Diagnostics developer Oncocyte has announced study data showing that its monitoring assay for kidney transplant rejection significantly reduces the time to diagnosis.
The findings, published in Nephrology Dialysis Transplantation, demonstrate that Oncocyte's VitaGraft Kidney assay was able to diagnose antibody-mediated rejection (AMR) in kidney transplant recipients nearly a year ahead of standard methods.
The VitaGraft Kidney assay is a digital polymerase chain reaction test that quantifies donor-derived cell-free DNA (dd-cfDNA); the dd-cfDNA in transplant patients' blood originates from the donor organ and is a key biomarker for assessing transplant health.
In a statement, Oncocyte noted that this is the first randomized interventional study to validate any dd-cfDNA technology as a rule-in test for biopsy in a high-risk population. The trial, conducted between June 2021 and July 2023, involved 40 kidney transplant recipients with de-novo donor-specific antibody (dnDSA), a routine biomarker used in kidney transplant management. A patient who is dnDSA positive is at greater risk of AMR.
Oncocyte's proprietary dd-cfDNA technology was able to detect the onset of AMR significantly earlier in patients (median time from inclusion to diagnosis: 2.8 months) compared to the control group using standard of care (14.5 months). Earlier diagnosis and intervention in AMR can prevent irreversible damage and minimize kidney graft loss, the company noted.
Furthermore, results from studies using VitaGraft to monitor the efficacy of two new treatments to manage rejection, anti-CD38 drugs felzartamab and daratumumab, have been published earlier this year in the New England Journal of Medicine and Transplant International. Oncocyte has signed an agreement with a European biotechnology company to be the provider of dd-cfDNA testing for a phase II clinical trial for another therapeutic for rejection management.
