CareDx, Inc

CareDx Announces Third Quarter 2026 Financial Results

CareDx reported Q3 2026 revenue of $139 million, up 39% year-over-year, with Testing Services revenue up 65% to $119 million and volume of roughly 75,900 tests. GAAP net income was $19 million versus $2 million a year ago, with diluted EPS of $0.35, and Adjusted EBITDA doubled to $30 million on a 22% margin. The company raised FY2026 guidance to $520-$530 million in revenue (from $490-$500 million) and $90-$100 million in Adjusted EBITDA (from $66-$78 million). Growth includes the $160 million Naveris acquisition (closed July 1, 2026), while AlloHeme and HistoMap Kidney target 2027 commercial launches.

•3d ago

CareDx Announces New KOAR Data Linking Elevated AlloSure® Kidney to Nearly 3-Fold Higher Risk of Adverse Graft Outcomes in Patients with Borderline Rejection or TCMR at ASN Kidney Week 2026

CareDx presented new AlloSure Kidney data at ASN Kidney Week 2026, headlined by a KOAR registry analysis showing dd-cfDNA levels ≥1% were linked to a nearly 3-fold higher risk of allograft loss or ≥30% kidney function decline in patients with borderline rejection or TCMR (P=0.002). In a 332-patient randomized trial run by Paris Transplant Group, dd-cfDNA-guided monitoring cut biopsies by 49% with similar safety and kidney-function outcomes versus surveillance biopsy. A large validation study (4,976 recipients, 6,827 biopsies) showed AlloSure Kidney and AlloSure Plus maintained strong rejection prediction (AUC 0.833) under the updated Banff 2024 criteria, reinforcing the evidence base for the commercial product.

•10d ago

CareDx Announces Second Quarter 2026 Financial Results

CareDx reported Q2 2026 revenue of $132 million, up 52% year-over-year, driven by 61% growth in Testing Services revenue and strong demand across transplant programs. Adjusted EBITDA surged to $25 million from $5 million a year ago, reflecting improved gross profit and operational efficiency, although GAAP net income was boosted by a $113 million gain on the sale of the Lab Products business. The company raised full-year 2026 revenue guidance to $490 million-$500 million and Adjusted EBITDA guidance to $66 million-$78 million, signaling confidence in continued momentum following the finalized Medicare coverage for AlloSure and AlloMap.

•3mo ago

CareDx Announces Finalization of Solid Organ Transplant Molecular Testing Local Coverage Determination

CareDx announced the finalization of a Medicare Local Coverage Determination that affirms coverage for its solid organ transplant molecular testing portfolio across kidney, heart, and lung indications. The final policy establishes specific testing limits, allowing up to six surveillance tests in the first year for kidney patients and up to 12 tests for heart and lung patients, with four tests annually in years two and three. The policy is expected to take effect on August 30, 2026, providing important clarity and securing the reimbursement framework for the company's AlloSure and AlloMap offerings.

•3mo ago

CareDx Completes Acquisition of Naveris, Extending Leadership into High-Growth Specialty Oncology

CareDx completed its acquisition of Naveris, adding NavDx, the only Medicare-covered MRD test for HPV-positive head and neck and anal cancers. The transaction expands CareDx’s estimated addressable market to more than $12 billion; Naveris generated approximately $35 million in 2025 revenue, doubling year-over-year. NavDx has reported over 130,000 tests commercially with a $1,800 Medicare reimbursement rate, and financial consolidation begins in Q3 2026.

•4mo ago

CareDx Announces Completion of Sale of Lab Products Business to Eurobio Scientific

CareDx completed the sale of its Lab Products business to Eurobio Scientific for $171.2 million in cash, following receipt of Swedish regulatory clearance. The divested business includes IVD PCR and NGS-based kits for HLA typing and transplant monitoring assays sold outside North America. CEO John Hanna said the transaction sharpens CareDx's focus on its core U.S. Precision Medicine Testing Services and Patient and Digital Solutions, while simplifying the operating model and supporting disciplined capital allocation. The company plans to provide additional financial details, including pro forma results, during its Q2 2026 earnings call.

•4mo ago

CareDx Precision Medicine Diagnostics Showcased in Over 30 Abstracts and 9 Oral Presentations at the 2026 American Transplant Congress

CareDx announced that its precision medicine diagnostics will be featured in over 30 abstracts and 9 oral presentations at the 2026 American Transplant Congress, highlighting data from more than 110 transplant centers. Key findings in kidney transplantation suggest AlloSure is evolving into a clinical endpoint for risk assessment and treatment response, with a study of over 4,000 recipients linking persistent elevation to higher rates of rejection and graft loss. Additional data in heart and multi-organ transplantation demonstrate the predictive value of AlloMap for early immune activation and the utility of HeartCare in monitoring simultaneous heart-kidney transplant recipients.

•4mo ago

CareDx Announces Second KOAR Analysis Published in the Journal of the American Society of Nephrology

CareDx announced the publication of a second analysis from the Kidney Allograft Outcomes AlloSure Registry in the Journal of the American Society of Nephrology. The study of 1,258 patients found that AlloSure Kidney elevations were linked to a 3.7-fold and 6.4-fold higher adjusted hazard of allograft loss in intermediate and high-risk states. Management highlighted that the data support AlloSure as a noninvasive tool for longitudinal risk stratification and detecting subclinical injury before eGFR decline.

•4mo ago

CareDx Announces Dismissal of 2021 Qui Tam Suit

CareDx announced the dismissal of a qui tam action filed against the company in 2021. The dismissal was ordered by the United States District Court for the Eastern District of New York on April 23, 2026, following the qui tam plaintiff's request and the DOJ's concurrence. The DOJ had previously concluded its investigation into CareDx without any finding of wrongdoing and declined to take further action in October 2024.

•5mo ago

CareDx Announces Agreement to Acquire Naveris, A Leader in Viral-Mediated Cancer MRD Surveillance Testing

CareDx announced a definitive agreement to acquire Naveris for $160 million in upfront cash, plus up to $100 million in revenue milestones. Naveris is a commercial-stage precision oncology diagnostics company with $34 million in 2025 revenue and a proprietary blood-based test for viral-mediated cancers. The transaction is expected to be neutral to CareDx's FY2026 Adjusted EBITDA guidance and extends the company's precision medicine testing services into a $4.5 billion TAM.

•6mo ago

CareDx Announces First Quarter 2026 Financial Results

CareDx reported Q1 2026 revenue of $118 million, up 39% year-over-year, driven by a 48% increase in testing services revenue to $91 million. The company raised its full-year 2026 revenue guidance to $447M-$465M and AEBITDA guidance to $43M-$57M, signaling strong momentum. CareDx also announced the divestiture of its Lab Products business to Eurobio Scientific for $170 million and authorized a $100 million share repurchase program.

•6mo ago

CareDx Announces Presentation of More Than 50 Abstracts Including 16 Oral Presentations at the International Society for Heart and Lung Transplantation’s 46th Annual Meeting

CareDx announced the presentation of over 50 abstracts and 16 oral presentations at the ISHLT 2026 Annual Meeting, highlighting data supporting the clinical utility of its HeartCare and AlloSure Lung testing platforms. Key findings from the SHORE and ALAMO studies demonstrate the value of non-invasive molecular testing for early detection of rejection and longitudinal risk assessment, with SHORE data also linking molecular testing strategies to lower surveillance costs. The company introduced MERIT, a new randomized controlled trial designed to evaluate management strategies for heart transplant patients with abnormal molecular testing despite negative biopsy results.

•6mo ago