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Oncocyte VitaGraft Kidney Transplant Test Receives CMS Coverage

NEW YORK – Precision diagnostics company Oncocyte announced on Tuesday that its VitaGraft kidney transplant test has received Medicare coverage, following a positive decision from Medicare administrative contractor Palmetto.

The diagnostic test is based on Bio-Rad's Droplet Digital PCR and will be covered under MolDx LCD L38568: Molecular Testing for Solid Organ Allograft Rejection. This is the same LCD covering CareDx's multimodal HeartCare transplant surveillance service.

The company noted that it expects to present new interim data from an ongoing interventional kidney study at the European Society of Organ Transplantation conference, taking place in Athens, Greece, in September.

"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," Oncocyte CEO Josh Riggs said in a statement.

VitaGraft became available through an early-access program out of the Irvine, California-based company's central CLIA lab late last year. Oncocyte plans to make it broadly available once final reimbursement is settled with initial revenue from the service lab business expected to begin early next year.

The firm raised funds to develop and commercialize VitaGraft and several other offerings through a 45.6 million share stock offering in April that raised approximately $13.9 million.

A second transplant test, VitaGraft Liver, remains under review for coverage at MolDx.