Core Viewpoint - Oncocyte Corp. is making significant progress towards initiating a clinical trial for an organ transplant rejection monitoring test kit, which is essential for obtaining regulatory authorization to market the product [1][6]. Company Progress - Oncocyte has completed the clinical trial design and received approval from a central institutional review board (IRB) [2]. - The company expects to include three of the top 10 transplant centers in the U.S. as participants in the clinical trial, representing nearly 10% of the U.S. transplanted organ volume [3]. - Oncocyte estimates that transplant rejection testing generates approximately $500 million in annual revenue in the U.S., with a global addressable market exceeding $1 billion [4]. Market Engagement - The transplant community is enthusiastic about the opportunity to conduct testing in-house, with major transplant centers supporting Oncocyte's efforts [5]. - Oncocyte plans to announce its National Principal Investigator (NPI) soon and will host a conference call to introduce this key opinion leader [5]. Regulatory Pathway - The upcoming clinical trial is the only requirement for FDA authorization of Oncocyte's test kit, which is being pursued through a Class II de novo pathway [6]. - Oncocyte is preparing for its second and final Q-Submission (Q-Sub) meeting with the FDA, following productive discussions in previous meetings [7][8].