BIO-RAD

Oncocyte Advances Toward Clinical Trial for Organ Transplant Rejection Test Kit

- Oncocyte has received central IRB approval for its clinical trial design and expects to enroll three of the top 10 U.S. transplant centers, representing nearly 10% of annual U.S. transplant volume. - The company is pursuing FDA authorization via a Class II de novo pathway for its donor-derived cell-free DNA (dd-cfDNA) test kit, which would enable transplant centers to perform rejection testing locally rather than through central labs. - With a final FDA Q-Sub meeting approaching and CLIA validation already achieved, Oncocyte aims to submit its data package in the second half of 2025, targeting a U.S. market estimated at $500 million annually.