IRVINE, Calif., May 30, 2024 (GLOBE NEWSWIRE) -- (Nasdaq: OCX), a precision diagnostics company, today announced that favorable data regarding its lead product VitaGraftTM Kidney was published in the . Oncocyte’s Drs.
Ekke Schuetz and Julia Beck, inventors of the technology, are among the authors of the study. VitaGraft Kidney was used to monitor graft injury in a phase 2 double-blind, placebo-controlled study ( ) of the investigational drug felzartamab, a fully human CD38 monoclonal antibody, for antibody-mediated rejection (AMR), a leading cause of kidney allograft failure. VitaGraft Kidney measures the amount of DNA in transplant patients’ blood that comes 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 study, Oncocyte’s proprietary diagnostic test using droplet-digital PCR was able to identify responders and non-responders to felzartamab, showing, “a decrease in dd-cfDNA fractions at week 12 (0.33% [0.
25−0.40] versus 0.95% [0.
37−1.63]; mean difference: −0.75%; 95% CI: −1.
41, −0.09) and week 24 (0.31% [0.
21−0.49] versus 0.82% [0.
34−2.90]).” The study points to new clinical utilities for VitaGraft Kidney beyond the Company’s of testing.
Both therapeutic efficacy and recurrence monitoring are potential new use cases for dd-cfDNA testing. Both utilities would be expected to require multiple te.