iMDx Prepares for U.S. Commercial Launch of GraftAssureDx as Clinical Trial Nears Completion
NASHVILLE, Tenn., Jan. 05, 2026 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc. (Nasdaq: IMDX), also known as iMDx, has provided significant updates on its GraftAssureDx™ test kit's clinical trial and regulatory submissions, including its anticipated commercial launch in the United States. With a majority of the work complete for the FDA submission, the company aims to finalize the process and expand its presence in the transplant diagnostics market.
Key Developments in GraftAssureDx™ Submission
As year-end 2025 approaches, iMDx reports that approximately 95% of its FDA submission tasks are complete. These include:
- Product design and development for the GraftAssureDx kit
- Technical transfer to manufacturing
- Production under a regulated quality management system
CEO Josh Riggs expressed enthusiasm for 2026, emphasizing, “We are driving toward making 2026 the year that transplant centers will regain control of their patient samples.” Riggs highlights the partnership with Bio-Rad as pivotal in meeting both domestic and global post-transplant management demands.
Strategic Regulatory Plans for Global Expansion
In addition to the FDA submission, iMDx is accelerating plans for its first half 2026 UK CE mark and EU IVDR submission. These efforts follow the successful completion of TÜV SÜD ISO 13485 stage 1 and 2 audits in Q4 2025.
Dr. Ekkehard Schuetz, Chief Science Officer at iMDx, stated, “The GraftAssure assays run at pilot sites are performing exceptionally well, giving us high confidence in the clinical data being generated for the FDA.”
Expanding Clinical Engagement and Market Adoption
Since November 2025, iMDx has shown substantial progress in engaging with the clinical community. The company's GraftAssureCore™ kidney registry now includes participation from 17 U.S. transplant centers planning to submit samples in 2026. iMDx’s efforts have resulted in a total of 20 global transplant centers engaged in utilizing GraftAssure™ technology, including its first center in Canada.
The GraftAssure Lowering Allograft rejeCTIon by Combination (GALACTIC) registry aims to establish the clinical utility of the company’s digital PCR tests, which leverage donor-derived cell-free DNA (dd-cfDNA)—a critical biomarker for transplant rejection.
iMDx’s Product Portfolio and Future Directions
iMDx is positioned to revolutionize transplant diagnostics with its GraftAssure™ product line:
- GraftAssureCore: A laboratory-developed test (LDT) currently reimbursed by CMS.
- GraftAssureIQ: A research-use-only (RUO) kit for non-clinical applications.
- GraftAssureDx: An in vitro diagnostic (IVD) kit in development for clinical decision-making.
The company anticipates expanding access to organ health testing for kidney transplant patients, tapping into a market valued at over $1 billion for kitted transplant rejection testing.
About Insight Molecular Diagnostics, Inc.
Insight Molecular Diagnostics is dedicated to democratizing access to innovative molecular diagnostic testing to enhance patient outcomes. For more information, investors can visit https://investors.imdxinc.com/.