Insight Molecular Achieves Milestones for GraftAssureDx Trial

Insight Molecular Diagnostics announced that in February the company completed several major milestones to support the GraftAssureDx test kit clinical trial for its planned in vitro diagnostic, IVD, De Novo submission to the U.S. Food and Drug Administration, FDA, and also received its ISO 13485 certification. Beginning in 2026, iMDx seeks to deliver the industry-leading molecular diagnostic test kit for clinical use that expands and improves access to organ health testing for kidney transplant patients. The company expects that enabling localized testing will deliver new value in the roughly $2 billion-plus addressable market for regulated transplant rejection testing. "Our clinical trial sites have now collected the needed number of samples to finalize the clinical trial part for our FDA submission, based on the projected 25% to 30% organ rejection rate, and those results are being gathered at the sites," said iMDx Chief Science Officer Dr. Ekkehard Schuetz. "This combined with the reproducibility study conclusion represents two major milestones, and we are thrilled about the collaboration with our clinical partners to help us achieve our goal of finalizing our de-novo submission."