Oncocyte Corporation, a precision diagnostics company, announced that Palmetto GBA, the Medicare Administrative Contractor for the Centers for Medicare & Medicaid Services (CMS), has issued a positive coverage decision for the Company’s VitaGraft Kidney diagnostic test, confirming that the test has met the criteria for coverage under MolDX: Molecular Testing for Solid Organ Allograft Rejection (L38568).

Launched via an early access program in Q3 2022, the VitaGraft Kidney blood test is designed to identify signs of graft damage in patients with clinical suspicion of rejection at least 12 days post-transplant. Kidney recipients represent the largest group of solid organ transplantations with almost 60% (~25,000) of all transplants done each year in the US and over 80% of the patients on the waiting list.

VitaGraft Kidney is the first in a series of transplant tests in development at Oncocyte. VitaGraft Kidney addresses a $1B+ estimated kidney market that is part of a $2B+ estimated overall transplant market opportunity.

“Our digital-droplet PCR workflow offers significant technical advantages over NGS workflows. We believe that this patented approach is a step in the right direction for patients and the transplant clinical community,” says Josh Riggs, Oncocyte’s CEO. “VitaGraft is supported by over a decade of published clinical data in kidney, liver and heart recipients. Our technology has repeatedly delivered reliable results with fast turnaround time, representing a significant improvement to the standard of care for at-risk patients and those under long-term management.”

Further reading: CRISPR Assay Could Help Diagnose Kidney Transplant Rejection

VitaGraft Kidney is currently available through an Early Access Program in Oncocyte’s central CLIA service lab and will be broadly available upon request once final reimbursement is established. Initial revenue from the service lab business is expected to begin in Q1 2024.

New interim data from an ongoing interventional kidney study is scheduled for presentation at the European Society of Organ Transplantation conference in September.

Oncocyte’s second transplant test, VitaGraft Liver, remains under review for coverage at MolDX.