Insight Molecular Diagnostics (NASDAQ: IMDX) hosted a virtual Key Opinion Leader (KOL) event on August 15, 2025, showcasing the promise of its in-house donor-derived cell-free DNA (dd-cfDNA) assay, GraftAssureDx, for kidney transplant monitoring. The event featured Dr. Anthony Langone, Associate Professor of Medicine at Vanderbilt University Medical Center, alongside IMDX’s executive team.
A Market Ripe for Disruption
Today, dd-cfDNA testing is a standard-of-care biomarker for detecting early signs of transplant rejection, but the market is dominated by two central labs that control nearly 90% of U.S. volume. These tests require shipping samples to outside laboratories, creating logistical burdens and turnaround times of five to seven days. IMDX believes GraftAssureDx, which is designed to deliver same-day results within hospital labs, has the potential to upend this model by putting testing directly into the hands of transplant centers and nephrology practices. Dr. Langone stated, “I am excited by the technology and the turnaround because I think it is going to be a game changer.”
Clinical Validation Underway
IMDX has begun enrolling patients in its GraftAssureDx FDA validation trial. The study aims to demonstrate non-inferiority compared to biopsies and currently marketed dd-cfDNA assays, with enrollment expected to reach 125–150 patients across leading U.S. and European transplant centers. Five of the top ten U.S. programs, including Vanderbilt, Cleveland Clinic, Mayo Clinic Florida, Tampa General, and Intermountain, are participating.
Success would establish GraftAssureDx as a clinically validated, FDA-cleared alternative that could shorten time-to-diagnosis, reduce the need for invasive biopsies, and improve patient outcomes.
KOL Perspective: Faster, More Practical, and Potentially More Informative
Dr. Langone described cfDNA testing as an essential tool for monitoring transplant health, noting he already uses it in most cases instead of biopsy. However, he emphasized that current next-generation sequencing (NGS) tests face limitations, including shipping delays that can invalidate samples. By offering near-real-time results and enabling hospitals to keep testing in-house, he expects GraftAssureDx to become a compelling solution for transplant programs.
He also highlighted the assay’s design advantages, including the ability to measure both absolute and relative cfDNA concentrations, which could improve positive predictive value and reduce false positives, reducing the need for unnecessary biopsies. Langone noted that slope analysis from serial testing could allow earlier detection of rejection, even before thresholds are crossed. Importantly, he expressed confidence that he could shift all cfDNA testing at Vanderbilt to GraftAssureDx once it receives FDA clearance.
Commercial Strategy and Market Opportunity
IMDX estimates a $1 billion addressable market for GraftAssureDx based on 150,000 annual organ transplants and over 1.5 million transplant patients globally. Patients are typically tested two to three times annually, with Langone suggesting quarterly testing could become standard practice. At scale, IMDX projects high gross margins, with each transplant center capable of generating approximately $1 million per year in recurring revenue.
The company is executing a “land and expand” strategy through its partnership with Bio-Rad Laboratories, initially launching GraftAssureIQ (the research-use-only version) to familiarize clinicians with the workflow. Fourteen centers are already running GraftAssure in some capacity, whether to perform research or support the clinical trial, and management has said that it expects 20 centers to be onboarded by the end of 2025.
Analyst Takeaway
Needham & Company reiterated its Buy rating and $4.25 price target following the event, citing GraftAssureDx’s disruptive potential and the strong endorsement from a leading transplant KOL. Analysts highlighted the assay’s faster turnaround time, higher potential predictive accuracy, and appeal for hospitals seeking to bring testing in-house as major conversion drivers.
Looking Ahead
IMDX anticipates completing its pivotal trial by December 2025, with a potential FDA-cleared launch of GraftAssureDx as early as the second half of 2026. The company also plans to expand the assay into additional transplant indications, including heart, lung, and liver, as well as therapeutic response monitoring and recurrence detection.
“This is just the beginning. We’re not stopping at kidney,” iMDx CEO Josh Riggs said on the company’s August 11 quarterly earnings call. “We plan to immediately expand into additional solid organ transplant indications, building a multi-indication portfolio that we believe can unlock substantial clinical and commercial value. We see heart transplant as the most logical next indication.”
With strong clinical support, a differentiated product design, and a large untapped market, IMDX’s KOL event underscored growing momentum toward making GraftAssureDx a next-generation standard of care in transplant monitoring.
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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