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Oncocyte Company Profile

Oncocyte is a molecular diagnostics technology company. The company’s tests are designed to help provide clarity and confidence to physicians and their patients. VitaGraftTM is a clinical blood-based solid organ transplantation monitoring test. GraftAssureTM is a research use only (RUO) blood-based solid organ transplantation monitoring test. DetermaIOTM is a gene expression test that assesses the tumor microenvironment to predict response to immunotherapies. DetermaCNITM is a blood-based monitoring tool for monitoring therapeutic efficacy in cancer patients.

The company has a collaboration agreement with Bio-Rad Laboratories, Inc. (Bio-Rad) to collaborate in the development and the commercialization of research use only and in vitro diagnostics kitted transplant products using Bio-Rad's ddPCR instruments and reagents. Oncocyte received a positive coverage determination from Palmetto GBA, a Medicare Administrative Contractor for the Centers for Medicare & Medicaid Services (CMS), for VitaGraft Kidney in 2023.

Oncocyte’s laboratory, located in Nashville, TN, holds a CLIA Certificate of Accreditation from the Centers for Medicare and Medicaid Services (CMS). Oncocyte also holds clinical laboratory licenses from California and 48 other U.S. states. OncoCyte Corporation was incorporated in 2009 and is based in Irvine, California.

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