OncoCyte Corp. is a molecular diagnostics company, which engages in the development and commercialization of diagnostic tests for the detection of cancer, including molecular diagnostic services to pharmaceutical customers. Its products include DetermaRx and DetermaIO. The firm also offers pharmaceutical services like multi-analyte test development and clinical trial services. The company was founded in September 2009 and is headquartered in Alameda, CA.
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- Oncocyte has received central IRB approval for its clinical trial design and expects to enroll three of the top 10 U.S. transplant centers, representing nearly 10% of annual U.S. transplant volume. - The company is pursuing FDA authorization via a Class II de novo pathway for its donor-derived cell-free DNA (dd-cfDNA) test kit, which would enable transplant centers to perform rejection testing locally rather than through central labs. - With a final FDA Q-Sub meeting approaching and CLIA validation already achieved, Oncocyte aims to submit its data package in the second half of 2025, targeting a U.S. market estimated at $500 million annually.
- Oncocyte's proprietary blood-based assay demonstrated clinical validity in monitoring kidney transplant patients for up to 13.7 years post-transplant, validating its utility for long-term patient management. - The study revealed novel correlations between donor-derived cell-free DNA (dd-cfDNA) levels and specific rejection types, finding elevated levels in T-cell mediated rejection with vascular inflammation but not in calcineurin inhibitor toxicity. - Results support expanded Medicare reimbursement coverage and strengthen the case for routine screening of high-risk transplant patients, particularly those with de novo donor-specific antibodies.
- Oncocyte is expanding the reach of its GraftAssure test, securing agreements with transplant centers representing 9% of German and 2% of U.S. transplant volumes. - The company is on track to meet its goal of having over 20 transplant centers using GraftAssure tests by the end of 2025, signaling strong commercial progress. - Oncocyte has initiated the FDA pre-submission process for its VitaGraft+ kitted test, aiming for IVD clearance to democratize transplant rejection testing. - Recent studies support the clinical value of dd-cfDNA monitoring, potentially expanding the market for Oncocyte's transplant and oncology products.
- DetermaIO, a 27-gene expression test, can identify TNBC patients likely to benefit from atezolizumab added to chemotherapy, improving pathologic complete response (pCR) rates. - In the neoTRIPaPDL1 trial, DetermaIO-positive patients had a significantly higher pCR rate (69.8%) with atezolizumab plus chemotherapy compared to chemotherapy alone (46.9%). - The test's predictive ability was validated using data from the I-SPY2 trial with pembrolizumab, showing significantly higher pCR rates in DetermaIO-positive patients. - Oncocyte is pursuing CMS reimbursement coverage to broaden access to DetermaIO, aiming to improve treatment decisions for TNBC patients.
