CareDx Q2 FY26 earnings call CDNA

CareDx is advancing its pipeline with Allaheem, a recurrence monitoring test for AML and MDS hematologic malignancies, which is on track for CLIA readiness by year-end 2026 and a planned 2027 commercial launch. A clinical validation manuscript for Allaheem, demonstrating its ability to predict relapse a median of 41 days before clinical diagnosis, has been submitted to a peer-reviewed journal. Additionally, HistoMAP Kidney, a molecular tissue biopsy assessment tool, showed promising new data published in Transplantation, distinguishing patients with significantly different graft loss outcomes. The company intends to launch HistoMAP Kidney in a clinical study this year and make it commercially available more broadly in 2027.

The recent acquisition of NavDx, a specialty oncology company with a solid tumor MRD platform, is progressing with encouraging momentum. CareDx is focusing its integration efforts on leveraging its commercial capabilities, workflow expertise (including Epic integration), and revenue cycle management to expand adoption and market access for NavDx. These initiatives aim to combine NavDx's differentiated technology with CareDx's established commercial reach and operational scale to drive value creation.

New data presented at the 2026 American Head and Neck Society Annual Meeting for NavDx highlighted the clinical significance of its quantitative score in predicting response to salvage therapy for HPV-driven cancers. Furthermore, 33 experts across 15 institutions published consensus recommendations supporting the use of circulating tumor HPV DNA for diagnosis and surveillance, signaling its growing establishment in clinical practice. This evidence generation strategy is crucial for building clinical confidence and supporting future adoption.

CareDx continues to strengthen its leadership in transplant diagnostics, with molecular testing increasingly integrated into clinical decision-making. Data presented at the American Transplant Congress (ATC) reinforced AlloSure Kidney's role beyond surveillance, demonstrating its utility in risk assessment, treatment response, and long-term graft outcomes. A study of over 1,100 kidney transplant recipients from the KOR Registry showed that 35% of patients with persistently elevated AlloSure levels faced a nine-fold higher risk of graft loss, emphasizing the importance of longitudinal monitoring.

A significant milestone was the finalization of the Medicare local coverage determination (LCD) for solid organ transplant molecular testing on July 16th. This policy affirms coverage for surveillance testing across kidney, heart, and lung transplants, reinforcing the role of AlloSure and AlloMap in post-transplant patient management. The policy also establishes a framework for future innovation, including a pathway for HistoMAP coverage and potential expansion into additional organs like liver transplant, acknowledging molecular diagnostics as integral to transplant management.

The divestiture of the lab products business, completed on June 30th, generated $172 million in consideration and a $113 million GAAP gain on sale ($104 million excluded from non-GAAP operating income). This strategic move improved the company's cash cycle by 70 days and significantly reduced regulatory and quality overhead associated with the kit business. CareDx ended the quarter with a strong cash position of $374 million and no debt, providing flexibility for future investments and growth initiatives.