Oncocyte’s VitaGraft KidneyTM Utilized in Study Published in Peer-Reviewed Journal, Makes Use-Case for Potential Global Adoption of Test
Oncocyte Corporation’s (Nasdaq: OCX) VitaGraft TM Kidney diagnostic test for transplant monitoring has been successfully utilized in a Phase 2 clinical trial published in the peer-reviewed New England Journal of Medicine.
The study’s results point to new clinical utilities – therapeutic efficacy and recurrence monitoring – for VitaGraft Kidney, a dd-cfDNA test, which is already approved for CMS reimbursement in for-cause testing.
In the double-blind, placebo-controlled study evaluating the investigational drug, felzartamab, VitaGraft Kidney was used to monitor signs of graft damage in patients with antibody-mediated rejection (AMR), a leading cause of kidney allograft failure. The study’s results suggest that the combination of felzartamab drug therapy and VitaGraft Kidney testing may have significant potential to address this key unmet need in transplant management by enabling detection, management, and monitoring of AMR.
Josh Riggs, Oncocyte’s CEO, commented, “It is exciting to see a new opportunity for Oncocyte’s technology to serve the clinical market and patients in need. This study, combined with earlier results showing that our test can detect AMR up to 10 months earlier than protocol, points to new opportunities to improve care and outcomes for these high-risk patients. In the future, we expect that VitaGraft will be there to support physicians looking to detect AMR as early as possible and then effectively manage this disease.”
In April 2024, Oncocyte announced it would partner with Bio-Rad Laboratories (NYSE: BIO), a global leader in life science research and clinical diagnostics products, to commercialize its research use only (RUO) GraftAssure™ assay.
“Our recent partnership with Bio-Rad gives us the scale we need to support the global transplant research community with easy-to-use dd-cfDNA monitoring tools. Use cases like this will help drive adoption of our combined technology around the world,” said Mr. Riggs.
Approximately 20% of kidney transplant patients will develop AMR within 10 years of transplant, and up to 70% of those patients will progress to graft failure. Currently, there are no FDA approved drugs for the management of AMR. Oncocyte’s VitaGraft Kidney offers a fast, affordable, easy-to-use test for assessing the health of transplanted kidneys.
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 clinical blood-based solid organ transplantation monitoring test. GraftAssure™ is a research use only (RUO) blood-based solid organ transplantation monitoring test. DetermaIO™ is a gene expression test that assesses the tumor microenvironment to predict response to immunotherapies. DetermaCNI™ is a blood-based monitoring tool for monitoring therapeutic efficacy in cancer patients. For more information about Oncocyte, please visit https://oncocyte.com/.
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