OncoCyte presents clinical data on VitaGraft Kidney

Oncocyte announced the presentation of significant new clinical data at the European Society of Organ Transplant conference. The data was generated from a randomized interventional clinical trial conducted by Charite, a leading transplant and research institution in Germany. Interim results showed that monitoring kidney transplant patients with Oncocyte’s VitaGraft Kidney donor-derived cell-free DNA assay identified antibody-mediated rejection 10 months sooner than standard of care monitoring protocols. For DSA+ patients with ABMR, time to diagnosis was significantly shorter in the intervention group than in the control group. This is the first randomized interventional trial demonstrating the superiority of longitudinal monitoring with a dd-cfDNA assay in early identification of ABMR. The current standard of care uses kidney function tests and other biomarkers to monitor for graft health and AMBR. The data presented at ESOT show that adding longitudinal dd-cfDNA testing like VitaGraft to monitoring protocols has the potential to enable earlier intervention for kidney transplant patients. VitaGraft currently is available as a research use only assay upon request. In late August, VitaGraft Kidney received a positive coverage determination from Palmetto GBA, a Medicare Administrative Contractor for the Centers for Medicare & Medicaid Services, confirming that the test has met the criteria for coverage reimbursement under MolDX: Molecular Testing for Solid Organ Allograft Rejection. Oncocyte expects to receive pricing information within the next few weeks and to initially commercialize VitaGraft Kidney through its early access program over the next few months. Early commercial revenue from the test is expected beginning in 1H 2024, with broader commercialization in the U.S. and other countries planned to follow.