NEW YORK – Oncocyte announced Monday that its VitaGraft Kidney test for kidney transplant rejection has received expanded coverage from the US Centers for Medicare and Medicaid Services under the MolDx program.
The digital PCR-based assay initially received coverage under the local coverage determination for molecular testing for solid organ allograft rejection in 2023. The test can now be used to monitor patients with newly developed donor-specific antibodies for antibody-mediated rejection (AMR) using donor-derived cell-free DNA. The expanded coverage now includes the test's use for organ rejection surveillance in patients with donor-specific antibodies and focuses on high-risk patients, Oncocyte said in a statement. The expanded coverage does not extend to routine surveillance testing.
In November, Oncocyte published data in Nephrology Dialysis Transplantation showing that VitaGraft Kidney was able to diagnose AMR in kidney transplant recipients 11 months before standard protocols.
"There are currently no approved medications for managing AMR," Oncocyte CEO Josh Riggs said in a statement. "In the past year, we have supported two publications that show anti-CD38 therapies have a chance at treating the disease."
"Assuming the data continue to prove out for those drugs, catching AMR as early as possible becomes critical, highlighting the importance of this claims expansion," Riggs added. "We have now shown that you can use our test to both catch AMR early and monitor anti-CD38 therapy. Eventually, we expect to attach all these claims to our clinical kitted product that is currently in development."