Core Insights - Oncocyte Corp. has announced a positive update regarding the pricing of its next-generation lab-developed test (LDT), GraftAssureCore, which enhances its position in the transplant rejection testing market and indicates potential growth in its estimated $1 billion total addressable market [1][6] Pricing and Reimbursement - The Centers for Medicare & Medicaid Services (CMS) has increased the reimbursement rate for GraftAssureCore to $2,753 per result, up from $2,222 for first-time testing and $1,029 for subsequent tests [2] - This new pricing aligns with existing competitive technologies and expands market appeal for future FDA-cleared kitted products at transplant centers [6] Company Strategy and Future Prospects - Oncocyte has invested significantly in improving the scalability and manufacturability of its workflow, which supports its kitted test program [3] - The new reimbursement rate establishes a benchmark for future kitted tests, such as GraftAssureDx, which is expected to be submitted for FDA review by the end of the year [3] - The company anticipates that receiving FDA authorization will enable broader adoption of its technology, allowing transplant centers to access high-quality, FDA-cleared kits with established reimbursement [4] Clinical Trials and Market Engagement - Oncocyte has received approval from a Central Institutional Review Board for its clinical trial, with final preparations underway at participating transplant centers [4] - The company expects participation from three of the top 10 U.S. transplant centers, representing nearly 10% of annual U.S. transplant volume [4] Technology and Market Position - Oncocyte's technology quantifies donor-derived cell-free DNA (dd-cfDNA), which has been established as a trusted biomarker for transplant rejection [5] - The company is rebranding its test portfolio under the GraftAssure brand, with GraftAssureCore being the new name for its previously marketed VitaGraft assay [5]

Investment Highlights - Oncocyte is taking a disruptive approach to molecular diagnostic testing by empowering local labs with kits, contrasting the central lab model[14] - The company has secured a go-to-market strategic partner and equity investment[14] - Oncocyte has a science-driven team experienced in molecular diagnostics and rapid growth[14] - The company possesses a full R&D pipeline to fuel growth and portfolio expansion over the next decade[14] - Oncocyte's IP portfolio is attractive to partners and enables value protection[14] Transplant Market - Kidney transplant patients face a 20.2% chance of developing Antibody-Mediated Rejection (AMR) within 10 years of transplant, and up to 70% of those patients will progress to graft failure[43] - The US market supports $500 million in annual revenue for Laboratory Developed Tests (LDTs), which is currently generated by competitors[79] - The global transplant testing market is currently a $1 billion Total Addressable Market (TAM) and can expand to approximately $2 billion with claims expansion[67, 79] - Global transplants are growing at approximately 9% per year[68] Oncology Market - The estimated Total Addressable Market (TAM) for oncology in the US alone is $2 billion[97, 98] - The estimated Total Addressable Market (TAM) for Copy Number Instability (CNI) in the US Market is $4 billion[101] - There are 26 million estimated annual global testing opportunities for oncology[97] - There are 78 million estimated annual global testing opportunities for Copy Number Instability (CNI)[101]