IRVINE, CA / ACCESSWIRE / September 18, 2023 /
Oncocyte Corporation (NASDAQ:OCX), a precision diagnostics company, today announced the presentation of significant new clinical data at the European Society of Organ Transplant (ESOT) conference.
The data was generated from a randomized interventional clinical trial conducted by Charité, 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 (dd-cfDNA) assay identified antibody-mediated rejection (ABMR) 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 (3.6 +/- 3.0 vs. 14.1 +/- 1.9 months, p<0.001). 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.
"The team at Charité continues to advance the utility of dd-cfDNA testing. We congratulate them on the presentation of these data," said Josh Riggs, CEO of Oncocyte. "We expect that this study and those that follow will lead to improved patient outcomes. These data add to the growing body of evidence supporting VitaGraft's superiority over current monitoring standards to close diagnostic gaps. In addition to detecting ABMR 10 months sooner, VitaGraft can also offer fast turnaround times and absolute quantification."
VitaGraft currently is available as a research use only (RUO) 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 (CMS), confirming that the test has met the criteria for coverage reimbursement under MolDX: Molecular Testing for Solid Organ Allograft Rejection (L38568). 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.
More information about the VitaGraft Kidney Test and clinical evidence supporting its use can be found on Oncocyte's website at
oncocyte.com/vitagraft-kidney. VitaGraft Kidney is the first in a series of transplant tests in development at Oncocyte. Oncocyte's second transplant test, VitaGraft Liver, remains under review for coverage at MolDX. More information about the VitaGraft Liver Test and clinical evidence supporting its use can be found on Oncocyte's website at
oncocyte.com/vitagraft-liver.
About Oncocyte
Oncocyte is a precision diagnostics company. The Company's tests are designed to help provide clarity and confidence to physicians and their patients. VitaGraft™ is a blood-based solid organ transplantation monitoring test. DetermaIO™ is a gene expression test that assesses the tumor microenvironment to predict response to immunotherapies, and the pipeline test DetermaCNI™ is blood-based monitoring tool for assessing therapeutic efficacy. For more information, please visit:
www.oncocyte.com
DetermaIO™, DetermaCNI™, and VitaGraft™ are trademarks of Oncocyte Corporation.