Oncocyte Advances Toward FDA Submission for Transplant Rejection Test Kit
The up-and-coming precision diagnostics biotech company, Oncocyte Corporation (Nasdaq: OCX), announced significant progress toward regulatory authorization of its organ transplant rejection test kit, including central IRB approval and the upcoming activation of top U.S. transplant centers for its pivotal clinical trial.
The company has finalized its clinical trial design and secured approval from a central institutional review board (IRB), a key step that ensures trial oversight and patient safety across multiple hospital sites.
Within the next several weeks, Oncocyte expects to initiate the study at three of the top 10 transplant centers in the U.S., among others. Collectively, the transplant institutions involved in the trial represent nearly 10% of the nation’s annual transplant volume, signaling strong market interest and clinical relevance.
“The transplant community has been energized by the opportunity to bring testing in-house. Some of the largest transplant centers in the U.S. are signing up to help us get our kit to market. We are thrilled with their support,” Oncocyte CEO Josh Riggs said. “We have several milestones ahead of us that we look forward to communicating to the market.”
Oncocyte’s test detects donor-derived cell-free DNA (dd-cfDNA), a biomarker that has become widely recognized as a reliable indicator of transplant rejection. The company’s U.S. and European scientific teams have played a central role in advancing the field’s understanding of dd-cfDNA and are now focused on commercializing the technology through a market-disruptive, kit-based model.
A Transformational Opportunity for Local Testing
Oncocyte’s transplant rejection test is already validated as a laboratory-developed test and reimbursed by Medicare. The next step is obtaining FDA authorization for a kitted version that would allow hospitals and transplant centers to run the assay in their own labs. The company estimates the U.S. transplant rejection testing market is worth approximately $500 million annually, with a global addressable market exceeding $1 billion.
Today, most testing is outsourced to centralized labs. Oncocyte’s approach empowers transplant centers to bring testing in-house, generating new revenue streams and supporting more sustainable, community-based care models.
Regulatory Milestones on Track
The upcoming clinical trial represents the only study required for FDA authorization via the Class II de novo pathway, intended for Class II lower-risk medical devices. Oncocyte is also preparing for its final Q-Submission (Q-Sub) meeting with the FDA, following a collaborative and productive initial Q-Sub meeting in December 2024.
“We are pleased with the quality of the engagement we’ve had with the FDA so far and are looking forward to our final Q-Sub meeting,” said Dr. Johnson Chiang, Chief Technology Officer of Oncocyte. “This process, combined with the quality of our clinical trial, reflects the strong foundation we are building for FDA submission and authorization.”
Additionally, the company will soon announce its National Principal Investigator (NPI), a leading transplant expert, and plans to host a conference call to formally introduce this key clinical leader to the broader medical and investor communities.
About Oncocyte
Oncocyte is a pioneering diagnostics technology company whose mission is to democratize access to novel molecular diagnostic testing to improve patient outcomes. Investors may visit https://investors.oncocyte.com/ for more information.
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