Oncocyte Corporation (Nasdaq: OCX) is preparing to launch a pivotal clinical trial for its organ transplant rejection monitoring test kit, having secured IRB approval and the participation of three major U.S. transplant centers representing nearly 10% of the national transplant volume. The company is also finalizing its second Q-Submission meeting with the FDA. This trial is the final step required for FDA authorization of Oncocyte’s test kit, paving the way for commercialization.
This development represents a significant advancement in transplant medicine. By enabling local testing, Oncocyte’s kit could revolutionize the $500 million U.S. transplant rejection testing market, currently dominated by centralized labs. Decentralizing this testing empowers transplant centers to generate revenue, bolstering their financial sustainability and potentially improving patient access to timely, crucial diagnostics. This shift in testing dynamics also positions Oncocyte as a key player in the larger, $1 billion global market.
The trial is designed as a Class II •de novo• pathway for lower-risk medical devices. Oncocyte previously secured CLIA validation and CMS reimbursement for the lab-developed version of the test. The upcoming trial will validate the kitted version. A final Q-Submission meeting with the FDA is imminent, building on productive prior discussions. The company plans to announce its National Principal Investigator, a leading transplant specialist, in the coming weeks.
Successfully completing this clinical trial and obtaining FDA authorization will be transformative for Oncocyte. It will unlock access to a substantial market opportunity and position the company as a leader in decentralized transplant rejection monitoring. This will likely have broader implications for the transplant industry, potentially leading to improved patient care and enhanced financial stability for transplant centers.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
