CareDx Inc. (NASDAQ:CDNA) on Thursday said Medicare has finalized the Local Coverage Determination (LCD) process for molecular testing used to monitor solid organ transplant rejection, affirming coverage across the company’s kidney, heart, and lung transplant surveillance offerings.
Following the announcement, the stock jumped nearly 29%.
The precision medicine diagnostics company said the final policy provides continued Medicare coverage for its transplant surveillance portfolio and maintains coverage for clinically indicated, for-cause testing across all three organ types.
Kidney Testing Coverage Remains In Place
Under the finalized policy, Medicare will cover surveillance testing with AlloSure Kidney for up to six tests during the first year following a transplant.
Coverage also includes up to four surveillance tests annually during the second and third years after transplantation.
CareDx noted that patients using AlloSure Kidney currently receive an average of approximately three to four tests during the first year after a transplant.
Coverage for for-cause testing remains unchanged and is available when clinically indicated.
Heart Surveillance Policy Maintained
For heart transplant recipients, Medicare will continue covering both AlloMap and AlloSure Heart. The policy also allows the two tests to be used together when medically appropriate.
The finalized coverage includes up to 12 surveillance tests during the first post-transplant year and up to four tests annually in the second and third years. Coverage for for-cause testing remains unchanged when clinically necessary.
Lung Monitoring Coverage Continues
The final Medicare policy also maintains coverage for AlloSure Lung, including up to 12 surveillance tests during the first year after transplantation and four annual tests during years two and three.
According to CareDx, these coverage criteria align with the need for frequent monitoring during the early post-transplant period for lung transplant patients.
Company Highlights Broader Transplant Focus
CareDx described itself as a precision medicine diagnostics company focused on advancing care in transplant, specialty oncology, and cell therapy.
The company said the finalized Medicare policy affirms coverage across its transplant surveillance offerings for kidney, heart, and lung recipients.
CDNA Stock Price Activity: CareDx shares were up 28.89% at $38.34 at the time of publication on Thursday, according to Benzinga Pro data.
Photo by Pavel Kapysh via Shutterstock
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