Insight Molecular Diagnostics Inc., (NASDAQ: IMDX) shares enjoyed strong gains at first Monday, on providing a year-end business update regarding its commercial progress, its GraftAssureDx™ test kit clinical trial and planned in vitro diagnostic (IVD) de novo submission to the United States Food & Drug Administration (FDA), as well as its plans for additional regulatory submissions and registry study progress in 2026.
To quote CEO Josh Riggs, “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.
“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.”
iMDx’s flagship transplant testing technology quantifies a molecular biomarker known as donor-derived cell-free DNA (dd-cfDNA). The company’s scientists in Germany and the U.S. have played a critical role over the past decade in developing the science that helped establish dd-cfDNA as a trusted biomarker of transplant rejection. iMDx is commercializing this technology using a market-disruptive business strategy.
IMDX opened Monday up 22 cents, or 3.1%, to $7.38.
