OncoCyte provides update on progress toward initiating clinical trial

Oncocyte (OCX) provided an update on its substantial progress toward initiating its clinical trial, which is a major step required to obtain regulatory authorization to deliver an organ transplant rejection monitoring test kit to the market. Oncocyte has completed its clinical trial design and has received approval from a large central institutional review board, which is a committee that reviews and oversees the safety and ethics of clinical trials across multiple hospital sites. Within the coming weeks, Oncocyte expects to welcome three of the top 10 transplant centers in the United States as clinical trial participants. The U.S. transplant centers engaged in supporting Oncocyte’s clinical trial collectively represent nearly 10% of U.S. transplanted organ volume. The company values the clinical expertise and diverse patient populations that these leading transplant centers contribute to the trial. Oncocyte estimates that transplant rejection testing generates about $500M in revenue per year in the U.S., largely dominated by a few central labs. U.S. regulatory authorization of Oncocyte’s kitted test would enable transplant centers to perform this testing locally in their own labs, thus generating revenue for themselves and increasing the sustainability of local care for the community. Globally, Oncocyte estimates that the total addressable market for transplant rejection testing exceeds $1B annually. In the coming weeks, the company plans to announce the identity of its National Principal Investigator and host a conference call to introduce this key opinion leader to the medical and investor communities. Importantly, the upcoming clinical trial is the only one required to obtain FDA authorization for Oncocyte to bring its first test kit to market. For clarity, Oncocyte is pursuing a Class II de novo pathway – a regulatory route for lower-risk medical devices. Class II medical devices carry lower risk than Class III devices, which are typically life-supporting technologies. The company has already achieved CLIA validation and reimbursement of the lab-developed version of the test with Centers for Medicare & Medicaid Services. Additionally, Oncocyte also announced that in the coming weeks it expects to complete its second and final Q-Submission meeting, which is a formal process for requesting feedback from the FDA before applying for product authorization. Oncocyte’s first Q-Sub meeting in December and subsequent conversations have remained productive, featuring collaborative dialogue with FDA reviewers.