSure Kidney test, and no change to the pricing for AlloSure Heart and AlloSure Lung tests.

Reworded

On August 10, 2023, MolDX and Noridian released a draft proposed revision to the LCD (DL38568, Palmetto; DL38629, Noridian) that, if adopted, would revise the existing foundational LCD, MolDX: Molecular Testing for Solid Organ Allograft Rejection (L38568 and L38629). On August 16, 2024, CMS issued a press release entitled “MolDX Local Coverage Determination Statement,” announcing that after careful consideration of the feedback received from interested parties, as well as the public comments and further review of evidence, the Medicare Administrative Contractors, or MACs, decided not to finalize the proposed LCD issued on August 10, 2023. CMS further stated that due to the importance of identifying solid organ allograft rejection early and to ensure the public has additional opportunities to comment on the policy, the MACs intend to issue a new LCD in the coming months. CMS stated that neither it nor the MACs have changed coverage for the blood tests that monitor for organ transplantation rejection when ordered by their physicians in medically appropriate circumstances, and explained that transplant patients would continue to have access to these blood tests, including: when there are signs or symptoms of rejection; after a physician-assessed pretest, including for surveillance testing; after an indeterminate biopsy; as a replacement for a biopsy when deemed clinically appropriate by the patient’s qualified physician; and for evaluation of the adequacy of immunosuppression. On July 17, 2025, MolDX and Noridian released a new draft proposed revision to the existing foundational LCD (DL40058, DL40060) with a revised accompanying billing article (DA60146, DA60152), or the Proposed LCD. On July 16, 2026, a Final LCD (L40060) and billing article (A60152) was published and is expected to take effect on August 30, 2026. The ProposedFinal LCD,LCD which underwent public comment, may introduce newaffirms coverage criteria,across utilizationour limitations,transplant testing offerings in kidney, heart, and alung, newincluding bundledfor-cause paymentand conceptsurveillance testing, with defined coverage criteria. While the Final LCD affirms coverage for certainthese CareDx testing, which could lead to lower rates of reimbursement. MolDX and Noridian have 365 days from the date of issuance to finalize the Proposed LCD. We cannot predict the ultimate outcome of the LCD process, including as it relates to the Proposed LCD, and whether it will produceofferings, changes in coverage,coverage reimbursement practices,criteria, utilization limitations, or payment amounts, anyincluding as a result of whichany future revisions to the LCD, could adversely affect our business, operating results and prospects.

Added

NavDx® has been a covered service for Medicare beneficiaries since November 2023 through an LCD issued by Palmetto GBA. It is priced nationally at $1,800 under CPT Code 0356U.

Reworded

On a five-year rotational basis, Medicare requests bids for its regional MAC services. The MAC for California is currently Noridian Healthcare Solutions. The MAC for North Carolina is Palmetto GBA. Our current Medicare coverage through Noridian and Palmetto GBA provides for reimbursement for tests performed for qualifying Medicare patients throughout the United States so long as the tests are performed in our California laboratory.and North Carolina laboratories. We cannot predict whether NoridianNoridian, Palmetto GBA, or any future MAC will continue to provide reimbursementcoverage for AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare, AlloSure Lung, or AlloSure Lung at the same payment amount orNavDx® with the same breadth of coverage in the future, if at all. Additional changes in the MAC processing Medicare claims for AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCareHeartCare, AlloSure Lung, or AlloSure LungNavDx® could impact the coverage or payment amount for our tests and our ability to obtain Medicare coverage for any products we may launch in the future.

Reworded

Clinicians and healthcare administrators are traditionally slow to adopt new products, testing practices and clinical treatments, partly because of perceived liability risks and the uncertainty of third-party reimbursement. It is critical to the success of our sales efforts that we continue to educate clinicians, administrators and laboratory directors about our testing services, productsservices and patient and digital solutions, and demonstrate the clinical and diagnostic benefits of these services, products and patient and digital solutions. We believe that clinicians, transplant centers and laboratories may not use our services, productsservices and patient and digital solutions unless they determine, based on published peer-reviewed journal articles, the experience of other clinicians or laboratory verification, that our services, productsservices and patient and digital solutions provide accurate, reliable and cost-effective information that is useful in pre-transplant matching and monitoring their post-transplant recipients. The acceptance of our services, productsservices and patient and digital solutions will depend upon our ability to demonstrate the safety and efficacy, advantages, short and long-term clinical performance and cost-effectiveness of our services, productsservices and patient and digital solutions.

Removed

Our product kits are sold to hundreds of laboratories, mainly in Europe and the U.S. Laboratories order our products based on the accuracy, speed and cost of the test together with the cost and availability of equipment on which to run the test. Switching to or adopting our products may require the purchase of new and costly testing equipment. To attract new laboratory customers, the performance of our products must provide performance or cost advantages over similar products sold by our competitors.

Reworded

If clinicians, hospital administrators and laboratories do not adopt or continue to use our tests and products or our future solutions and tests, our business and financial results will suffer.

Reworded

Competition for our AlloSure Heart, AlloMap Heart, and HeartCare solutions for heart transplant recipients comes largely from biopsies in the first few years, which generally involves evaluating biopsy samples to determine the presence or absence of rejection. Beyond the first year or two, competition for heart transplant surveillance diagnostics includes echocardiography. Throughout, biopsy and echocardiography are supplemented by general, non-specific clinical chemistry tests such as, immunosuppression drug levels, donor specific antibodies and others that are widely ordered by physician offices and routinely performed in clinical reference labs and hospital labs. This practice has been the standard of care in the United States for many years, and we will need to continue to educate clinicians, transplant recipients and payers about the various benefits of our test in order to change clinical practice. Our competitors also include companies that are focused on the development and commercialization of molecular diagnostic tests. In the field of post-transplant surveillance, Natera and Eurofins hashave commercially available molecular diagnostics tests.

Removed

We expect the competition for pre-transplant typing and post-transplant surveillance to increase as there are numerous established and startup companies in the process of developing products and services for the transplant market which may directly or indirectly compete with our existing pre- and post-transplant solutions, or our development pipeline. Competition from other companies, especially those with an eye toward transitioning to more automated typing processes, could impact our ability to maintain market share and its current margins. For example, QTYPE competes with other quantitative polymerase chain reaction, or PCR, products including products offered by Thermo Fisher, as well as alternatives to PCR such as next generation sequencing, or NGS, typing products.

Reworded

From 2024 to 2025, our revenue increased from $333.8 million to $379.8 million, which represents an increase of 14%. From the three months ended MarchJune 31,30, 2025 to the three months ended MarchJune 31,30, 2026, our revenue increased from $84.7$86.7 million to $117.7$131.9 million, which represents an increase of $33.0$45.3 million or 39%.52%. In the future, our revenue may not grow at all and it may continue to decline. We believe that our future revenue will depend on, among other factors:

Reworded

•demand for our testing services, productsservices and patient and digital solutions;

Added

We perform our testing services for the United States in laboratories located in Brisbane, California, Waltham, Massachusetts and Durham, North Carolina. While we operate multiple laboratory facilities, our testing operations are not fully redundant, and not all of our tests can be readily performed at each laboratory location. Certain tests, including our AlloSure, AlloMap, NavDx® offerings, rely on specialized equipment, workflows, personnel training, quality systems, regulatory approvals, and laboratory-specific validations that would require significant time, expense and regulatory review to replicate or transfer to another facility.

Added

Brisbane, California is situated on or near earthquake fault lines. The Durham facility is subject to risks associated with hurricanes, tropical storms, severe weather, flooding and prolonged power disruptions that may impact our operations, supply chain, workforce availability and transportation networks. The Waltham facility is subject to risks associated with severe winter storms, extreme precipitation, flooding and other weather-related events that may disrupt operations, transportation networks and utility services.

Reworded

We perform all of our testing services for the United States in our laboratory located in Brisbane, California. We do not have redundant laboratory facilities. Brisbane, California is situated on or near earthquake fault lines. Our facilityfacilities and the equipment we use to perform testing services would be costly to replace and could require substantial lead time to repair or replace if damaged or destroyed. Our facilities may be harmed or rendered inoperable by natural or man-made disasters, including earthquakes, power outages, wildfires, flooding, hurricanes, droughts and other extreme weather events and changing weather patterns, which are increasing in frequency due to the impacts of climate change and may render it difficult or impossible for us to perform our tests for some period of time. TheAlthough our multiple laboratory locations may provide some operational flexibility, a disruption at a facility performing a specific test may materially affect our ability to provide that test until operations can be transferred, validated and scaled at another location. Any inability to perform our tests may result in the loss of customerscustomers, ordelays in patient testing, harm to our reputation,reputation and reduced revenue, and we may be unable to regain thoseaffected customers in the future. Although we possessmaintain insurance for damage to our property and the disruption of our business, we do not have earthquake insurance and thus coverage may not be sufficient to cover all of our potential losses and may not continue to be available to us on acceptable terms, if at all. We do not know, however, if we will be able to maintain existing insurance with adequate levels of coverage, and, in the event of a major earthquake in our region, our business could suffer significant and uninsured damage and loss.

Reworded

InWhile orderwe may seek to establishexpand atesting redundantcapabilities across existing or additional laboratory facility,facilities, wedoing so would have to spendrequire considerable time and moneyexpense, including securing adequate space, constructinginstalling theand facility,qualifying equipment, recruiting and training employeespersonnel, conducting analytical and clinical validation activities, obtaining any required regulatory approvals, and establishing the additional operational and administrative infrastructure necessary to support atesting secondservices. facility. Additionally, anyAny new clinical laboratory facility openedestablished by us in the United States would be required to be certified under the Clinical Laboratory Improvement Amendments of 1988, or CLIA, a federal law that regulates clinical laboratories that perform testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention or treatment of disease. Weand would also be required to secure and maintain applicable state licenses required by several states,licenses, including in states such as California, Florida, Maryland, New York, Rhode Island and Pennsylvania, which can take a significant amount of time and result in delays in our ability to begin operations at that facility.Pennsylvania.

Added

Obtaining and maintaining such certifications and licenses may be time-consuming and could delay our ability to commence operations or offer specific testing services at a facility.

Reworded

If we failedfail to secure or maintain any suchrequired certifications or licenses, we would notmay be ableunable to process samples from recipientscertain instates suchor states.offer Weparticular alsotests from specific laboratory locations. In addition, we expect that it would be difficult, time-consuming and costly to qualify, train, equip and useoversee a third-partythird party to perform tests on our behalf. WeEven couldthough multiple CLIA-certified laboratories exist, only use another facilitylaboratories with the establishednecessary certifications, state licensureslicenses, technical capabilities, validated methods and CLIAquality certificationsystems necessary tocould perform AlloSureour Kidney, AlloMap Heart, AlloSure Heart, HeartCare, AlloSure Lung or future solutionstests following appropriate technology transfer, validation and other required procedures. We cannot be certain that we would be able to findsuccessfully transfer testing to another CLIA-certifiedlaboratory, facilitywhether willinginternal or ableexternal, towithin adoptan AlloSureacceptable Kidney, AlloMap Heart, AlloSure Heart, HeartCare, AlloSure Lung or future solutions or able to comply with the required quality and regulatory standards,timeframe, or that thisany such laboratory would be willing or able to perform theour tests forin uscompliance onwith commerciallyapplicable reasonablequality, terms.regulatory and commercial requirements. As a result, disruptions affecting one or more of our laboratories could materially adversely affect our business, financial condition and results of operations.

Reworded

Ongoing focus on corporate responsibility matters by investors, stockholders, lawmakers, listing exchanges or other constituencies may impose additional costs or expose us to new risks. In addition, in March 2024, the SEC adopted rules that, among other matters, establish a framework for reporting of climate-related risks. However, the SEC voluntarily stayed implementation of the final rules pending completion of judicial review. ToIn 2026, the extentSEC proposed to rescind the proposedclimate-related disclosure rules survivein ongoingtheir entirety. The ultimate outcome and possiblytiming additionalof forthcomingany legalrescission challenges,remain theyuncertain. In addition, we are or may become subject to state-level and non-U.S. climate-related disclosure requirements, which may impose additional reporting obligations,obligations and wecause couldus to incur increased costs.

Reworded

As of MarchJune 31,30, 2026, we had cash,cash and cash equivalents and marketable securities of $198.1$373.6 million and an accumulated deficit of $732.5$505.4 million. We expect capital outlays and operating expenditures to increase over the next several years as we expand our infrastructure, commercial operations and research and development activities. Specifically, we may need to raise additional capital to, among other things:

Reworded

We rely extensively on third-party service providers. Failure of these parties to perform as expected, or interruptions in our relationship with these providers or their provision of services or supplies to us, could interfere with our ability to provide test results for our testing services business and kits for our products business.

Reworded

We rely solely on certain suppliers to supply some of the laboratory instruments and key reagents that we use in the production of our products and/or in the performance of our tests. The failure of these suppliers to perform as expected, or an interruption in our relationship with them, could interfere with our ability to provide our products and tests. These sole source suppliers include Thermo Fisher, which supplies us with instruments, laboratory reagents and consumables; Roche Molecular Systems, which supplies us with laboratory reagents and consumables; Illumina, Inc., or Illumina, which supplies us with instruments, laboratory reagents and consumables; Becton, Dickinson and Company, and Streck, which suppliessupply us with cell preparation tubes; Beckman Coulter, which provides laboratory reagents and consumables; Takara, which supplies us with reagents; IDT, which supplies us with reagents; Avantor, which supplies us with consumables; and Qiagen N.V., which supplies us with a proprietary buffer reagent and reagent kits.kits and Bio-Rad which supplies us with instruments, laboratory reagents, and consumables. We do not have guaranteed supply agreements with Thermo Fisher, Becton, Dickinson and Company or Avantor, which exposes us to the risk that these suppliers may choose to discontinue doing business with us at any time. We periodically forecast our needs to these sole source suppliers and enter into standard purchase orders based on these forecasts.

Reworded

As part of our longer-term growth strategy, we intend to target select international markets to grow our presence outside of the United States. We also currently distribute products in Europe, Canada, Asia, the Middle East, and Central and South America.Canada. To promote the growth of our business internationally, we will need to attract additional partners to expand into new markets.

Reworded

At the same time, use of AI has recently become the subject of significant media attention and political debate. As we integrate or consider integrating AI—including generative AI—into new or existing offerings, we may face new or expanded risks and liabilities, including enhanced governmental or regulatory scrutiny, litigation, compliance issues, ethical concerns, confidentiality or security risks, as well as other factors that could adversely affect our reputation, our business, operating results and financial condition. AI-enabled features may not perform as intended, may produce inaccurate, deficient, misleading or otherwise flawed outputs, or may reflect unintended biases and discriminatory outcomes. In a healthcare context, such issues could negatively impact clinicians, patients and our customers, require additional validation, human oversight and post‑market monitoring, result in product complaints or recalls, and expose us to product liability and professional liability claims. In addition, laws, regulations or industry standards governing AI use are evolving and may be burdensome or restrict our ability to develop, deploy or update AI in our products or processes, including potential frameworks for AI/ML‑enabled medical device software in the United States and the EU AI Act, as well as emerging U.S. federal, state and local rules.

Removed

Disputes with labor unions may adversely affect our ability to operate in our Sweden facility and may impact our financial results.

Removed

Our production group in Sweden is represented by an IF Metall collective bargaining agreement. Our failure to successfully renegotiate this labor agreement as it expires could lead to work stoppages or other disputes with labor unions. Our manufacturing facility in Sweden is used to support the production, packaging and labeling of our proprietary test kits: Olerup SSP, QTYPE, AlloSeq cfDNA and HCT. Disruptions to our manufacturing facility through various forms of labor disputes could adversely affect us. Any strike, work stoppage, or other dispute with a labor union distracts management from operating the business, may displace employees from ordinary job positions to fill in vacant positions, may affect our reputation, and could materially adversely affect our business, results of operations, and financial condition.

Reworded

Many of the countries in which we operate, including the U.S. and several of the members of the European UnionU.S., have experienced and continue to experience uncertain economic conditions resulting from global as well as local factors. Our business or financial results may be adversely impacted by these uncertain economic conditions, including: adverse changes in interest rates, foreign currency exchange rates, tax laws or tax rates; the imposition of trade barriers such as tariffs (and judicial uncertainty about their enforceability), quotas, trade wars, preferential bidding or import or export licensing requirements; increased inflation globally and in the U.S. in particular; liquidity concerns at financial institutions; a potential economic recession; contraction in the availability of credit in the marketplace due to legislation or other economic conditions, which may potentially impair our ability to access the capital markets on terms acceptable to us or at all; and the effects of government initiatives to manage economic conditions. Moreover, disagreement over the federal budget has caused the U.S. federal government to shut down for periods of time. Continued adverse political conditions or a severe or prolonged economic downturn, such as the global financial crisis, could result in a variety of risks to our business, including a decrease in the demand for our tests and in our ability to raise additional capital when needed on acceptable terms, if at all. In addition, we cannot predict how future economic conditions will affect our critical customers, suppliers and distributors and any negative impact on our critical customers, suppliers or distributors may also have an adverse impact on our results of operations or financial condition. We cannot anticipate all of the ways in which the foregoing, and the current economic climate and financial market conditions generally, could adversely impact our business.

Reworded

Additionally, the U.S. Congress recently enacted the One Big Beautiful Bill Act, or the OBBBA, in July 2025, which includes significant provisions, including tax cut extensions and modifications to the international tax framework, and the restoration of the immediate deductibility of domestic research and development expenditures beginning with our 2025 taxable year.

Reworded

We may not be able to achieve the anticipated strategic benefits from our acquisition of Naveris, Ottr, XynManagement, TransChart, MedActionPlan, TTP, HLA Data Systems, or any other businesses or assets that we may acquire.

Reworded

The integration of any businesses or assets we may acquireacquire, including our recently completed acquisition of Naveris, will be a time-consuming process. The integration process will require substantial management time and attention, which may divert attention and resources from other important areas, including our existing business. In addition, we may not be able to fully realize the anticipated strategic benefits of any such combination or integration and any other businesses or assets we have or may acquire, which includes, with respect to Naveris, its specialty oncology testing business, including minimal residual disease and recurrence monitoring, with respect to Ottr, the complementary Ottr software, with respect to XynManagement, XynQAPI, TransChart and MedActionPlan, as well as TTP, and HLA Data Systems services and technologies, and in each case the benefits of any significant cross-selling opportunities. If we are not able to achieve the anticipated strategic benefits of any such combination, it could adversely affect our business, financial condition and results of operations, and could adversely affect the market price of our common stock if the anticipated financial and strategic benefits of the acquisition are not realized as rapidly as, or to the extent anticipated by investors and analysts. Failure to achieve these anticipated benefits could result in increased costs and decreases in future revenue and/or net income following the acquisition.

Added

Our acquisition of Naveris also expands our business beyond our historical focus on transplant diagnostics and related patient and digital solutions into specialty oncology testing, a market in which we have limited operating experience and which may involve different clinical adoption, reimbursement, regulatory, commercial and competitive dynamics. We may not be successful in integrating Naveris’s operations, technology, personnel, laboratory processes, quality systems, payer relationships, compliance programs, financial reporting and internal control processes, and we may fail to retain key personnel, customers, collaborators or commercial relationships.

Added

If we are not able to achieve the anticipated strategic benefits of any strategic combination, it could adversely affect our business, financial condition and results of operations, and could adversely affect the market price of our common stock if the anticipated financial and strategic benefits of the acquisition are not realized as rapidly as, or to the extent anticipated by investors and analysts. Failure to achieve these anticipated benefits could result in increased costs and decreases in future revenue and/or net income following the acquisition.

Removed

Our License and Commercialization Agreement with Illumina may not result in material benefits to our business.

Removed

Under the License and Commercialization Agreement, or the License Agreement, with Illumina, we are obligated to complete timely development and commercialization of future products, including meeting certain commercialization milestones. The failure to meet any such milestones could result in the loss of exclusivity for the affected licensed products. Additionally, we are required to pay royalties in the mid-single to low-double digits on sales of future commercialized products.

Removed

We cannot make any assurances that our efforts under the License Agreement will be successful. As a result, we may not be able to fully realize the anticipated strategic benefits of the License Agreement. If we fail to successfully execute on the License Agreement, we may not realize the benefits expected from the transaction and our business may be harmed.

Reworded

In the first quarter of 2025, we received a second UPIC records request with which we complied.Incomplied. In the second quarter of 2025, the UPIC notified us that it had received the medical records we provided in connection with such request and concluded that no further information was necessary at that time. The UPIC identified no overpayment in connection with the second request and thanked us for our cooperation.

Reworded

Finally, we may be subject to regulation in foreign jurisdictions where we offer our test. Failure to maintain certification in those states or countries where it is required could prevent us from testing samples from those states or countries, could lead to the suspension or loss of licenses, certificates or authorizations, and could have an adverse effect on our business. We were inspected as part of the customary College of American Pathologists audit and recertified in 2024 as a result of passing that inspection. We expectreceived thea next regularsuccessful inspection under the CLIA to occur in March 2026.

Reworded

In October 2023, the FDA proposed a new policy under which the FDA intends to provide greater oversight of LDTs, through a phase-out of its general enforcement discretion approach to LDTs. In connection with this, the FDA proposed a rule that would amend its regulations to make explicit that in vitro diagnostic products are devices under the Federal Food, Drug and Cosmetic Act. In April of 2025, the U.S. District Court for the Eastern District of Texas found that the FDA’s authority to promulgate rules over “medical devices” does not extend to “laboratory services.” In September 2025, the FDA issued a final rule reverting the text of the regulation as it existed prior to this change and limiting the FDA’s authority over our testing services. Following the decision, the current administration reverted the policy to suggest it would not exercise authority to regulate LDTs. There is no assurance whether, or when, thisthe proposedFDA policymay and/oragain ruleseek willto beregulate adoptedLDTs, or as to the content of any policies or rule that may eventually be adopted.

Reworded

Because of the breadth of these laws and the narrowness of available statutory and regulatory exemptions, it is possible that some of our business activities could be subject to challenge under one or more of such laws. Any action brought against us for violation of these laws or regulations, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business. We may be subject to private “qui tam” actions brought by individual whistleblowers on behalf of the federal or state governments, with potential liability under the federal False Claims Act, including mandatory treble damages and significant per-claim penalties. For violations assessed after July 3, 2025, the minimum FCA penalty increased from $13,946 to $14,308 per claim and the maximum penalty increased from $27,894 to $28,619 per claim. We previously received a civil investigative demand, or CID, from the United States Department of Justice, or DOJ, requesting that we produce certain documents in connection with a False Claims Act investigation being conducted by the DOJ regarding certain business practices related to our kidney testing and phlebotomy services, and a subpoena from the SEC in relation to an investigation by the SEC in respect of matters similar to those identified in the CID, as well as certain of our accounting and public reporting practices. As previously reported, the SEC has concluded its investigation and does not intend to recommend an enforcement action against us, and the DOJ declined to intervene in the related qui tam action and has closed its investigation with no finding of wrongdoing. AOn April 23, 2026, the private relator haswho had continued to pursue the qui tam action,action whichfiled a notice of voluntary dismissal, the CompanyDOJ isinformed vigorouslythe defending.court that it consented to dismissal of the action, and the District Court dismissed the case. We previously received a request for information from a separate state regulatory agency and may receive additional requests for information from the DOJ, the SEC or other regulatory and governmental agencies regarding similar or related subject matters. We do not believe that the CID, the prior SEC subpoena, or the state regulatory agency information request raised any issues regarding the safety or clinical utility of any of our products or services. Although the DOJ and SEC investigations have concluded, we cannot predict the outcome of the pending qui tam action or any other requests or investigations that may arise in the future regarding these or other subject matters. If our operations are found to be in violation of any of the federal, state and foreign laws described above or any other current or future fraud and abuse or other laws and regulations that apply to us, we may be subject to penalties, including significant criminal, civil, and administrative penalties, damages, fines, imprisonment for individuals, exclusion from participation in government programs, such as Medicare and Medicaid, injunctions, recall or seizure of products, total or partial suspension of production, denial or withdrawal of pre-marketing product approvals, and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations. In addition, if any governmental body, such as the DOJ or SEC, determines that we have not complied with applicable securities or other laws, such governmental body could initiate a proceeding against us, which may ultimately lead to significant penalties and other relief assessed against us, including monetary fines. Any of the foregoing consequences could seriously harm our business and our financial results.

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As of MarchJune 31,30, 2026, we had seveneight issued U.S. patents related to diagnosing transplant rejection and autoimmune disease, which will expire between August 2027 and May 2035. In addition, we had four U.S. patents related to organ function recovery and allograft preservation, which will expire between July 2038 and June 2041. In addition, through the acquisition of Naveris on July 1, 2026, the Company acquired five additional U.S. patents related to HPV-driven cancer detection and monitoring, which will expire between September 2039 and September 2041.

Reworded

Periodic maintenance fees on any issued patent are due to be paid to the U.S. Patent and Trademark Office, or the USPTO,PTO, and other foreign patent agencies in several stages over the lifetime of the patent. The USPTOPTO and various foreign national or international patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Noncompliance events that could result in abandonment or lapse of patent rights include, but are not limited to, failure to timely file national and regional stage patent applications based on our international patent application, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. If we or our licensors fail to maintain the patents and patent applications covering our products and services, our competitors might be able to enter the market, which would have an adverse effect on our business.

Reworded

In addition, revising our current or future solutions to exclude any infringing technologies would require us to re-validate the test, which would be costly and time-consuming. Also, we may be unaware of pending patent applications that relate to our current or future solutions. Parties making infringement claims on future issued patents may be able to obtain an injunction that would prevent us from selling our current or future solutions or using technology that contains the allegedly infringing intellectual property, which could harm our business. See Note 8, Commitments and Contingencies, to the consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q under the caption “Litigation and Indemnification Obligations,” which is incorporated herein by reference, for a discussion of our recently completed and ongoing litigation with Natera.

Reworded

•the possibility that the substantial amount of discovery required in connection with intellectual property litigation results in our confidential information being comprisedcompromised by disclosure during the litigation;

Reworded

AlloMap, AlloSure, Olerup SSP, QTYPE,NavDx®, Ottr and CareDx are registered trademarks of our company in the United States. Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented, declared generic or determined to be infringing on other marks. As a means to enforce our trademark rights and prevent infringement, we may be required to file trademark claims against third parties or initiate trademark opposition proceedings. This process can be expensive, particularly for a company of our size, and time-consuming. In addition, in an infringement proceeding, a court may decide that a trademark of ours is not valid or is unenforceable, or may refuse to stop the other party from using the trademark at issue. We may not be able to protect our rights to these and other trademarks and trade names which we need to build name recognition by potential partners or customers in our markets of interest. Over the long-term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively and our business may be adversely affected.

Removed

We license technology from third parties necessary to develop and commercialize our products. On May 4, 2018, we entered into the License Agreement with Illumina, which provides us with worldwide distribution, development and commercialization rights to Illumina’s NGS product line for use in transplantation diagnostic testing. These NGS products include: AlloSeq Tx, a high-resolution HLA typing solution, AlloSeq cfDNA, our surveillance solution designed to measure dd-cfDNA in blood to detect active rejection in transplant recipients, and AlloSeq HCT, an NGS solution for chimerism testing for stem cell transplant recipients.

Reworded

For example, we obtain health information (including from TTP) that is subject to privacy and security requirements under HIPAA, as amended by HITECH, which imposesimposes, among other things, certain requirements relating to the privacy, security, transmission, and breach of individually identifiable health information. If we violate HIPAA, depending on the specific facts and circumstances, we could be subject to significant fines, penalties or regulatory inquiries or actions.

Reworded

Fluctuations in our operating results may lead to fluctuations, including declines, in the share price for our common stock. From January 2, 2026 to MarchJune 31,30, 2026, our closing stock price ranged from $16.43$16.05 to $21.02$29.28 per share. Our operating results and our share price may fluctuate from period to period due to a variety of factors, including:

Reworded

Variations in the timing of our future revenues and expenses could also cause significant fluctuations in our operating results from period to period and may result in unanticipated earningearnings shortfalls or losses. In addition, national stock exchanges, and in particular the market for life science companies, have experienced significant price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of those companies. Moreover, we may be subject to additional securities class action litigation as a result of volatility in the price of our common stock, which could result in substantial costs and diversion of management’s attention and resources and could harm our stock price, business, prospects, results of operations and financial condition.

Reworded

During the three and six months ended MarchJune 31,30, 2026, wethe didCompany notpurchased repurchasean anyaggregate of 0.6 million shares of ourits common stock under the May 2025 Repurchase Program.Program for an aggregate purchase price of $12.2 million. As of MarchJune 31,30, 2026, $12.2no millionamounts waswere available for future share repurchases under the May 2025 Repurchase Program.

Reworded

As a public company, we are required to comply with the Sarbanes-Oxley Act and the related rules and regulations of the SEC, including expanded disclosures and accelerated reporting requirements and more complex accounting rules. Pursuant to Section 404, we are required to, among other things, file a report by our management on our internal control over financial reporting, including an attestation report on internal control over financial reporting issued by our independent registered public accounting firm. While we were able to determine that our disclosure controls and procedures and internal control over financial reporting were effective as of MarchJune 31,30, 2026, we anticipate that we will continue to expend resources, including accounting-related costs and significant management oversight to continue to improve our internal control over financial reporting.

Management's Discussion & Analysis (MD&A) (10-Q Part I, Item 2)

34new paragraphs
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New heading “Results of Operations”

New heading “Cash Flows for the Six Months Ended June 30, 2026 and 2025”

New heading “Sale of Lab Products Business”

New heading “Acquisition of Naveris”

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New text topics: litigation, lawsuit, class action
“Litigation settlement expenses decreased by $5.1 million, or 89%, for the six months ended June 30, 2026, compared to the same period in 2025. The decrease in litigation settlement expense was mainly due to the settlement of $5.4 million related to the Securities Class Action lawsuit and additional litigation settlement expense of $0.4 million during the six months ended June 30, 2025, which was partially offset by a $0.6 million settlement related to the Derivative Actions Lawsuit during the six months ended June 30, 2026. …”
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LitigationGain settlementon expensessale decreasedof bylab $4.8products million,business orof 89%,$113.0 formillion in the threecurrent monthsperiod ended March 31, 2026, compared toreflects the samegain period in 2025. The decrease in litigation settlement expense was mainly due toon the settlementsale of $5.4our millionlab relatedproducts to the Securities Class Action lawsuit during the three months ended March 31, 2025, which was partially offset by a $0.6 million settlement related to the Derivative Actions Lawsuit during the three months ended March 31, 2026.business. For details over the aforementioned lawsuits,sale, see Note 8,1, CommitmentsOrganization and Contingencies,Description of Business, to the unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q under the caption “LitigationSale andof Indemnificationlab Obligationsproducts business,”, which is incorporated herein by reference.
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“Cash Flows for the Six Months Ended June 30, 2026 and 2025”
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“Sale of Lab Products Business”
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“Acquisition of Naveris”
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“Results of Operations”
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We are a precision medicine company dedicated to improvingadvancing outcomescare forin transplanttransplant, patientsspecialty oncology, and advancingcell organ health.therapy. We deliver solutions designed to empower clinicians and improve patient outcomes. Our integratedportfolio solutions includespans non-invasive molecular testingtesting, forclinical heart,practice kidney,management software, AI-powered data and lunganalytics transplants; laboratory products; digital health technologies;tools, and patient support solutions thatdesigned supportto careconnect beforediagnostic insight, clinical workflow, and afterpatient transplant.engagement Weto arehelp theimprove leadingpatient provider of genomics-based information for transplant patients.outcomes.

Reworded

Our commercially available post-transplant testing services consist of AlloSure® Kidney, a donor-derived cell-free DNA, or dd-cfDNA, solution for kidney transplant patients, AlloMap® Heart, a gene expression profiling solution for heart transplant patients, AlloSure® Heart, a dd-cfDNA solution for heart transplant patients, HeartCare, the combined use of AlloMap Heart and AlloSure Heart, and AlloSure® Lung, a dd-cfDNA solution for lung transplant patients. Our commercially available specialty oncology service is NavDx®, a blood-based test that detects and monitors human papillomavirus (HPV)-mediated cancers — including head, neck, and anal cancers — from diagnosis through post-treatment molecular residual disease (MRD) surveillance. We have initiated several clinical studies to generate data on our existing and planned future testing services. From time to time, we partner with pharma and biopharma companies to use our technology and tests, often in clinical trials, to identify or screen for patients that may be appropriate candidates for their products. We also offer high-quality products in the pre-transplant space that increase the chance of successful transplants by facilitating a better match between a donor and a recipient of stem cells and organs. We also provide digital transplantand solutionspatient solutions, including clinical practice management software, data and variousanalytics offeringstools, that help transplant centers withand patient management,support outcomes quality and operational support.offerings.

Reworded

Highlights for the Three Months Ended MarchJune 31,30, 2026

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• Patient and digitalDigital solutionsSolutions revenue of $16$19 million and labLab productProduct revenue of $10$13 million, representing year-over-year growth of 33%50% and a decline of 4%,8%, respectively

Reworded

• Average revenue per test of approximately $1,660$1,720, including approximately $14$16 million in prior period revenue

Reworded

• Net income of $3$111 million, compared to net loss of $10$9 million for the firstsecond quarter of 2025

Added

• Closed the sale of the Lab Products business on June 30, recognizing a $113 million gain on sale included in operating income

Reworded

We derive our revenue from testing services, productsproduct sales, and patient and digital solutions revenues.solutions. Revenue is recorded considering a five-step revenue recognition model that includes identifying the contract with a customer, identifying the performance obligations in the contract, determining the transaction price, allocating the transaction price to the performance obligations and recognizing revenue when, or as, an entity satisfies a performance obligation.

Reworded

Our testing services revenue is derived from AlloSure Kidney, AlloMap Heart, AlloSure Heart and AlloSure Lung tests, which represented 78%76% and 77% of our total revenue for each of the three and six months ended MarchJune 31,30, 2026, respectively, and 73%72% of our total revenue for each of the three and six months ended MarchJune 31,30, 2025. Our testing services revenue depends on a number of factors, including (i) the number of tests performed; (ii) establishment of coverage policies by third-party insurers and government payers; (iii) our ability to collect from payers with whom we do not have positive coverage determination, which often requires that we pursue a case-by-case appeals process; (iv) our ability to recognize revenues on tests billed prior to the establishment of reimbursement policies, contracts or payment histories; and (v) how quickly we can successfully commercialize new product offerings.

Reworded

Our product revenue is derived primarily from sales of AlloSeq Tx, Olerup SSP and QTYPE products. Product revenue represented 10% and 9% of our total revenue for the three and six months ended MarchJune 31,30, 2026, respectively, and 14% and 13% of our total revenue for the three and six months ended MarchJune 31,30, 2025.2025, respectively. We recognize product revenue from the sale of products to end-users, distributors and strategic partners when all revenue recognition criteria are satisfied. We generally have a contract or a purchase order from a customer with the specified required terms of order, including the number of products ordered. Transaction prices are determinable and products are delivered and risk of loss passed to the customer upon either shipping or delivery, as per the terms of the agreement. There are no further performance obligations related to a contract and revenue is recognized at the point of delivery consistent with the terms of the contract or purchase order.

Added

On June 30, 2026, we completed the sale of our lab products business, which included our kitted laboratory products, to Eurobio (see Note 1 to the unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q).

Reworded

Our patient and digital solutions revenue is mainly derived from sales of our Ottr software, XynQAPI, MedActionPlan, mTilda (HLA Data Systems), TransChart and Tx Access licenses, services and SaaS agreements across the digital portfolio, as well as our pharmacy sales at The Transplant Pharmacy, or TTP. Patient and digital solutions revenue represented 14% of our total revenue for the three months ended March 31, 2026,15% and 14% of our total revenue for the three and six months ended MarchJune 31,30, 2025.2026, respectively, and 15% and 14% of our total revenue for the three and six months ended June 30, 2025, respectively.

Reworded

The Number of AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare and AlloSure Lung Tests We Receive and Report The growth of our testing services is tied to the number of AlloSure Kidney, AlloMap Heart andHeart, AlloSure Heart, HeartCare and AlloSure Lung patient samples we receive and patient results we report. We incur costs in connection with collecting and shipping all samples and a portion of the costs when we cannot ultimately issue a report. As a result, the number of patient samples received largely correlates directly to the number of patient results reported.

Reworded

Comparison of the Three Months Ended MarchJune 31,30, 2026 and 2025 (In thousands)

Removed

Testing services revenue

Reworded

Testing services revenue increased by $29.5$37.9 million, or 48%,61%, for the three months ended MarchJune 31,30, 2026, compared to the same period in 2025. The increase was primarily driven by testing services volume growth of 17% as compared to the same period in 2025. The variance between revenue growth and volume growth was primarily driven by $17.7$18.0 million of increased net collections associated with tests performed and revenue recognized in prior periods under ASC 606,606 and an increase in revenue per test, partially offset by a $3.4$2.4 million reduction in testing services revenue related to the recognition of refund reserves payable to third-party payors.payers.

Removed

Product revenue

Reworded

Product revenue decreasedincreased by $0.5$1.0 million, or 4%,8%, for the three months ended MarchJune 31,30, 2026, compared to the same period in 2025. The decreaseincrease was primarily due to lowerhigher sales of our commercial NGS-based kitted solutions.

Removed

Patient and digital solutions revenue

Reworded

Patient and digital solutions revenue increased by $4.0$6.4 million, or 33%,50%, for the three months ended MarchJune 31,30, 2026, compared to the same period in 2025. The increase was primarily driven by higher pharmacy sales and growth in our digital solutions, particularly an expanded customer base from Ottr software.

Reworded

Cost of testing services increased by $2.0$0.5 million, or 13%,3%, for the three months ended MarchJune 31,30, 2026, compared to the same period in 2025. The increase was primarily attributed to higher testing services volume, partially offset by the continuous efficiency measures to lower laboratory expenses.

Reworded

Cost of product decreased by $0.8$0.6 million, or 13%, for the three months ended MarchJune 31,30, 2026, compared to the same period in 2025. The decrease was primarily due to lower sales and improved manufacturing efficiencies and lower costs resulting from favorable pricing terms negotiated with key manufacturers.

Reworded

Cost of patient and digital solutions increased by $4.0$6.4 million, or 52%,78%, for the three months ended MarchJune 31,30, 2026, compared to the same period in 2025. The increase was primarily due to an increase in the cost of goods from our pharmacy business.

Reworded

Research and development expenses increased by $2.9$5.5 million, or 16%,33%, for the three months ended MarchJune 31,30, 2026, compared to the same period in 2025. The increase was primarily attributable to increases of $2.8$4.0 million in personnel-related costs, $0.4$0.8 million in consulting and licensing expense, partially$0.5 offsetmillion byin apartnership decreasemilestone ofexpense $0.3and $0.2 million in software-related expenses.

Reworded

Sales and marketing expenses increased by $7.4$9.2 million, or 32%,38%, for the three months ended MarchJune 31,30, 2026, compared to the same period in 2025. The increase was primarily attributable to increases of $5.4$8.7 million in personnel-related costs, $1.5$1.0 million in marketing expenses,expenses $0.7and $0.1 million in travel expenses and 0.2 million in software related expenses, partially offset by a decrease of $0.4$0.6 million in consultingstock-based expenses.compensation expense.

Reworded

General and administrative expenses increased by $7.7$13.2 million, or 34%,48%, for the three months ended MarchJune 31,30, 2026, compared to the same period in 2025. The increase was primarily attributable to increases of $2.8$5.6 million in personnel-related costs, $2.0 million in stock-based compensation expense, $1.6$5.6 million in legal and consulting expenses and $1.3$2.3 million in software-relatedstock-based compensation expense, partially offset by a decrease of $0.3 million in equipment-related costs.

Removed

Litigation settlement expense

Reworded

LitigationGain settlementon expensessale decreasedof bylab $4.8products million,business orof 89%,$113.0 formillion in the threecurrent monthsperiod ended March 31, 2026, compared toreflects the samegain period in 2025. The decrease in litigation settlement expense was mainly due toon the settlementsale of $5.4our millionlab relatedproducts to the Securities Class Action lawsuit during the three months ended March 31, 2025, which was partially offset by a $0.6 million settlement related to the Derivative Actions Lawsuit during the three months ended March 31, 2026.business. For details over the aforementioned lawsuits,sale, see Note 8,1, CommitmentsOrganization and Contingencies,Description of Business, to the unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q under the caption “LitigationSale andof Indemnificationlab Obligationsproducts business,”, which is incorporated herein by reference.

Added

Litigation settlement expenses decreased by $0.4 million, or 100%, for the three months ended June 30, 2026, compared to the same period in 2025. The decrease in litigation settlement expense was mainly due to litigation settlement expense during the three months ended June 30, 2025.

Reworded

Interest income, net decreased by $0.9$0.6 million for the three months ended MarchJune 31,30, 2026, compared to the same period in 2025, primarily due to a decreaselower average balance in cash, cash equivalents and marketable securities.

Reworded

Other (expense) income, net decreased by $0.6$0.5 million for the three months ended MarchJune 31,30, 2026, compared to the same period in 2025, primarily due to foreign exchange losses during the period.three months ended June 30, 2026.

Reworded

Income tax benefit (expense) benefit

Reworded

Income tax benefit (expense) increased by $0.1$4.0 million for the three months ended MarchJune 31,30, 2026, compared to the same period in 2025. The increase iswas primarily attributable to a changecurrent tax expense of $3.8 million recognized on the taxable gain from the sale of our lab products business, which was completed on June 30, 2026. See Note 1 and Note 11 to the unaudited condensed consolidated financial statements included elsewhere in mixedthis profitQuarterly (loss)Report acrosson jurisdictions.Form 10-Q for further information.

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Results of Operations

Reworded

CashComparison Flows forof the ThreeSix Months Ended MarchJune 31,30, 2026 and 2025

Added

Testing services revenue increased by $67.4 million, or 54%, for the six months ended June 30, 2026, compared to the same period in 2025. The increase was primarily driven by testing services volume growth of 17.3% as compared to the same period in 2025. The variance between revenue growth and volume growth was primarily driven by $35.6 million of increased net collections associated with tests performed and revenue recognized in prior periods under ASC 606 and an increase in revenue per test, partially offset by a $5.8 million reduction in testing services revenue related to the recognition of refund reserves payable to third-party payers.

Added

Product revenue increased by $0.5 million, or 2%, for the six months ended June 30, 2026, compared to the same period in 2025. The increase was primarily due to higher sales of our commercial NGS-based kitted solutions.

Added

Patient and digital solutions revenue increased by $10.4 million, or 42%, for the six months ended June 30, 2026, compared to the same period in 2025. The increase was primarily driven by higher pharmacy sales and growth in our digital solutions, particularly an expanded customer base from Ottr software.

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Cost of testing services

Added

Cost of testing services increased by $2.5 million, or 8%, for the six months ended June 30, 2026, compared to the same period in 2025. The increase was primarily attributed to higher testing services volume, partially offset by the continuous efficiency measures to lower laboratory expenses.

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Cost of product

Added

Cost of product decreased by $1.4 million, or 13%, for the six months ended June 30, 2026, compared to the same period in 2025. The decrease was primarily due to improved manufacturing efficiencies and lower costs resulting from favorable pricing terms negotiated with key manufacturers.

Added

Cost of patient and digital solutions

Added

Cost of patient and digital solutions increased by $10.4 million, or 65%, for the six months ended June 30, 2026, compared to the same period in 2025. The increase was primarily due to an increase in the cost of goods from our pharmacy business.

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Research and development

Added

Research and development expenses increased by $8.4 million, or 24%, for the six months ended June 30, 2026, compared to the same period in 2025. The increase was primarily attributable to increases of $7.0 million in personnel-related costs, $1.4 million in consulting and licensing expense and $0.5 million in software-related expenses, partially offset by a decrease of $0.5 million in partnership milestone expense.

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Sales and marketing

Added

Sales and marketing expenses increased by $16.5 million, or 35%, for the six months ended June 30, 2026, compared to the same period in 2025. The increase was primarily attributable to increases of $14.1 million in personnel-related costs, $2.4 million in marketing expenses, $0.9 million in travel expenses and $0.3 million in software related expenses, partially offset by a decrease of $1.2 million in stock-based compensation expense.

Added

General and administrative

Added

General and administrative expenses increased by $20.9 million, or 42%, for the six months ended June 30, 2026, compared to the same period in 2025. The increase was primarily attributable to increases of $9.2 million in personnel-related costs, $7.5 million in legal and consulting expenses and $4.3 million in stock-based compensation expense, partially offset by a decrease of $0.1 million in equipment-related costs.

Added

Gain on sale of lab products business of $113.0 million in the current period reflects the gain on the sale of our lab products business. For details over the aforementioned sale, see Note 1, Organization and Description of Business, to the unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q under the caption “Sale of lab products business,” which is incorporated herein by reference.

Added

Litigation settlement expenses decreased by $5.1 million, or 89%, for the six months ended June 30, 2026, compared to the same period in 2025. The decrease in litigation settlement expense was mainly due to the settlement of $5.4 million related to the Securities Class Action lawsuit and additional litigation settlement expense of $0.4 million during the six months ended June 30, 2025, which was partially offset by a $0.6 million settlement related to the Derivative Actions Lawsuit during the six months ended June 30, 2026. For details over the aforementioned lawsuits, see Note 8, Commitments and Contingencies, to the unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q under the caption “Litigation and Indemnification Obligations”, which is incorporated herein by reference.

Added

Interest income, net

Added

Interest income, net decreased by $1.5 million for the six months ended June 30, 2026, compared to the same period in 2025, primarily due to a decrease in average balance of cash, cash equivalents and marketable securities.

Added

Other (expense) income, net

Added

Other (expense) income, net decreased by $1.1 million for the six months ended June 30, 2026, compared to the same period in 2025, primarily due to foreign exchange losses during the period.

Added

Income tax (expense) benefit

Added

Income tax expense increased by $3.9 million for the six months ended June 30, 2026, compared to the same period in 2025. The increase was primarily attributable to a current tax expense of $3.8 million recognized on the taxable gain from the sale of our lab products business, which was completed on June 30, 2026. See Note 1 and Note 11 to the unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for further information.

Added

Cash Flows for the Six Months Ended June 30, 2026 and 2025

Reworded

Net cash provided by operating activities consists of net loss,income, adjusted for certain noncash items in the condensed consolidated statements of operations and changes in operating assets and liabilities.

Showing the first 60 of 80 changed paragraphs. The complete comparison will be part of Pro (coming soon). Meanwhile you can read the full text in the original filing.

CDNA insider buying and selling (Form 4)

Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 14 filings (7 insiders, 12 trade dates, 350,326 shares, about $12.4M; 10 of these filings say the sales were made under a Rule 10b5-1 trading plan). Net open-market shares: -350,326 (purchases minus sales); net value about -$12.4M.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.

Trade dateInsiderTransactionSharesPriceValueOwned afterFiling
2026-10-02Goldberg Michael
Director
Grant/award 588— —62,326 SEC
2026-10-01Novack Jeffrey Adam
Secretary and General Counsel
Shares withheld for tax 997$66.23 $66.0K105,078 SEC
2026-10-01Hanna John Walter Jr
Director, President and CEO
Shares withheld for tax 8,511$66.23 $563.7K644,937 SEC
2026-10-01Kennedy Keith
CFO & COO
Shares withheld for tax 3,018$66.23 $199.9K208,686 SEC
2026-10-01Meng Jessica
Chief Commercial Officer
Shares withheld for tax 2,619$66.23 $173.5K158,980 SEC
2026-09-12Kennedy Keith
CFO & COO
Shares withheld for tax 8,220$52.37 $430.5K211,704 SEC
2026-09-12Meng Jessica
Chief Commercial Officer
Shares withheld for tax 6,688$52.37 $350.3K161,599 SEC
2026-08-05Bickerstaff George
Director
Open-market sale 20,000$46.29 $925.8K134,061 SEC
2026-08-05Novack Jeffrey Adam
Secretary and General Counsel
Open-market sale
10b5-1 plan
2,188$46.15 $101.0K106,575 SEC
2026-08-05Novack Jeffrey Adam
Secretary and General Counsel
Open-market sale
10b5-1 plan
500$46.75 $23.4K106,075 SEC
2026-08-04Cournoyer Christine
Director
Open-market sale
10b5-1 plan
16,000$46.94 $751.0K42,943 SEC
2026-08-04Goldberg Michael
Director
Open-market sale 44,700$47.06 $2.1M61,738 SEC
2026-08-01Novack Jeffrey Adam
Secretary and General Counsel
Shares withheld for tax 2,872$47.85 $137.4K108,763 SEC
2026-07-16Hanna John Walter Jr
Director, President and CEO
Open-market sale
10b5-1 plan
68,000$39.01 $2.7M653,448 SEC
2026-07-16Hanna John Walter Jr
Director, President and CEO
Option exercise
10b5-1 plan
118,000$8.20 $967.6K771,448 SEC
2026-07-16Hanna John Walter Jr
Director, President and CEO
Open-market sale
10b5-1 plan
50,000$36.11 $1.8M721,448 SEC
2026-07-16Valantine Hannah
Director
Option exercise
10b5-1 plan
7,606$20.56 $156.4K44,292 SEC
2026-07-16Valantine Hannah
Director
Open-market sale
10b5-1 plan
100$36.55 $3.7K36,686 SEC
2026-07-16Valantine Hannah
Director
Option exercise
10b5-1 plan
5,125$7.96 $40.8K65,465 SEC
2026-07-16Valantine Hannah
Director
Option exercise
10b5-1 plan
16,048$14.19 $227.7K60,340 SEC
2026-07-16Valantine Hannah
Director
Open-market sale
10b5-1 plan
28,679$36.14 $1.0M36,786 SEC
2026-07-02Goldberg Michael
Director
Grant/award 1,746— —106,438 SEC
2026-07-01Hanna John Walter Jr
Director, President and CEO
Shares withheld for tax 8,511$29.25 $248.9K653,448 SEC
2026-07-01Novack Jeffrey Adam
Secretary and General Counsel
Shares withheld for tax 997$29.25 $29.2K111,635 SEC
2026-07-01Meng Jessica
Chief Commercial Officer
Shares withheld for tax 2,411$29.25 $70.5K168,287 SEC
2026-07-01Kennedy Keith
CFO & COO
Shares withheld for tax 2,930$29.25 $85.7K219,924 SEC
2026-06-29Hanna John Walter Jr
Director, President and CEO
Option exercise
10b5-1 plan
39,900$8.20 $327.2K701,859 SEC
2026-06-29Hanna John Walter Jr
Director, President and CEO
Open-market sale
10b5-1 plan
39,900$29.24 $1.2M661,959 SEC
2026-06-26Hanna John Walter Jr
Director, President and CEO
Option exercise
10b5-1 plan
100$8.20 $820662,059 SEC
2026-06-26Hanna John Walter Jr
Director, President and CEO
Open-market sale
10b5-1 plan
100$29.00 $2.9K661,959 SEC
2026-06-15Hanna John Walter Jr
Director, President and CEO
Option exercise
10b5-1 plan
15,676$8.20 $128.5K661,959 SEC
2026-06-15Hanna John Walter Jr
Director, President and CEO
Open-market sale
10b5-1 plan
17,683$24.03 $424.9K631,959 SEC
2026-06-15Valantine Hannah
Director
Open-market sale
10b5-1 plan
12,103$23.11 $279.7K36,686 SEC
2026-06-12Valantine Hannah
Director
Grant/award
10b5-1 plan
9,795— —48,789 SEC
2026-06-12Cournoyer Christine
Director
Grant/award
10b5-1 plan
9,795— —58,943 SEC
2026-06-12Riggsbee Richard Bryan
Director
Grant/award
10b5-1 plan
9,795— —39,312 SEC
2026-06-12Cohen Fred E
Director
Grant/award
10b5-1 plan
9,795— —165,060 SEC
2026-06-12Gunasekaran Suresh
Director
Grant/award
10b5-1 plan
9,795— —37,248 SEC
2026-06-12Bickerstaff George
Director
Grant/award
10b5-1 plan
9,795— —154,061 SEC
2026-06-12Goldberg Michael
Director
Grant/award
10b5-1 plan
9,795— —195,737 SEC
2026-06-11Hanna John Walter Jr
Director, President and CEO
Option exercise
10b5-1 plan
13,618$8.20 $111.7K646,283 SEC
2026-06-11Hanna John Walter Jr
Director, President and CEO
Open-market sale
10b5-1 plan
21,998$24.02 $528.4K649,642 SEC
2026-06-06Novack Jeffrey Adam
Secretary and General Counsel
Shares withheld for tax 1,292$21.95 $28.4K112,632 SEC
2026-06-04Hanna John Walter Jr
Director, President and CEO
Option exercise
10b5-1 plan
706$8.20 $5.8K632,665 SEC
2026-06-04Hanna John Walter Jr
Director, President and CEO
Open-market sale
10b5-1 plan
4,835$24.00 $116.0K671,640 SEC
2026-05-15Torres Arthur A
Director
Open-market sale 6,484$19.89 $129.0K38,665 SEC
2026-05-14Torres Arthur A
Director
Open-market sale 4,086$20.97 $85.7K45,149 SEC
2026-05-05Novack Jeffrey Adam
Secretary and General Counsel
Open-market sale 2,688$20.68 $55.6K113,924 SEC
2026-05-01Novack Jeffrey Adam
Secretary and General Counsel
Shares withheld for tax 2,873$21.50 $61.8K116,612 SEC
2026-04-20Kennedy Keith
CFO & COO
Grant/award 24,134— —221,548 SEC
2026-04-16Hanna John Walter Jr
Director, President and CEO
Open-market sale
10b5-1 plan
10,282$21.12 $217.2K676,475 SEC
2026-04-15Hanna John Walter Jr
Director, President and CEO
Shares withheld for tax 62,049$17.57 $1.1M686,757 SEC

Well-known investors holding CDNA (13F)

InvestorQuarterSharesReported value% of their 13FChange vs prior quarter
ARK Investment Management (Cathie Wood) Common Stock2026-06-301,953,531$55.7M0.36%Reduced 12%
Renaissance Technologies COM2026-06-301,242,959$35.4M0.05%Added 5%
D. E. Shaw & Co. COM2026-06-301,137,660$32.4M0.02%Added 30%
First Eagle Investment Management COM2026-06-30598,497$17.1M0.03%Added 4%
Two Sigma Investments COM2026-06-30401,987$11.5M0.01%Added 74%
AQR Capital Management (Cliff Asness) COM2026-06-30244,375$7.0M0.0%Reduced 30%
Citadel Advisors (Ken Griffin) COM2026-06-30106,984$3.0M0.0%Added 27%
Millennium Management (Israel Englander) COM2026-06-3073,809$2.1M0.0%New position
Gotham Asset Management (Joel Greenblatt) COM2026-06-3073,579$2.1M0.0%Reduced 18%

13F reports are filed up to 45 days after quarter end and show long U.S. equity positions only; options positions are omitted here.

Coming soon: email alerts when CDNA files, watchlists and downloadable comparisons.