The emerging diagnostics technology company Insight Molecular Diagnostics Inc. (Nasdaq: IMDX), announced its second quarter 2025 results, highlighting continued progress toward the anticipated launch of its GraftAssureDx kitted transplant monitoring assay and reiterating plans to submit the product for FDA review by the end of the year. The company believes the test has the potential to address a $1 billion total addressable transplant rejection testing market.
In a letter to shareholders, management emphasized the significance of developing a regulated kitted assay, a molecular diagnostic designed for distribution in a boxed kit, enabling localized hospital lab testing. “We are closer than we have ever been to delivering a regulated kitted transplant monitoring assay to the market – and we are pleased to report a series of recent and timely accomplishments that we believe amount to material progress,” the letter stated.
The company explained that obtaining FDA and EU-equivalent authorization would allow hospitals to run the test in-house, speeding up results and potentially democratizing access to transplant monitoring. The goal, management noted, is to create “a rapidly growing, high-margin, recurring revenue business model” while bringing care closer to patients and improving hospital sustainability.
Clinical and Regulatory Progress
Since its May shareholder update, iMDx has advanced on multiple fronts. On July 30, the company held its third meeting with the FDA regarding GraftAssureDx and its second formal pre-submission meeting. The ongoing clinical trial has attracted leading transplant centers including Mayo Clinic in Florida, Tampa General Hospital, Cleveland Clinic, Vanderbilt University, and Intermountain Health. Dr. Anthony J. Langone of Vanderbilt University Medical Center serves as the national principal investigator.
Medicare has boosted reimbursement for the Lab Developed Test version of the company’s assay, GraftAssureCore, to $2,753 per result, establishing a benchmark for future kitted test reimbursement. New data presented at major transplant conferences compared iMDx’s digital PCR-based technology favorably against next-generation sequencing (NGS) kits, and late-breaking findings at the World Transplant Congress demonstrated a proprietary combined score that significantly improved positive predictive values for kidney graft rejection.
Commercial Developments
The company booked its first revenue from GraftAssureIQ research-use-only kits in the quarter, with initial sales to a Swiss hospital. Second-generation kits with workflow improvements began shipping in June to pilot sites. The “Land and Expand” strategy aims to transition research customers into clinical kit users once regulatory clearance is obtained.
Oncology Pipeline and Corporate Changes
Beyond transplant testing, iMDx reported momentum in its oncology pipeline, including a non-binding development letter of intent with a major instrument maker for its DetermaIO immuno-oncology assay. The company also secured a U.S. patent covering a method for detecting colorectal cancer via circulating nucleic acid biomarkers.
In June, the company rebranded from Oncocyte to Insight Molecular Diagnostics and relocated its headquarters to Nashville, Tenn., home to its accredited lab. CEO Josh Riggs stated, “While molecular diagnostic testing has advanced significantly in recent years, many times access remains limited — constrained by geography, cost, and the need for centralized labs. Our mission is to democratize access to molecular diagnostic testing to improve patient outcomes. We aim to lead in molecular diagnostics by doing what sets technology companies apart: developing proprietary algorithms that drive scalable value.”
Financial Results
For Q2 2025, iMDx reported revenue of $518,000, up from $104,000 in the same period last year, primarily from laboratory services. Gross profit was $350,000, representing a 67.6% margin, an improvement from 62% in Q1. The company posted a net loss of $9.7 million, or ($0.30) per share, and a non-GAAP loss from operations of $5.98 million.
Cash, cash equivalents, and restricted cash totaled $26.0 million at quarter-end, bolstered by $28.7 million in net proceeds from earlier financings. Operating cash outflow was $6.3 million, with management noting that second- and third-quarter spending was expected to be slightly above the $6 million quarterly average due to FDA program investments.
iMDx Outlook
iMDx reiterated its goal of submitting GraftAssureDx to the FDA by year-end, with potential market launch in mid-2026 pending authorization. The company also sees opportunities for expanding its dd-cfDNA testing platform into heart, lung, and liver transplant rejection, as well as additional monitoring applications.
Management concluded, “We look forward to continuing to update you on our scientific and commercial progress.”
About Insight Molecular Diagnostics, Inc.
Insight Molecular Diagnostics is a pioneering diagnostics technology company whose mission is to democratize access to novel molecular diagnostic testing to improve patient outcomes. Investors may visit https://investors.Insight Molecular Diagnostics.com/ for more information.
GraftAssureCore™, GraftAssureIQ™, GraftAssureDx™, VitaGraft™, GraftAssure™, DetermaIO™, and DetermaCNI™ are trademarks of Insight Molecular Diagnostics Inc.
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