iMDx prepares for U.S. commercial launch of GraftAssureDx

Insight Molecular Diagnostics (IMDX) provided a year-end business update regarding its commercial progress, its GraftAssureDx test kit clinical trial and planned in vitro diagnostic de novo submission to the United States Food & Drug Administration, as well as its plans for additional regulatory submissions and registry study progress in 2026. “We are very excited about 2026 and being on the cusp of our FDA submission. As we put GraftAssureDx software through its final paces in late November and early December, which involved rigorous quality control testing, we found minor issues that needed to be addressed. We are moving quickly to complete the trial and submit our data package,” iMDx CEO Josh Riggs said. “We are driving toward making 2026 the year that transplant centers will regain control of their patient samples. With our partner Bio-Rad at our side, we’re confident that we’ll be able to meet domestic and global demand for in-house post-transplant management.” The company estimates that about 95% of the work for its FDA submission is complete, including GraftAssureDx kitted product design, development, technical transfer to manufacturing, and production, all under a regulated quality management system. In parallel to managing its FDA timeline, iMDx is also making rapid progress outside of the U.S., positioning the company well for continued growth beyond 2026. The company expects an accelerated submission for European regulatory authorization now in the first half of 2026 after having completed a successful audit from the certification body, TUV SUD. Such regulatory compliance supports market access in Europe.