Insight Molecular Diagnostics (iMDx) has achieved a significant milestone in its transplant diagnostics program by enrolling the first patient in its GraftAssureDx clinical trial on September 2nd. The observational study aims to validate the company's kitted transplant rejection monitoring test for kidney transplant recipients, representing a crucial step toward regulatory authorization in the estimated $1 billion addressable market for kitted transplant rejection testing.
The clinical trial has expanded to include 10 leading transplant centers, up from five previously listed on ClinicalTrials.gov. According to the official listing (NCT07060716), participating institutions include Mayo Clinic in Florida, Tampa General Hospital, Cleveland Clinic, Vanderbilt University, and Intermountain Health, among others. The company anticipates enrolling up to 125 patients and completing the trial by year-end.
"We are proud of our momentum at the start of this study as well as the top-tier roster of sites participating," said iMDx CEO Josh Riggs. "I would also like to congratulate iMDx Chief Science Officer Prof. Dr. Ekkehard Schuetz and our clinical team for their diligence and timeliness in initiating this study."
GraftAssure Product Portfolio Development
GraftAssureDx represents the third iteration in iMDx's GraftAssure family of transplant monitoring assays. The company currently offers GraftAssureCore, a laboratory-developed test that has achieved Medicare reimbursement of $2,753 per result, and GraftAssureIQ, a research-use-only kitted assay available for research purposes.
The company's transplant testing technology quantifies donor-derived cell-free DNA (dd-cfDNA), a molecular biomarker that has been established as a trusted indicator of transplant rejection. iMDx scientists in Germany and the U.S. have played a critical role over the past decade in developing the science behind dd-cfDNA as a biomarker.
Regulatory Timeline and Market Strategy
iMDx maintains its timeline for FDA submission by the end of 2025, with commercial launch anticipated in 2026. The company completed a productive meeting with the FDA on July 30, representing its third overall meeting with the agency regarding GraftAssureDx and second pre-submission meeting.
"We continue to be encouraged by our productive dialogue with the FDA and our review team's sincere guidance and engagement," the company stated in its Q2 2025 shareholder letter.
The regulatory pathway is supported by recent Medicare reimbursement improvements. On May 19th, Medicare boosted reimbursement for GraftAssureCore to $2,753 per result, establishing a benchmark that can be used for future kitted test reimbursement pathways.
Clinical Evidence and Differentiation
Recent clinical data presentations have strengthened the scientific foundation for iMDx's approach. At the World Transplant Congress in San Francisco in August, the company presented late-breaking data showing that iMDx offers the first digital PCR assay to combine relative and absolute measurements of dd-cfDNA into a single combined score, resulting in significantly improved positive predictive values.
The proprietary combined score potentially broadens clinical utility for dd-cfDNA by generating fewer false positives than without such combination, further reducing unnecessary invasive biopsies for patients. The company expects to further evaluate this combined score in its ongoing FDA study.
Head-to-head data presented at European conferences in June favorably compared iMDx's digital PCR-based test kits with NGS kits. This data was presented at the European Renal Association conference in Vienna and the European Society for Organ Transplantation Congress in London.
Commercial Preparation and Market Access
The company's "Land and Expand" strategy is gaining traction through its GraftAssureIQ research-use-only kit program. In Q2 2025, iMDx received its first purchase order for GraftAssureIQ kits from a major hospital in Switzerland, representing a key proof point for the RUO pilot program.
The company began shipping optimized second-generation assays in early June, incorporating ease-of-use improvements based on feedback from pilot site customers. These pilot sites represent some of the most scientifically advanced labs in the world and are expected to be among initial clinical kit customers.
MolDx established clarity on surveillance testing in a draft local coverage determination published on July 17, setting a baseline of four monitoring tests in the first year of a transplant and two tests per year thereafter. This provides clarity for hospital customers seeking to bring testing in-house.
Financial Performance and Future Outlook
iMDx reported Q2 2025 revenues of $518,000, derived primarily from laboratory services performed at its Nashville clinical laboratory and nominally from first GraftAssureIQ kit sales. The company achieved a 67.6% gross margin, up from 62% in Q1 2025, driven by operational efficiencies in its Nashville lab.
Looking beyond kidney transplant monitoring, iMDx sees at least six potential areas for clinical and regulatory expansion of dd-cfDNA kitted assays from 2026 to 2028. These include monitoring therapeutic response to immunosuppressive drugs, recurrence monitoring for kidney transplant rejection, urine-based indications, and expansions into heart, lung, and liver transplant rejection testing.
The company maintains $26.0 million in cash, cash equivalents, and restricted cash as of the end of Q2 2025, providing runway to support its regulatory and commercial objectives through the anticipated FDA submission and beyond.
