Insight Molecular Diagnostics Inc. (iMDx) is a molecular diagnostics technology company. The company’s tests are designed to help provide clarity and confidence to physicians and their patients. GraftAssureCoreTM is a clinical blood-based solid organ transplantation monitoring test. GraftAssureIQTM 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. Insight Molecular Diagnostics received a positive coverage determination from Palmetto GBA, a Medicare Administrative Contractor for the Centers for Medicare & Medicaid Services (CMS), for GraftAssureCore (formerly known as VitaGraft Kidney) in 2023.
The company’s laboratory, located in Nashville, Tenn., holds a CLIA Certificate of Accreditation from the Centers for Medicare and Medicaid Services (CMS). The company also holds clinical laboratory licenses from California and 48 other U.S. states. Insight Molecular Diagnostics was formerly known as Oncocyte Corp. and was incorporated in 2009. In June 2025, it changed its company name and moved its headquarters from Irvine, Calif., to Nashville.
