IMDX News & Events

The company said, "We are pleased to share that GraftAssureDx has become, to our knowledge, the first ever kitted dd-cfDNA assay to be submitted to the FDA for regulatory review. Our FDA submission this week represents the culmination of 12 years of clinical development and three years of highly focused technical product development. We see many positive signals that the transplant community is ready for GraftAssureDx."

Reports Q4 revenue $1.14M vs. $1.49M last year. The company said, "In 2026, we expect to continue to be thoughtful about capital allocation, hiring, and expense growth. We expect to average cash burn of about $7.5 million per quarter in 2026 - with outgoing cash flow above $8 million per quarter in the first half, and dropping down to historical cash burn levels of $6 million per quarter in the back half."

Insight Molecular Diagnostics highlighted the publication of a new peer-reviewed study demonstrating the potential superiority of the company's GraftAssure assay technology. The study, published in Transplant International, and titled "Donor-Derived Cell-Free DNA as a Non-Invasive Readout of Activity Across the Rejection Continuum," was conducted by investigators from Heidelberg University Hospital and Charite - Universitatsmedizin Berlin and included iMDx scientist authors. This new study, combined with data presented at World Transplant Congress in 2025, point to growing clinical differentiation and marketability of the GraftAssure technology and support iMDx's strategic vision. Beginning in 2026, iMDx seeks to deliver the molecular diagnostic test kit for clinical use that expands and improves access to organ health testing for kidney transplant patients.

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."