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CDNA News
CDNA Events
CareDx Finalizes Medicare Coverage Decision
CareDx announced the finalization of the Medicare Local Coverage Determination process related to molecular testing for solid organ allograft rejection. The final policy affirms coverage across CareDx's transplant surveillance offerings in kidney, heart, and lung.
CareDx Publishes Kidney Transplant Study Analysis
The company states: "CareDx announced the publication of a new analysis from the Kidney Allograft Outcomes AlloSure Registry, a landmark multi-center study, in the Journal of the American Society of Nephrology, or JASN. The second manuscript from KOAR evaluated the relationship between AlloSure Kidney donor-derived cell-free DNA and three year kidney allograft outcomes in a multi-center cohort of 1,258 adult kidney transplant recipients across 56 U.S. centers. The study applied a multistate modeling framework to assess how longitudinal changes in AlloSure dd-cfDNA levels over time relate to subsequent allograft dysfunction and graft loss. During follow-up, approximately 36% of patients experienced dd-cfDNA elevation, transitioning from low to higher-risk states and underscoring the clinical relevance of longitudinal monitoring."
CareDx Dismisses Qui Tam Action Against Company
CareDx announced the dismissal of a qui tam action filed against the Company. On April 23, 2026, the United States District Court for the Eastern District of New York issued an order dismissing the matter. There is no monetary payment associated with the dismissal. The matter was initially filed on February 12, 2021 and led to a DOJ investigation. On October 8, 2024, CareDx announced that the DOJ had concluded its investigation into CareDx without any finding of wrongdoing and declined to take further action. CareDx has denied allegations of wrongdoing throughout.
CareDx Reports Q1 Revenue of $118M
Reports Q1 revenue $118M, consensus $104.45M. "Our team delivered another quarter of record growth, driven by continued momentum in our Precision Medicine Testing Services and Patient and Digital Solutions businesses," said John W. Hanna, President and CEO of CareDx. "And we took important strategic steps advancing our lead pipeline asset, AlloHeme, and agreeing to divest the Lab Products business to simplify our operating model and create focus, with the goal of expanding our AEBITDA margins."
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