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Item 1. Business

2026-02-25 compared with 2025-02-28 · 152 added, 109 removed, 391 unchanged (40% of the section changed)

Company Overview

CareDx is a leading precision medicine company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic solutions for transplant patients and caregivers.

We offer testing services, products, and patient and digital solutions along the pre- and post-transplant patient journey, and we are a leading provider of genomics-based information for transplant patients.

Our headquarters is located in Brisbane, California.

Our primary operations are in Brisbane, California;

Omaha, Nebraska and Stockholm, Sweden.

CareDx is a precision medicine company dedicated to improving outcomes for transplant patients and advancing organ health.

We deliver solutions designed to empower clinicians and improve patient outcomes.

The Company's integrated solutions include non-invasive molecular testing for heart, kidney, and lung transplants;

laboratory products;

digital health technologies;

and patient solutions that support care before and after transplant.

CareDx is the leading provider of genomics-based information for transplant patients.

Our headquarters is located in Brisbane, California, and we have other primary operations in Omaha, Nebraska and Stockholm, Sweden.

We were originally incorporated in Delaware in December 1998 under the name Hippocratic Engineering, Inc.

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However, we still have a tremendous opportunity to unlock growth and innovation by driving greater value for transplant patients, clinicians, our employees, and shareholders.

CareDx is differentiated in the molecular diagnostics market because we innovated the go-to-market model for a lab developed test (LDT) business.

CareDx is differentiated in the molecular diagnostics market because we innovated the go-to-market model for a laboratory developed test (LDT) business.

Many LDT genomic products, like other medical technologies, fail to achieve a significant rate of adoption because clinicians use the products selectively.

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That market dynamic makes the cost of revenue acquisition high, which, coupled with high research and development spend on new products, makes the pursuit of profitability challenging.

In fact, very few LDT lab companies have reached cash flow break even or become profitable enterprises.

In fact, very few LDT laboratory companies have reached cash flow break even or become profitable enterprises.

In contrast, we are taking the approach of serving a concentrated market of transplant centers with a portfolio of solutions to improve health outcomes.

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Our teams across the country provide staff augmentation services inside transplant centers, helping them operate efficiently.

Additionally, through our digital business, we generate multiple terabytes of data on how transplant centers operate, which we expect will drive the next wave of innovation for the company by building new products and solutions to help transplant centers operate more efficiently, do more transplants, and grow profitably.

Additionally, through our digital business, we generate multiple terabytes of data on how transplant centers operate, which we expect will drive the next wave of innovation for the company by enabling us to build new products and solutions to help transplant centers operate more efficiently, do more transplants, and grow profitably.

We believe that this combination - remaining focused on a concentrated number of transplant centers, lowering our cost of revenue acquisition by cross-selling more solutions into the same institutions, and gaining leverage on our commercial channel – forms a clear and differentiated formula for profitable growth in the molecular diagnostics market.

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Accelerate Profitable Growth

We plan to accelerate profitable growth by first focusing on cross-selling at transplant centers, with the goal of increasing the acquisition of new patients and improving patient adherence to our testing protocols.

Second, we intend to fully integrate our digital and patient solutions and lab products teams into a single go-to-market model designed to deliver comprehensive

solutions that drive loyalty and maximize customer value.

Third, we intend to focus on generating clinical evidence to gain optimal payer coverage and reimbursement for our products leading to average selling price (ASP) appreciation.

We plan to accelerate profitable growth by first focusing on solutions-selling at transplant centers, with the goal of increasing the acquisition of new patients and improving patient adherence to our testing protocols.

Second, we intend to fully integrate

our digital and patient solutions and laboratory products teams into a single go-to-market model designed to deliver comprehensive solutions that drive loyalty and maximize customer value.

Third, we intend to focus on generating clinical evidence to gain optimal payer coverage and reimbursement for our products leading to revenue per test (RPT) appreciation.

Finally, we intend to execute on our existing research and development pipeline, with the goal of generating incremental revenues from both in-line and new products that provide solutions to unmet medical needs in transplantation.

Drive Operational Excellence

A key objective of our growth strategy is to drive operational excellence to scale our organization by being more efficient rather than simply adding more resources.

This requires a review of our operational systems and processes and an investment in tools and infrastructure so that we can scale efficiently while better servicing our customers in the pursuit of growth opportunities.

Our operational effectiveness is highly dependent on having efficient processes, effective decision-making and project management, rigorous prioritization, and having the right tools to do our work efficiently.

We have four operational excellence priorities:

(1) make it easier for physicians and patients to order our tests and support our commercial go-to-market strategy;

(2) scale global operations to drive long-term, predictable margins;

(3) deploy best-in-class technology to drive operational efficiencies;

and (4) leverage clinical evidence, coding and contracting with payers to improve revenue realization per test.

A key objective of our growth strategy is to drive operational excellence, including scaling our organization efficiently while delivering a superior customer experience.

We believe that operational excellence is critical to achieving profitable growth and margin expansion.

This approach includes continual process improvement and strategic investments in enterprise applications, remote process automation, artificial intelligence, and business intelligence tools, along with investments in data security, privacy and secure communications with our patients, providers and payer community.

Define TRANSPLANT+ and expand our total addressable market

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By focusing on this initiative, we aim to pave the way to develop novel solutions that lie at the intersection of transplantation and immunology.

We believe leveraging our core scientific and technological expertise in organ transplantation will enable an expansion into adjacent markets, such as pre- and peri-transplant areas of organ assessment, precursor disease areas that often lead to organ failure (such as autoimmune disorders, renal, hepatic, cardiovascular and lung diseases, and hematologic disorders), and cancer or other medical conditions that could require cell therapy or cell transplant.

Elevate Performance Culture

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We have initiated several clinical studies to generate data on our existing and planned future testing services.

We have signed multiple biopharma research partnerships for AlloCell, a surveillance solution that monitors the level of engraftment and persistence of allogeneic cells for patients who have received cell therapy.

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 transplant solutions and various offerings that help transplant centers with patient management, outcomes quality and operational support.

Additionally, we provide digital transplant solutions and various offerings that help transplant centers with workflow and list management, outcomes quality and patient medication adhearance.

Our software solutions are currently used in over 170 transplant centers in the U.S.

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We develop and provide diagnostic testing services for solid organ transplant recipients, hematopoietic stem cell transplant recipients and recipients of cell therapies.

During 2024, we performed more than 175,000 commercial tests from our Brisbane, California laboratory.

During 2025, we performed approximately 200,000 commercial tests from our Brisbane, California laboratory.

The care of organ transplant recipients is an intense and costly effort and requires life-long surveillance and management by highly specialized clinicians and other healthcare providers.

Unsuccessful treatment of rejection can result in an additional transplant or worse, death of the patient.

Unsuccessful management of organ rejection can result in an additional transplant or worse, death of the patient.

The historical standard for transplant surveillance has been through functional tests and with invasive biopsies to identify histopathological signs of rejection.

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Finally, the interpretation of a biopsy relies on descriptive, empirically driven consensus classifications that change over time and frequently lack an etiologic basis.

There is a growing body of evidence that traditional tools do not fully address the dynamic nature of transplant and that rejection begins before clinical signs and symptoms can be observed.

Molecular rejection is an active, dynamic process and AlloSure and AlloMap provide clinicians with early indicators of injury, as well as information to risk stratify patients and prognostic insights beyond traditional tools used for surveillance like serum creatnine and Donor-Specific Antibodies (DSA).

Improved post-transplant diagnostics are necessary to achieve further gains in the long-term care and health outcomes of heart, kidney and other organ transplant recipients.

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AlloSure Heart

AlloSure Heart, our dd-cfDNA heart transplant solution, is a molecular diagnostic test intended for the early detection of heart allograft injury and rejection.

AlloSure Heart, our donor-derived cell-free DNA (dd-cfDNA) heart transplant solution, is a molecular diagnostic test intended for the early detection of heart allograft injury and rejection.

AlloSure Heart helps provide peace-of-mind that injury is unlikely when dd-cfDNA levels are low.

AlloSure Heart is validated to detect all types of clinical rejection, including antibody mediated rejection (AMR) and acute cellular mediated rejection (ACR).

AlloSure Heart was developed specifically for transplant patients and is a non-invasive blood test that analyzes SNPs selected across all 22 somatic chromosomes to detect DNA released from a patient’s heart allograft, known as donor-derived cell-free DNA (dd-cfDNA).

AlloSure Heart was developed specifically for transplant patients and is a non-invasive blood test that analyzes Single Nucleotide Polymorphisms (SNPs) selected across all 22 somatic chromosomes to detect DNA released from a patient’s heart allograft, known as dd-cfDNA.

A 2025 Surveillance HeartCare Outcomes Registry (SHORE) analysis published in JACC stated that heart failure established the largest prospective dataset on antibody‑mediated rejection in heart transplantation and validated AlloSure Heart as a highly specific biomarker for AMR, enabling more precise, context‑driven clinical decision‑making.

HeartCare combines the gene expression profiling technology of AlloMap Heart with the dd-cfDNA technology of AlloSure Heart in one surveillance solution.

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(i) AlloMap Heart – a measure of immune system status, and (ii) AlloSure Heart – a measure of graft injury.

Each HeartCare test provides our proprietary Personalized Risk Report, combining measures of immune activation and graft injury for more precise risk assessment.

The intersection of immune activation and graft injury reveals risk strata not seen with either test alone.

HeartCare provides robust information about distinct biological processes, such as immune quiescence, active injury, acute cellular rejection and antibody mediated rejection.

The International Society for Heart and Lung Transplantation, or ISHLT guidelines published online in 2022 reinforced the use of AlloMap Heart and referenced the combined use of AlloSure Heart and AlloMap Heart for surveillance purposes.

A 2024 study of the SHORE Registry published in the Journal of Heart and Lung Transplant demonstrated that patients with a dual positive HeartCare result had a statistically significantly higher odds of acute cellular rejection on biopsy than if either test alone was positive.

The SHORE is a landmark multicenter registry in heart transplant that has monitored over 2,700 transplant patients across 67 transplant centers in the United States since 2018.

Our SHORE 3 publication demonstrates that HeartCare helps identify higher-risk patients more precisely than histology or dd-cfDNA alone.

A 2025 SHORE analysis published in the Journal of Heart and Lung Transplantation showed that positive HeartCare results—elevated AlloMap and AlloSure Heart—identified heart transplant recipients at significantly higher risk for graft dysfunction and cardiovascular death, even when biopsy results appeared normal.

This analysis showed that patients with AlloMap (+) and AlloSure (+) positive results are approximately 6x more likely to have biopsy-confirmed ACR and approximately 2x more likely to experience poor outcomes than patients with AlloMap (-) and AlloSure (-) negative results.

In 2025, HeartCare expanded its indication to cover pediatric patients of all ages starting at birth.

AlloSure Kidney

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AlloSure Kidney is validated to detect all types of clinical rejection including antibody mediated rejection (ABMR) and T-cell mediated rejection (TCMR).

AlloSure testing is reported as continuous score, and the relative change value (RCV) between two independent longitudinal AlloSure tests has been validated to inform clinical decision making when indicating a high likelihood of rejection.

In June 2024, a publication in the high-impact journal Nature Medicine described the ability of AlloSure to predict rejection in numerous scenarios including subclinical rejection in stable patients.

This same publication demonstrated that elevated levels of dd-cfDNA were highly associated with the presence, activity, and severity of all types of rejection and showed its added value beyond standard of care monitoring in predicting rejection.

AlloSure Kidney was developed specifically for transplant patients and is a non-invasive blood test that analyzes SNPs selected across all 22 somatic chromosomes to detect DNA released from a patient’s kidney allograft, known as donor-derived cell-free DNA (dd-cfDNA).

As published in Nature Medicine, AlloSure is a robust predictor of severity of rejection, with multiple thresholds enabling more precise risk assessment (low risk of rejection, likely graft injury and high risk of rejection).

AlloSure testing is reported as a continuous score, and our relative change value (RCV) compares sequential tests to identify the percentage difference between them;

RCV provides further risk stratification for patients whose levels are between 0.5% and 1.0%, and an RCV of ≥ 61% suggests rejection may be occurring.

AlloSure may identify patients who do not fit the criteria for AMR but may have significant underlying injury, and AlloSure Kidney is currently the only test proven to help identify patients with microvascular inflammation (MVI) who have DSA-negative and C4d-negative.

MVI, DSA-negative and C4d-negative, has been recognized as a distinct rejection phenotype according to the Banff 2022 Classification, and is associated with a significant risk of graft failure.

A landmark 2025 study published in the American Journal of Transplantation demonstrated that AlloSure is a clinically actionable tool for kidney transplant surveillance that strongly predicted rejection, improved biopsy yield, and enabled earlier, more precise intervention.

AlloSure Plus is an artificial intelligence‑driven diagnostic platform that integrates AlloSure® dd‑cfDNA analysis with additional clinical inputs to provide a personalized assessment related to organ rejection risk in transplant recipients.

AlloSure Plus is intended to support post‑transplant surveillance and clinical evaluation in solid organ transplant patients.

In July 2025, we announced the presentation of multiple independent studies at the 2025 World Transplant Congress evaluating AlloSure Plus across solid organ transplant settings.

These presentations included data from an international, prospective study led by the Paris Transplant Group that evaluated AlloSure Plus in renal transplant recipients using biopsy‑correlated data.

HistoMap Kidney

HistoMap Kidney, our solution for kidney rejection identification and typing, is a gene expression profiling test intended to identify allograft rejection and type of rejection in kidney transplant biopsy tissue.

Biopsy is the standard of care for kidney transplant patients suspected of rejection either through molecular methods, like AlloSure Kidney, or due to signs and symptoms of rejection.

HistoMap Kidney is being developed for use on formalin-fixed tissue samples from kidney biopsy to identify rejection and rejection type to enable clinical decision-making and appropriate therapy selection.

HistoMap Kidney, our tissue‑based molecular solution intended to identify allograft rejection and type of rejection in kidney transplant biopsy tissue.

HistoMap Kidney uses gene expression profiling to characterize immune activity and rejection phenotypes, and is designed to complement histopathology by providing molecular information to enhance the clinical interpretation of biopsy results.

Biopsy is the standard of care for kidney transplant patients suspected of rejection, including patients identified through molecular surveillance methods such as AlloSure® Kidney or through clinical signs and symptoms of rejection.

HistoMap Kidney is being developed for use on formalin‑fixed kidney biopsy tissue to support rejection identification and typing, which may assist clinicians in clinical decision‑making and therapy selection.

In 2023, a HistoMap validation study was published in the journal Laboratory Investigation , demonstrating its ability to accurately identify rejection and type as antibody mediated rejection, cellular rejection, mixed rejection, or no rejection.

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AlloSure Lung helps provide peace-of-mind that injury is unlikely when dd-cfDNA levels are low.

In April of 2022, a multicenter study of 175 patients published in the Journal of Heart and Lung Transplantation demonstrated that AlloSure Lung reduced surveillance bronchoscopies by 82%, and that AlloSure Lung can identify subclinical acute lung allograft dysfunction in stable patients without clinical signs and symptoms.

AlloSure Lung was developed specifically for transplant patients and is a non-invasive blood test that analyzes SNPs selected across all 22 somatic chromosomes to detect DNA released from a patient’s lung allograft, known as donor-derived cell-free DNA (dd-cfDNA).

AlloHeme, our solution for stem cell transplantation, is an accurate and sensitive test for monitoring and early relapse detection for hematologic malignancies after allogeneic hematopoetic stem cell transplantation.

By measuring small changes in mixed chimerism, AlloHeme may detect relapse a clinically meaningful time ahead of standard methods.

In July 2021, we launched the Assessing Chimerism and Relapse of Bone marrow/HCT transplant using AlloHeme Testing (ACROBAT) study.

The ACROBAT study is a prospective, multicenter, observational cohort study to evaluate the use of AlloHeme, an NGS tool to predict post-transplant relapse in patients with allogeneic hematopoietic cell transplants, or HCT.

In April 2022, a multicenter study of 175 patients published in the Journal of Heart and Lung Transplantation demonstrated that AlloSure Lung reduced surveillance bronchoscopies by 82%, and that AlloSure Lung can identify subclinical acute lung allograft dysfunction in stable patients without clinical signs and symptoms.

AlloHeme™ is a minimally‑invasive, next‑generation sequencing (NGS)–based, and artificial intelligence‑powered monitoring test designed to predict relapse in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) following allogeneic hematopoietic cell transplant (HCT).

AlloHeme is intended to enable the detection of emerging relapse signals earlier than traditional bone marrow‑based or marker‑specific methods through a universal, ultra‑sensitive, blood‑based surveillance approach.

The Assessing Chimerism and Relapse of Bone Marrow/HCT Transplant Using AlloHeme Testing (ACROBAT) study (NCT04635384) is a prospective, multi‑center, observational trial conducted across U.S.

transplant centers to evaluate the clinical performance of AlloHeme in patients following allogeneic HCT.

The study generated pivotal clinical validation data presented at the Tandem Meeting in 2025, supporting the potential clinical value of AlloHeme in post‑transplant relapse surveillance.

AlloCell, our solution for cell therapy such as CAR-T therapy, monitors the pharmacokinetics of engraftment and persistence of cells for patients who have received allogeneic cell therapy.

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To date, we have executed multiple agreements with biopharma therapeutics companies to use AlloCell in research and clinical studies.

Laboratory Products

We access global markets through our RUO and CE-marked lab products.

We develop, manufacture, market and sell products that increase the chance of successful transplants by facilitating a better match between a solid organ or stem cell donor and a recipient, and help provide post-transplant surveillance.

Our Lab Product portfolio includes QTYPE, Olerup SSP and SBT, AlloSeq Tx, AlloSeq HCT, and AlloSeq cfDNA.

Our laboratory product portfolio includes QTYPE, Olerup SSP and SBT, AlloSeq Tx, AlloSeq HCT, and AlloSeq cfDNA.

A 2025 study published in the American Journal of Transplantation showed that AlloSeq cfDNA delivered highly accurate detection of allograft injury and rejection across multiple organ types, demonstrating strong correlation with biopsy‑proven rejection and supporting its use as a reliable, non‑invasive surveillance tool.

Distributed PCR Kits for HLA Typing

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QTYPE primarily focuses on typing where rapid typing results are required, such as for deceased donor typing.

Typing with QTYPE requires one hour compared to the up to 2-3 hours that it takes to do traditional SSP typing and the 5-7 hours that it takes with sequence-specific oligonucleotides, or SSO.

Olerup SSP is used to type HLA alleles based on the sequence specific primer, or SSP, technology.

Typing with QTYPE requires one hour compared to the up to 2-3 hours that it takes to do traditional sequence specific primer, or SSP, typing and the 5-7 hours that it takes with sequence-specific oligonucleotides, or SSO.

Olerup SSP is used to type HLA alleles based on the SSP technology.

The Olerup SSP product line comprises products for low to high-resolution HLA typing.

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We received CE mark authorization for AlloSeq cfDNA in January 2020.

Clinical uptake for AlloSeq cfDNA will be a result of multiple factors, including product-specific evidence publications, local clinical education, customer lab technical proficiency, and levels of country-specific reimbursement.

Further clinical uptake for AlloSeq cfDNA will be a result of multiple factors, including product-specific evidence publications, local clinical education, customer laboratory technical proficiency, and levels of country-specific reimbursement.

AlloSeq HCT is an NGS solution for chimerism testing for stem cell transplant recipients.

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Patient and Digital Solutions

We provide a diverse portfolio of digital solutions to transplant centers including Ottr software, XynQAPI software, XynCare, AlloCare, AlloHome, TxAccess, MedAction Plan, The Transplant Pharmacy, or TTP, HLA Data Systems and MediGO.

We deliver an ecosystem of tailored transplant management solutions designed to help centers grow volume, improve patient outcomes, drive efficiency and ease staff workload through:

smarter referral management;

personalized patient adherence and monitoring;

streamlined operational workflows;

quality insights and clinical intelligence;

and supporting patients, clinicians, and centers across the entire transplant journey.

Workflow Solutions:

Our Ottr software consists of two unique offerings, Ottr Organ and Ottr Cellular, which provide comprehensive solutions for transplant patient management and enable integration with electronic medical records, or EMR, systems, including Cerner and Epic, providing patient surveillance management tools and outcomes data to transplant centers.

Referral Management:

TxAccess is a cloud-based service that allows nephrologists and dialysis centers to electronically submit referrals to transplant programs and closely follow and assist patients through the transplant waitlist process, and ultimately through transplantation.

Quality Solutions:

Our XynQAPI software simplifies transplant quality tracking and Scientific Registry of Transplant Recipients reporting, and our XynCare offering includes a team of transplant assistants who maintain regular contact with patients on the waitlist to help prepare for their transplant and maintain eligibility.

AlloCare is a mobile app that provides a patient-centric resource for transplant recipients to manage medication adherence, coordinate with Patient Care Managers for AlloSure scheduling, and measure health metrics.

In 2025, we launched an IOTA module, or Increasing Organ Transplant Access, which represents an enhanced XynQAPI and is designed to project the center's performance based on the latest IOTA criteria.

Patient Adherence and Monitoring:

MedActionPlan helps centers address medication adherence challenges that increase graft‑loss risk by targeting common barriers with patient‑friendly, personalized medication management and education tools to help support better patient adherence.

Our CareDx pharmacy supports patients’ medication management with expert transplant pharmacists with specialized knowledge who support patient adherence through dedicated care teams, proactive refill support and personalized, and dosed packaging.

AlloHome is a remote patient monitoring solution designed to drive patient engagement and timely interventions for patients pre- and post-transplant.

MedActionPlan provides medication safety, medication adherence and patient education.

MedActionPlan is a leader in patient medication management for transplant patients and beyond.

Lab Products Solutions:

Our HLA Data Systems software solutions, which include mTilda, VxMatch and VECTR, provide software and interoperability solutions for the histocompatibility and immunogenetics community.

Our MediGO solution provides access to donated organs by digitally transforming donation and transplantation workflows to increase organ utilization.

TTP consists of transplant-focused pharmacies located in Mississippi.

TTP provides individualized transplant pharmacy services for patients at multiple transplant centers located throughout the U.S.

Reimbursement

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We are reimbursed by Medicare for AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare and AlloSure Lung tests.

Tests performed on patients covered by Medicare represented 26%, 27% and 34% of all tests in 2024, 2023 and 2022, respectively.

Tests performed on patients covered by Medicare represented 25%, 26% and 27% of all tests in 2025, 2024 and 2023,

respectively.

Approximately 46%, 50% and 53% of all testing services revenue was derived from Medicare for the years ended December 31, 2025, 2024 and 2023, respectively.

AlloSure Kidney has been a covered service for Medicare beneficiaries since October 2017 through a Local Coverage Determination, or LCD, first issued by Palmetto MolDX, or MolDX, which was formed to identify and establish coverage and reimbursement for molecular diagnostics tests, and then adopted by Noridian Healthcare Solutions, our Medicare Administrative Contractor (MAC), or Noridian.

The Medicare reimbursement rate for AlloSure Kidney is currently $2,841.

The Medicare reimbursement rate for AlloSure Kidney is $2,753, effective January 1, 2026 .

On August 10, 2023, MolDX and Noridian released a draft proposed revision to the LCD (DL38568, Palmetto;

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and for evaluation of the adequacy of immunosuppression.

On August 10, 2023, MolDX and Noridian released a draft proposed revision to the LCD (DL38568, Palmetto;

DL38629, Noridian) that, if adopted, would have revised the existing foundational LCD, MolDX:

Molecular Testing for Solid Organ Allograft Rejection (L38568 and L38629).

On August 16, 2024, the Centers for Medicare and Medicaid Services, or 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 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 December 30, 2024, we received a CPT code (0540U) for our AlloSure tests:

AlloSure Kidney, AlloSure Heart and AlloSure Lung, which subjects such tests to a repricing process.

In June 2025, we recommended that CMS cross-walk our AlloSure tests to 0493U, another dd-cfDNA test already priced on the Medicare Fee Schedule at $2,753.

On November 25, 2025 CMS issued a final determination to cross-walk AlloSure (0540U) to CPT code 0493U.

The new reimbursement rate represents an $88 decrease to the previous pricing for our AlloSure Kidney test, and no change to the current pricing for AlloSure Heart and AlloSure Lung tests.

AlloSure, PLA Code 0540U, was listed on the Clinical Laboratory Fee Schedule effective January 1, 2026 at approximately $2,753.

On July 17, 2025, MolDX and Noridian released a new Proposed Draft foundational LCD (DL40058, DL40060) for Solid Organ Allograft Rejection testing with a revised accompanying billing article (DA60146, DA60152).

The Proposed LCD introduced new coverage criteria, utilization limitations, and a new bundled payment concept for certain CareDx testing in a “surveillance” setting, which could lead to fewer surveillance tests being reimbursed.

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 Draft 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.

AlloMap Heart has been a covered service for Medicare beneficiaries since January 2006.

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We are reimbursed for a substantial portion of the AlloMap Heart tests we perform on patients covered by private payers.

Coverage policies approving AlloMap Heart have approached nearly 90% of all covered lives and are published by many of the largest private payers, including Blue Cross Blue Shield, or BCBS payers as well as national payers.

For all tests performed outside the scope of the payer’s policy, and for tests performed where the payer has not adopted a coverage policy, we pursue reimbursement on a case-by-case basis.

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and Qiagen N.V., which supplies us with a proprietary buffer reagent.

Lab Products Manufacturing

Laboratory Products Manufacturing

We have historically purchased many of the components and raw materials used in our product kits from numerous suppliers worldwide.

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We have worked closely with our suppliers to develop alternate backup plans to ensure continuity of supply while maintaining high quality and reliability, and in some cases, we have established long-term supply contracts with our suppliers.

Due to the high standards and FDA requirements applicable to the manufacturing of our products, we may not be able to quickly establish additional or replacement sources for certain components or materials.

Due to the high standards and ISO/FDA requirements applicable to the manufacturing of our products, we may not be able to quickly establish additional or replacement sources for certain components or materials.

In the event that we are unable to obtain sufficient quantities of raw materials or components on commercially reasonable terms or in a timely manner, our ability to manufacture our products on a timely and cost-competitive basis may be compromised, which may have a material adverse effect on our business, financial condition and results of operations.

Our manufacturing facility in Stockholm, Sweden is used to support the production, packaging and labeling of our proprietary test kits:

Olerup SSP, QTYPE, AlloSeq cfDNA and HCT.

Olerup SSP, QTYPE, AlloSeq Tx, AlloSeq cfDNA and HCT.

The facility has a certified Quality Management System, or QMS, to the ISO 13485:

2016 standard.

2016 standard and country specific MDSAP requirements.

This standard includes a special set of requirements specifically related to the supply of medical devices and related services.

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Recertification is required every three years and we have been successfully recertified since obtaining our original ISO certification.

The facility maintains a valid EC certificate for compliance to Directive 98/79/EC Annex IV, excluding Sections 4 and 6, Full Quality Assurance System In Vitro Diagnostic Medical Devices.

The facility maintains valid EC certificates for compliance to Directive 98/79/EC Annex IV, excluding Sections 4 and 6, Full Quality Assurance System In Vitro Diagnostic Medical Devices and to IVDR (EU) 2017/746 under Annex IX Chapters I and III.

Annual surveillance audits are also conducted by the site’s notified body to ensure ongoing compliance.

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Each region consists of multiple territory account managers responsible for specific transplant centers.

Each region is also supported by the dedicated expertise of individuals that specialize in our digital products, lab products, and clinical experts in medical science liaisons.

This model establishes accountability at the transplant center and regional level for the total revenue generated from our transplant solutions.

The territory account manager serves as the primary point of contact for each transplant center and has a deep understanding the center’s transplant program objectives.

And by deeply understand each center’s objectives we are able to deploy the right resources and solutions to support our customers.

Each region is also supported by the dedicated expertise of individuals that specialize in our digital products, laboratory products, and clinical experts in medical science liaisons.

Outside of the U.S.

we similarly have regional structure that includes country managers in Western Europe, and distributors we work with outside of Western Europe to service the needs of our transplant center customers globally.

With our comprehensive portfolio of surveillance testing services, diagnostic products and patient and digital solutions business offerings, we face many different types of competition.

With our comprehensive portfolio of surveillance testing services, diagnostic products and patient and digital solutions business offerings, we face different types of competition.

Testing Services

Our competition principally includes clinical reference labs and hospital labs using existing and routine clinical chemistry tests and biopsies.

Our competition principally includes clinical reference laboratories and hospital laboratories using existing and routine clinical chemistry tests and biopsies.

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, Inc., or Natera, and Eurofins Transplant Genomics, Inc., or Eurofins, Devyser Diagnostics AB, or Devyser, and Oncocyte Corporation, or Oncocyte, have commercially available molecular diagnostics tests .

In the field of post-transplant surveillance, Natera, Inc., or Natera, and Eurofins Transplant Genomics, Inc., or Eurofins, Devyser Diagnostics AB, or Devyser, and Insight Molecular Diagnostics, Inc, or iMDx, have commercially available molecular diagnostics tests .

We expect the competition for post-transplant surveillance to increase as there are several established and early-stage companies in the process of developing products and services for the transplant market that may directly or indirectly compete with AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare, AlloSure Lung, or our development pipeline.

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Thermo Fisher, Omixon, GenDx, BAG, Qiagen, and Immucor.

We also face competition from hospital and commercial reference labs that develop their own in-house testing solutions.

believe that our product line competes favorably with Thermo Fisher as a leading supplier of HLA test kits based on performance, reputation and service.

We also face competition from hospital and commercial reference laboratories that develop their own in-house testing solutions.

We believe that our product line competes favorably with Thermo Fisher as a leading supplier of HLA test kits based on performance, reputation and service.

We expect future competition for post-transplant surveillance kitted solutions for AlloSeq cfDNA and AlloSeq HCT.

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Our primary competitor for our patient management EMR solution is Phoenix, Epic's transplant application.

Our referral application has two known competitors in T-REX and MedSleuth.

Our referral application has two known competitors:

T-REX and MedSleuth.

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.

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As of December 31, 2025, we had seven U.S.

patents related to diagnosing transplant rejection and autoimmune disease, which will expire between October 2025 and May 2035.

In addition, we had three 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.

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The FDA regulates the design, testing, development, manufacture, safety, labeling, marketing, promotion, storage, sale and distribution of medical devices pursuant to its authority under the Federal Food, Drug and Cosmetic Act, or FFDCA.

These regulations apply to all of our products sold in the United States, as well as our facilities in Stockholm, Sweden, used to produce some of our products.

regulations apply to all of our products sold in the United States, as well as our facilities in Stockholm, Sweden, used to produce some of our products.

The FDA has also asserted that it has the authority to regulate laboratory-developed tests, or LDTs, as medical devices under the FFDCA.

An LDT is a test developed by a single laboratory for use only in that laboratory, such as our testing services, AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare and AlloSure Lung.

The FDA has traditionally chosen not to exercise its authority to regulate LDTs because it regulates the primary components in most laboratory-developed tests and because laboratories, such as ours, certified as high complexity under the CLIA are regulated and reviewed by CMS to ensure that lab expertise and test procedures and correct analyses are followed.

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.

For AlloSure Kidney and other similar testing solutions, if required by the FDA or if new laws are enacted, we may be required to conduct additional analytical studies and clinical trials to demonstrate clinical validity and safety and effectiveness of our tests, and submit to the FDA a premarket approval application, or PMA, or 510(k) premarket notification application.

We would need to obtain FDA approval or clearance for any existing tests currently offered as LDTs, and subsequent to commercialization of any new tests.

The FDA has traditionally chosen not to exercise its authority to regulate LDTs because it regulates the primary components in most laboratory-developed tests and because laboratories, such as ours, certified as high complexity under the CLIA are regulated and reviewed by CMS to ensure that laboratory expertise and test procedures and correct analyses are followed.

In April 2025, the U.S.

District Court for the Eastern District of Texas vacated the FDA’s 2024 final rule under which the FDA intended to provide greater oversight of LDTs.

In connection with this, the FDA proposed a rule that would amend its regulations to classify vitro diagnostic products as “medical devices” under the Federal Food, Drug and Cosmetic Act.

The Court 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 limiting the FDA’s authority over our testing services.

Health Insurance Portability and Accountability Act

Under the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, the U.S.

Department of Health and Human Services, or HHS, has issued regulations to protect the privacy and security of protected health information and standardize data content, codes and formats used in healthcare transactions and the standardized identifiers used by healthcare providers, such as us, and health plans.

Under the federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, collectively, HIPAA, the U.S.

Department of Health and Human Services, or HHS, has issued regulations to protect the privacy and security of protected health information, or PHI, and standardize data content, codes and formats used in healthcare transactions and the standardized identifiers used by healthcare providers, such as us, and health plans.

We have developed policies and procedures in view of these regulations.

The requirements under these regulations may change periodically and could have an effect on our business operations if compliance becomes substantially more costly than under current requirements, business practices change or a significant breach to protected health information, or PHI, occurs.

In addition to federal privacy regulations, there are a number of state laws governing confidentiality of health information that are applicable to our operations.

In addition to federal privacy regulations, there are a number of state laws governing the confidentiality of health information that are applicable to our operations.

New laws governing privacy may be adopted in the future as well.

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The Affordable Care Act expands the government’s investigative and enforcement authority and increases the penalties for fraud and abuse, including amendments to both the Anti-Kickback Statute and the False Claims Act, to make it easier to bring a suit under these statutes.

The Affordable Care Act also allocates additional resources and tools for the government to police healthcare fraud, with expanded subpoena power for HHS, additional funding to investigate fraud and abuse across the healthcare system and expanded use of recovery audit contractors for enforcement.

The Affordable Care Act also allocates additional resources and tools for the government to police healthcare fraud, with

expanded subpoena power for HHS, additional funding to investigate fraud and abuse across the healthcare system and expanded use of recovery audit contractors for enforcement.

There have previously been public announcements by President Trump and members of the U.S.

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Department of Health and Human Services Office of Inspector General has the authority to impose such penalties and the final rule relating to such developers went into effect in August 2023.

Department of Health and Human Services Office of Inspector General began investigating health care providers for information blocking beginning on July 31, 2024, and declared it would exercise its enforcement discretion in relation to any determinations regarding conduct that occurred prior to July 31, 2024.

Anti-Kickback Statutes

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State Privacy Laws

state privacy laws, such as the California Consumer Privacy Act, or the CCPA, which took effect in January 2020, and was amended by the California Privacy Rights Act, or the CPRA, effective January 2023, secure new privacy rights for consumers and impose new obligations on us.

Other states have similarly adopted privacy laws which took effect in 2023, including

Virginia, Colorado, Utah and Connecticut.

Additionally, Delaware, Indiana, Iowa, Montana, Oregon, Tennessee and Texas also adopted privacy laws, which take effect from July 1, 2024 through 2026.

state comprehensive consumer privacy laws, such as the California Consumer Privacy Act, or the CCPA, secure privacy rights for consumers and impose obligations on us, including providing specific disclosures in privacy notices and affording consumers with certain rights concerning their personal data.

Over a third of U.S.

states have similarly adopted comprehensive consumer privacy laws and similar laws are being considered in several other states, as well as at the federal and local levels.

Our business or financial results may be adversely impacted by adhering to these regulatory requirements and the related costs of ensuring and maintaining compliance.

In addition, we cannot predict how future regulatory conditions will affect our business and may also have an adverse impact on our results of operations or financial condition.

Our business or financial results may be adversely impacted by adhering to these regulatory requirements and the related costs of ensuring and maintaining compliance.

In addition, we cannot predict how future regulatory conditions will affect our business and may also have an adverse impact on our results of operations or financial condition.

Foreign Jurisdictions

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The certification for our products under the IVDR is in progress with our notified body and certification of these products to the IVDR shall be achieved within the transition timeframes.

We are also actively working with our notified body to bring the quality management system at the sites to be compliant with IVDR requirements by May 2025.

We also worked with our notified body to bring the quality management system at the sites to be compliant with IVDR requirements.

Certain of our products also comply with the CMDCAS, which is a system designed to implement Canadian regulations requiring some medical devices be designed and manufactured under a registered QMS.

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GDPR and UK GDPR

The General Data Protection Regulation (EU) 2016/679, or the GDPR, is a regulation on data protection and privacy in the EU, and the European Economic Area, or the EEA, that went into effect in May 2018.

The General Data Protection Regulation (EU) 2016/679, or the GDPR, is a regulation on data protection and privacy in the EU, and the European Economic Area, or the EEA.

It also addresses the transfer of personal data outside the EU and EEA.

The GDPR aims primarily to give control to individuals over their personal data and to simplify the regulatory environment for international business by unifying the regulation within the EU.

The regulation contains provisions and requirements related to the processing of personal data of individuals, or data subjects, who reside in the EEA, and applies to any enterprise—regardless of its location and the data subjects' citizenship or residence—that is processing the personal information of data subjects inside the EEA.

Following the United Kingdom’s exit from the EU, the United Kingdom adopted the Data Protection Act 2018, which is the United Kingdom’s implementation of the GDPR, or the UK GDPR.

The UK GDPR imposes similar requirements for personal data about United Kingdom data subjects.

Controllers and processors of personal data must put in place appropriate technical and organizational measures to implement the data protection principles.

Business processes that handle personal data must be designed and built with consideration of the GDPR and UK GDPR principles and provide safeguards to protect data.

The regulation contains provisions and requirements related to the processing of personal data of individuals, or data subjects, who reside in the EEA, and applies to any enterprise—regardless of its location—that is processing the personal data of data subjects inside the EEA.

The UK GDPR imposes similar requirements for personal data about United Kingdom, or UK, data subjects.

Controllers and processors of EEA and UK personal data must have a legal basis to process personal data and put in place appropriate technical and organizational measures to implement the data protection principles.

Business processes that handle personal data must be designed and built with consideration of the GDPR and UK GDPR principles and provide safeguards to protect personal data.

Data controllers and processors must design information systems with privacy in mind.

No personal data may be processed unless it is done under one of six lawful bases specified by the regulation (consent, contract, public interest, vital interest, legitimate interest or legal requirement).

When the processing is based on consent, the data subject has the right to revoke it at any time.

Data controllers and processors must clearly disclose any data collection, declare the lawful basis and purpose for data processing, and state how long data is being retained and if it is being shared with any third parties or outside of the EEA, or, in the case of the UK GDPR, outside of the UK.

Data subjects have the right to request a portable copy of the data collected by a data controller or processor in a common format, and, under certain circumstances, the right to have their data erased.

Businesses must report data breaches to national supervisory authorities within 72 hours after becoming aware of the breach if they have an adverse effect on user privacy.

In some cases, violators of the GDPR or UK GDPR may be fined up to €20 million or up to 4% of the annual worldwide turnover of the preceding financial year in case of an enterprise, whichever is greater.

Violators of the GDPR or UK GDPR may be fined up to €20 million (£17.5 million in the UK) or up to 4% of the annual worldwide turnover of the preceding financial year, whichever is greater.

Our business or financial results may be adversely impacted by adhering to these regulatory requirements and the related costs of ensuring and maintaining compliance .

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We had 145 employees in manufacturing operations and support, 186 in research and development, 252 in sales and marketing and 182 in general and administrative positions.

As of December 31, 2024, 589 employees were located in the United States and 61 were located outside of the United States.

As of December 31, 2025, 706 employees were located in the U.S.

and 59 were located outside of the U.S.

The diagnostics industry is characterized by rapid product development and technological advances, which require an adept and skilled workforce.

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In addition, we believe it is important to have regular engagement with our employees to understand their needs.

Apart from regular weekly meetings with managers, monthly town hall meetings and quarterly earnings reports and calls, we also conduct annual anonymous employee surveys to understand current employee sentiment, areas we are excelling in as well as areas for improvement.

Apart from regular scheduled meetings with managers, monthly town hall meetings and quarterly earnings reports and calls, we also conduct annual anonymous employee surveys to understand current employee sentiment, areas we are excelling in as well as areas for improvement.

Our total compensation for employees includes a variety of components that support sustainable employment and the ability to build a strong financial future, including competitive market-based pay and comprehensive benefits.

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Through our global pay philosophy, principles and consistent implementation, we are committed to providing fair and equitable pay for employees.

Eligible full-time employees in the United States also have access to medical, dental, and vision plans;

Eligible full-time employees in the U.S.

also have access to medical, dental, and vision plans;

savings and retirement plans;

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and other resources.

Programs and benefits differ internationally for a variety of reasons, such as local legal requirements, market practices, and negotiations with works councils and other employee representative bodies.

Programs and benefits differ internationally for a variety of reasons, such as local legal requirements, market practices, and negotiations with employee representative bodies.

From time to time, we also employ independent contractors, consultants and temporary employees to support our operations.

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Our operations require the use of hazardous materials (including biological materials), which subjects us to a variety of federal, state and local environmental and safety laws and regulations.

Some of these regulations provide for strict liability, or holding a party potentially liable without regard to fault or negligence.

Some of these regulations provide for strict liability, or holding a

party potentially liable without regard to fault or negligence.

We could be held liable for damages and fines as a result of our, or others', business operations should contamination of the environment or individual exposure to hazardous substances occur.

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In addition, we look for ways to minimize our impact on the environment.

Our main buildings headquartered in California are energy efficiency certified and meet stringent San Francisco Bay Area requirements for environmental impact, and several of

our offices are in new energy efficient buildings.

Our main buildings headquartered in California are energy efficiency certified and meet stringent San Francisco Bay Area requirements for environmental impact, and several of our offices are in new energy efficient buildings.

Our offices also provide recycling and use low flow fixtures to conserve water, and we take additional measures to conserve energy through LED fixtures, light timers/sensors, and thermostat regulation.

6 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business