Insight Molecular Diagnostics Inc. (iMDx)

Insight Molecular Diagnostics Inc., also known as iMDx, is a pioneering diagnostics technology company dedicated to democratizing access to novel molecular diagnostic testing to enhance patient outcomes. The company's mission is to help the healthcare industry realize the potential of precision medicine. Headquartered in Nashville, Tennessee, iMDx operates globally, with a strategic focus on the rapidly growing fields of transplant and oncology.

iMDx's core business revolves around its flagship technology, which quantifies a molecular biomarker known as donor-derived cell-free DNA (dd-cfDNA). Key products include the GraftAssure family of tests, comprising GraftAssureCore for clinical solid organ transplantation monitoring, GraftAssureIQ for research use only, and GraftAssureDx, an in-vitro diagnostic test kit currently undergoing regulatory review. The company also develops oncology-focused products such as DetermaIO, a gene expression test for immunotherapy response, and DetermaCNI, a blood-based monitoring tool for cancer treatment efficacy. iMDx collaborates with Bio-Rad Laboratories, Inc. for the development and commercialization of kitted transplant products.

Led by CEO Josh Riggs, who was appointed in December 2022, Insight Molecular Diagnostics Inc. has recently achieved several notable milestones. The company submitted its GraftAssureDx product for FDA de novo review on March 25, 2026, anticipating authorization within the year. In February 2026, iMDx secured $26 million in financing and received TÜV SÜD ISO 13485 certification, with U.K. CE marking expected in Q2 2026. The company, formerly known as Oncocyte Corporation, rebranded and relocated its headquarters to Nashville, Tennessee, in June 2025, reflecting its expanded strategic direction in transplant medicine and oncology.