Insight Molecular Diagnostics, Inc. (Nasdaq: IMDX), (“iMDx”), announced two major developments related to its focus in kidney transplant rejection: the launch of a 5,000-patient real-world registry and the enrollment of the first patient in its pivotal GraftAssureDx clinical trial. Together, these initiatives underscore iMDx’s commitment to advancing innovative testing solutions in an estimated $1 billion market for transplant rejection diagnostics.
Novel Registry Program
The newly announced registry is designed to gather data from approximately 5,000 patients across at least 25 centers over three years, supported by iMDx’s central lab and hospital partners. It is expected to generate around 50,000 samples to further validate the company’s proprietary algorithm that combines both percent and total donor-derived cell-free DNA (dd-cfDNA) into a single rejection risk score.
The registry will also evaluate the “Berlin Protocol,” a testing approach tailored to high-risk patients with donor-specific antibodies, aimed at improving monitoring frequency and outcomes. iMDx anticipates that many participating centers may ultimately transition to in-house use of its kitted assay once regulatory clearance is obtained.
“We believe this registry will provide important real-world insights that support both our assay’s clinical utility and its role in transforming transplant care,” said CEO Josh Riggs. “The work also complements our broader commercial strategy and our planned revenue acceleration at the Nashville lab.”
GraftAssureDx Clinical Trial
In parallel, iMDx has begun enrolling patients in its GraftAssureDx clinical trial, with the first participant enrolled on September 2nd. The ClinicalTrials.gov listing now includes 10 leading transplant centers, up from five previously, reflecting strong momentum and clinical interest. The observational study aims to enroll up to 125 patients by year-end, with results supporting an FDA submission targeted for late 2025 and a commercial launch in 2026.
The GraftAssureDx kitted test would mark the third product in the company’s transplant monitoring portfolio, joining GraftAssureCore, its Medicare-reimbursed laboratory-developed test priced at $2,753 per result, and GraftAssureIQ, a research-use-only assay.
“Our clinical team has moved swiftly to initiate this study, and we remain highly focused on bringing GraftAssureDx to FDA review by year-end,” Riggs said. “These milestones highlight the strength of our scientific leadership and the urgency of advancing new solutions for patients.”
Clinical and Financial Tailwinds
iMDx’s innovations follow favorable industry and company-specific developments earlier this year. In January, the company achieved claims expansion for dd-cfDNA testing in CLIA-certified labs, while in May, the Centers for Medicare & Medicaid Services raised reimbursement for GraftAssureCore. Most recently, late-breaking data presented at the World Transplant Congress in August demonstrated that iMDx’s combined algorithm approach improved predictive value for graft rejection, reducing false positives and unnecessary biopsies.
Chief Science Officer Dr. Ekkehard Schuetz emphasized the dual innovation driving iMDx’s approach: “Our algorithm integrating absolute and relative dd-cfDNA levels enhances biopsy yields, while the Berlin Protocol defines a more effective testing cadence for high-risk patients. Together, these advances are reshaping transplant monitoring.”
Outlook
With a strengthened clinical pipeline, expanding hospital participation, and a newly launched registry to capture real-world data, iMDx is advancing a strategy that combines scientific innovation with financial discipline. The company believes these efforts position it to deliver best-in-class solutions for kidney transplant patients and capitalize on a growing market opportunity.
About Insight Molecular Diagnostics Inc.
Insight Molecular Diagnostics Inc., or iMDx, formerly Oncocyte Corp. (OCX), is a pioneering diagnostics technology company whose mission is to democratize access to novel molecular diagnostic testing to improve patient outcomes. iMDx utilizes a novel approach to quantification of donor-derived cell-free DNA, or dd-cfDNA, an established molecular biomarker of transplant rejection.
iMDx™, GraftAssureCore™, GraftAssureIQ™, GraftAssureDx™, and VitaGraft™ are trademarks of Insight Molecular Diagnostics Inc.
Insight Molecular Diagnostics (Nasdaq: IMDX) moved its headquarters from Irvine, Calif., to Nashville, Tenn., in June 2025. The company’s new NASDAQ symbol became effective June 18. Investors may visit https://investors.imdxinc.com/ for more information.
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