Oncocyte Corp. (Nasdaq: OCX) has made significant progress toward initiating a pivotal clinical trial for its organ transplant rejection monitoring test kit, the company announced today. The trial represents the final major step required to obtain FDA regulatory authorization for bringing the diagnostic technology to market.
The Irvine, California-based diagnostics company has completed its clinical trial design and received approval from a central institutional review board (IRB), which oversees the safety and ethics of clinical trials across multiple hospital sites. Within weeks, Oncocyte expects to welcome three of the top 10 U.S. transplant centers as trial participants, collectively representing nearly 10% of annual U.S. transplanted organ volume.
"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," said Josh Riggs, CEO of Oncocyte.
Market Opportunity and Regulatory Strategy
Oncocyte estimates the U.S. transplant rejection testing market generates approximately $500 million in annual revenue, currently dominated by a few central laboratories. Globally, the company projects the total addressable market exceeds $1 billion annually.
The company is pursuing FDA authorization through a Class II de novo pathway, a regulatory route designed for lower-risk medical devices. This approach requires only one clinical trial for market authorization, differentiating it from the more stringent requirements for Class III devices, which typically support or sustain life.
"When we announced our partnership with Bio-Rad in April 2024, it was with this moment in mind," Riggs noted. "We're building nice momentum heading into the trial and continue to target submission of our data package in the second half of this year."
Importantly, Oncocyte has already achieved CLIA validation and secured reimbursement from the Centers for Medicare & Medicaid Services (CMS) for the lab-developed version of its test.
Technology and Clinical Development
Oncocyte's diagnostic test quantifies donor-derived cell-free DNA (dd-cfDNA), a molecular biomarker that indicates potential organ rejection. The company's scientists in Germany and the United States have contributed significantly to establishing dd-cfDNA as a trusted biomarker for transplant rejection over the past decade.
Dr. Johnson Chiang, Chief Technology Officer of Oncocyte, highlighted the company's productive engagement with regulators: "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. This process, combined with the quality of our clinical trial, reflects the strong foundation we are building for FDA submission and authorization."
The company expects to complete its second and final Q-Submission meeting with the FDA in the coming weeks. This formal process allows Oncocyte to receive feedback from regulators before submitting its application for product authorization.
Decentralized Testing Approach
Oncocyte's business model aims to disrupt the current centralized testing paradigm. FDA authorization of its kitted test would enable transplant centers to perform rejection testing locally in their own laboratories, potentially generating revenue for the centers themselves while increasing the sustainability of local care.
"This approach could fundamentally change how transplant centers manage patient care by bringing critical diagnostic capabilities in-house rather than relying on external laboratories," explained Riggs.
In the coming weeks, Oncocyte plans to announce its National Principal Investigator, described as a leading transplant specialist, and will host a conference call to introduce this key opinion leader to medical and investor communities.
Clinical Impact
For transplant patients, timely detection of rejection is critical for long-term organ survival and patient outcomes. Current monitoring approaches often involve invasive biopsies or sending samples to specialized central laboratories, which can delay results.
Oncocyte's test aims to provide a less invasive, more accessible option for monitoring transplant patients, potentially enabling earlier intervention when signs of rejection are detected.
The company's technology could particularly benefit transplant centers in underserved regions by providing local access to sophisticated molecular diagnostic capabilities that are currently concentrated in a few specialized facilities.
