Positive VitaGraft Kidney Study Results in NEJM

Oncocyte Corporation, a precision diagnostics company, has announced promising data for its lead product, VitaGraft™ Kidney, published in the New England Journal of Medicine. The data, presented by Oncocyte scientists Drs. Ekke Schuetz and Julia Beck, demonstrates the potential of VitaGraft Kidney in monitoring graft injury in a phase 2 study of felzartamab, an investigational drug for antibody-mediated rejection (AMR), a major cause of kidney allograft failure.

The study measures the amount of donor-derived cell-free DNA (dd-cfDNA) in the blood of transplant patients, an important biomarker for assessing graft health. Using Oncocyte’s droplet-digital PCR diagnostic test, the study successfully identified responders and non-responders to felzartamab. Significant decreases in dd-cfDNA fractions were observed at weeks 12 and 24, suggesting the test's potential in monitoring therapeutic efficacy and detecting disease recurrence post-treatment.

The study underscores new clinical applications for VitaGraft Kidney beyond its current approved use for cause testing. The test could be pivotal in therapeutic efficacy monitoring and recurrence detection, which would necessitate multiple tests during active treatment and long-term management phases.

Dr. Georg Böemig of the Medical University of Vienna, senior author of the publication, emphasized the assay's potential to guide dosing intervals and therapy duration, enhancing personalized treatment approaches. This is particularly significant given that up to 20.2% of kidney transplant patients develop AMR within ten years, with a substantial portion progressing to graft failure. The study suggests that the combination of felzartamab and VitaGraft Kidney testing could address this unmet need in transplant management.

Oncocyte CEO Josh Riggs expressed enthusiasm over the study’s implications, highlighting the potential to improve care and outcomes for high-risk patients. Riggs also noted the importance of Oncocyte’s partnership with Bio-Rad, which aims to support the global transplant research community with innovative dd-cfDNA monitoring tools.

The findings will be discussed at the American Transplant Congress on June 3, 2024, by Dr. Katharina Mayer from the Medical University of Vienna. Oncocyte will exhibit at the conference, showcasing their advancements in transplant diagnostics.

A conference call hosted by Oncocyte will further discuss the clinical trial results and provide an operational update, including commercial launches of VitaGraft Kidney and GraftAssure. The call will feature study authors Dr. Klemens Budde and Dr. Ekke Schuetz, who developed the dd-cfDNA technology.

Oncocyte's VitaGraft Kidney test, part of their suite of precision diagnostics, is designed to offer clarity and confidence to physicians and patients. The company’s ongoing innovations in diagnostic tests aim to improve clinical outcomes in transplant medicine and oncology, addressing significant unmet needs in these areas.