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CareDx Shares Spike as AlloSure Heart Transplant Test Garners Final LCD From Palmetto

NEW YORK – Shares of transplant diagnostics company CareDx's stock rose more than 11 percent in Thursday morning trading on the Nasdaq after the company said that it had received a final local coverage determination from Medicare contractor Palmetto GBA for its AlloSure Heart test.

AlloSure Heart is a donor-derived cell-free DNA (dd-cfDNA) diagnostic which can identify underlying cell injury leading to organ rejection. Palmetto GBA issued a draft local coverage determination for the test in August 2019, proposing to cover AlloSure Heart when it is used alongside CareDx's AlloMap test to assess the risk of organ rejection in heart transplant patients and to determine if they need a heart biopsy 55 days after a transplant. Palmetto said AlloSure Heart should be used in conjunction with standard clinical assessments.

CareDx also said that it hopes the final LCD for AlloSure Heart will lead to an approval of its HeartCare product, which is a combination of AlloSure Heart and AlloMap Heart. The combined use of AlloSure Heart dd-cfDNA and AlloMap Heart gene expression profiling will provide patients and doctors with a multi-modal and noninvasive solution for managing the care of transplants, the company said.

In a note to investors on Thursday, Craig Hallum analyst Alexander Nowak said CareDx could receive Medicare reimbursement for HeartCare as soon as Nov. 15, though pricing has yet to be determined. Each $100 in incremental payment for HeartCare would add about $1 million to the company's top and bottom lines, he added.

"The final decision [on coverage for HeartCare] will allow for Medicare coverage of both AlloSure Heart & AlloSure Kidney," he wrote. "Obviously AlloSure Kidney is already covered, so this new policy combines both indications within a single document. Most importantly, HeartCare is the combo of AlloMap, AlloSure, and iBox. Thus, this new coverage decision (plus the legacy AlloMap coverage decision) is the de facto coverage of HeartCare."

Overall, Nowak estimated, HeartCare reimbursement by Medicare could add up to $23 million to the firm's revenues.

CareDx's shares rose to $42.21 in Thursday morning trading.