Oncocyte dd-cfDNA Assay Detects Kidney Transplant Rejection 11+ Months Ahead of Standard Protocols, New Study Affirms   By Investing.com

• Oncocyte first to published randomized interventional data to rule-in for biopsy in high-risk patient population  
• Study shows that monitoring with Oncocyte’s assay significantly reduces time to rejection diagnosis in patients with newly developed donor-specific antibodies  
• Early detection of transplant rejection is growing in significance as novel therapeutic treatments show promising early results in antibody mediated rejection.  
• Study published in Nephrology Dialysis Transplantation  

IRVINE, Calif., Dec. 02, 2024 (GLOBE NEWSWIRE) — Oncocyte Corp.,¯(Nasdaq: OCX), a diagnostics technology company, today¯announced additional favorable data regarding its lead assay VitaGraft™,¯which was published in the journal, Nephrology Dialysis Transplantation.  

VitaGraft Kidney™ quantifies the amount of DNA fragments in transplant patients’ blood that originate from the donor organ, a key biomarker for assessing graft health. This process is commonly referred to as donor-derived cell-free DNA (dd-cfDNA) testing and is widely used in clinical practice today. In this latest study, Oncocyte’s proprietary diagnostic dd-cfDNA test using digital PCR was able to diagnose antibody-mediated rejection (AMR) in kidney transplant recipients nearly a year ahead of standard protocols1.  

 We are excited to see our dd-cfDNA technology demonstrate strong predictive value for AMR, supporting clinicians in identifying AMR in patients sooner, thereby enhancing the opportunity for better outcomes, said Oncocyte Chief Science Officer Dr. Ekkehard Schuetz. The trial’s results further validate dd-cfDNA as a critical biomarker that can bridge diagnostic gaps for transplant patients.  

For further context, de-novo donor specific antibody (dnDSA) is a routine biomarker used in kidney transplant management. The appearance of dnDSA in a patient — that is, the patient is found to be dnDSA-positive (dnDSA+) — signals an increased risk of AMR. This latest study shows that compared to standard of care, VitaGraft Kidney can significantly reduce the time to diagnosis of AMR in dnDSA+ patients. It is also the first randomized interventional study to validate any dd-cfDNA technology as a rule-in test for biopsy in a high-risk population.  

Catching AMR early, when kidney graft loss can be minimized, is becoming increasingly important as physicians explore the use of drugs, including the anti-CD38 drugs felzartamab and daratumumab, to manage rejection. Monitoring with VitaGraft…