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Insight Molecular Diagnostics Inc.

Insight Molecular Diagnostics Inc. is a precision diagnostics company operating in the United States and internationally. It develops and commercializes laboratory-developed tests, research-use-only kits, and clinical test kits. Its pipeline includes DetermaCNI, a blood-based monitoring tool for early detection of cancer progression after one treatment cycle, and DetermaIO, a gene expression test that assesses the tumor microenvironment to predict immunotherapy response. The company also offers GraftAssureCore, GraftAssureIQ, and GraftAssureDx for transplant monitoring, and provides biomarker discovery, assay development, and clinical trial support services. It has a collaboration with Bio-Rad Laboratories for transplant products using Bio-Rad's ddPCR instruments and reagents. Formerly OncoCyte Corporation, it changed its name to Insight Molecular Diagnostics Inc. in June 2025, was incorporated in 2009, and is based in Nashville, Tennessee.

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Insight Molecular Diagnostics signals ~$8M quarterly cash burn in H2 2026 while targeting FDA authorization later this year

Insight Molecular Diagnostics updated its expected cash burn to approximately $8 million per quarter for the second half of 2026, up from a prior estimate of roughly $6 million, primarily due to costs tied to completing the regulatory review process, registry activities, and commercial launch preparations for GraftAssureDx. CFO Andrea James noted that the second quarter's $10 million cash burn was the high watermark for the foreseeable future, while the adjusted EBITDA loss narrowed sequentially to $7.8 million. CEO Joshua Riggs said the company continues to target FDA marketing authorization for GraftAssureDx later this year and highlighted that Medicare's expanded reimbursement guidelines, which increase surveillance from 8 to 14 tests in the first three years post kidney transplant, strengthen the economic case for the test. Management also pointed to levers such as registry acceleration and reimbursed Nashville lab testing at $2,753 per result to extend its cash runway.
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iMDx and ASTS Award $100,000 Health Economics Research Grant for Transplant Testing

Insight Molecular Diagnostics and the American Society of Transplant Surgeons have awarded a $100,000 research grant to Kenneth Andreoni of Thomas Jefferson University and Kenneth Chavin of Temple Health to study the health economics of in-house versus send-out donor-derived cell-free DNA testing in kidney transplantation. The grant, funded by iMDx and administered through ASTS, will support econometric research comparing costs, clinical impact, and operational implications of the two testing approaches. The findings are expected to inform commercialization planning for GraftAssureDx, iMDx's kitted in vitro diagnostic currently under FDA review. Dr. Andreoni serves as Surgical Director of Kidney Transplantation at Thomas Jefferson University, while Dr. Chavin holds appointments at Temple Health with combined training in medicine, business, and science. The research aims to provide rigorous data to help transplant programs evaluate laboratory infrastructure and assay selection as interest in in-house testing grows.
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Insight Molecular Diagnostics reports GraftAssure assay data showing statistical superiority in kidney transplant rejection monitoring

Insight Molecular Diagnostics Inc. announced the online publication in the American Journal of Transplantation of new data demonstrating the statistical superiority of its flagship GraftAssure transplant rejection monitoring assay. The study showed that the novel GraftAssure Combination Model score, which integrates relative and absolute DNA fragment measurements, strongly correlates with kidney transplant rejection, confirming its reliability over non-rejection cases. First presented at the World Transplant Congress in 2025, the findings highlight the assay's potential to help physicians distinguish rejection from other causes of organ damage. The data and its implications will be further discussed at the American Transplant Congress in Boston from June 20 to 24, 2026. Meanwhile, BTIG reiterated its Neutral rating on May 15, awaiting FDA approval of GraftAssureDx, the company's test kit designed to expand access to kidney transplant monitoring in a market exceeding two billion dollars.
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