- CareDx, Inc. (CDNA, Financial) announces a draft Local Coverage Determination (LCD) for solid organ transplant surveillance testing.
- The draft LCD confirms coverage for kidney, heart, and lung transplant patients without the need for protocol biopsy.
- The draft introduces a bundled payment approach for surveillance testing and is open for public comment until August 31, 2025.
CareDx, Inc. (CDNA), a precision medicine company specializing in transplant patient healthcare solutions, has announced the issuance of a proposed draft Local Coverage Determination (LCD). This draft policy emphasizes the significance of surveillance testing for early detection of allograft rejection in kidney, heart, and lung transplants.
The proposed draft, which retains existing coverage levels without necessitating protocol biopsies, highlights the critical role of non-invasive molecular testing in managing solid organ transplants. Furthermore, the draft introduces a novel bundled payment concept for surveillance testing, aligning with ongoing efforts to optimize healthcare value.
John W. Hanna, President and CEO of CareDx, expressed confidence in the draft policy, stating, "We believe publication of this draft policy solidifies coverage for surveillance testing and supports our longstanding position that our tests improve health outcomes for transplant patients." He confirmed that the company does not anticipate any alterations in test usage following this draft LCD.
The draft policy remains open for public comment until August 31, 2025, and CareDx plans to provide further insights during its earnings call on August 6, 2025. CareDx, headquartered in Brisbane, California, continues to be a leading provider in the field of genomics-based transplant patient solutions.
