Insight Molecular Diagnostics Enrolls Patients In Its Clinical Trial To Assess GraftAssureDx

• iMDx's ClinicalTrials.gov listing now names 10 leading transplant centers, up from 5 previously
• GraftAssureDx remains on track for FDA submission by end of 2025, commercial launch in 2026

NASHVILLE, Tenn., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics, or iMDx, (NASDAQ:IMDX), today announced that it is actively enrolling patients in its clinical trial to assess GraftAssureDx and that last week, it enrolled the first patient. In addition, the official clinical trial listing now names 10 leading transplant centers, up from five previously.

The ongoing clinical trial is an important step toward obtaining regulatory authorization to deliver an organ transplant rejection monitoring test kit to the estimated $1 billion addressable market for kitted transplant rejection testing.

The goal of this observational study is to determine that the GraftAssureDx kitted test can assess rejection in kidney transplant recipients. The company anticipates enrolling up to 125 patients and completing the trial by year-end.