NEW YORK — Shares of CareDx soared 18 percent on Monday following a new position statement from the American Society of Transplant Surgeons (ASTS) endorsing the use of donor-derived, cell-free DNA (dd-cfDNA), as well as peripheral blood gene expression profiling, in organ transplant care.
According to the statement, ASTS now supports the use of dd-cfDNA as a biomarker of kidney transplant rejection, as well as peripheral blood gene expression profiling to help rule out heart transplant rejection in certain cases.
"We strongly encourage commercial payors to align reimbursement practices for molecular diagnostic testing with clinical guidelines and emerging practice patterns, as well as with Medicare beneficiary coverage patterns," the statement said.
CareDx markets AlloSure Kidney and AlloSure Heart, which are designed to measure levels of dd-cfDNA in order to predict the rejection of kidney and heart transplants, respectively. The Brisbane, California-based firm also offers AlloMap Heart, a gene expression panel that assesses immune quiescence and can be used in conjunction with AlloSure Heart.
"We applaud ASTS for their leadership in issuing a position statement on the use of dd-cfDNA for routine monitoring of allograft health in kidney, and additionally the use of dd-cfDNA and peripheral blood gene expression profiling in heart," CareDx President and CEO Reg Seeto said in a statement.
The ASTS statement comes on the heels of Palmetto MolDx updating its reimbursement guidance for molecular tests assessing rejection risk in solid organs with more restrictive language concerning appropriate use and testing frequency, which resulted in a sharp decline in CareDx's stock last week.
In Tuesday morning trading, CareDx's shares were down almost 7 percent, at $9.93, but still up more than 10 percent from last week's closing price.