INSIGHT MOLECULAR DIAGNOSTICS INC Stock Price, News & Analysis

Insight Molecular Diagnostics (Nasdaq: IMDX) reported an American Journal of Transplantation case study where its GraftAssure dd-cfDNA assay monitored a 33-year-old kidney transplant patient treated with CD19 CAR-T therapy.

GraftAssure testing reportedly confirmed absence of rejection while conventional immunosuppression was stopped, with stable graft function and oncologic remission sustained through about 23 months, suggesting a possible "immune reset." The company notes GraftAssureCore is reimbursed by CMS, GraftAssureIQ became available for RUO in summer 2024, and GraftAssureDx is in development with planned FDA submission in 2025; the firm cites a $1 billion addressable market for kitted transplant testing.

Insight Molecular Diagnostics (NASDAQ:IMDX) announced its participation in two major industry conferences to showcase its GraftAssure™ transplant rejection testing technology. The company will host a symposium at the IATDMCT annual meeting in Singapore (September 21-24) and present at the ASHI annual meeting in Orlando (October 6-10).

IMDX will discuss its GraftAssureIQ™ research-use-only test kit and the development of GraftAssureDx™, its clinical kitted test. Both tests measure donor-derived cell-free DNA (dd-cfDNA) for transplant rejection detection. The company plans to submit GraftAssureDx for FDA review by year-end and estimates an addressable market of $1 billion for kitted transplant rejection testing.

Insight Molecular Diagnostics (NASDAQ:IMDX) announced a strategic initiative to launch a novel registry database for its kidney transplant rejection assay. The registry will enroll 5,000 patients across 25+ centers over three years, collecting approximately 50,000 samples. The program will evaluate the company's unique "combined score" algorithm and the "Berlin protocol" for accelerated testing in high-risk patients.

The announcement follows several key milestones in 2025, including claims expansion for dd-cfDNA testing, increased CMS reimbursement to $2,753 for GraftAssureCore, and positive clinical data presented at the World Transplant Congress. The company is targeting an estimated $1 billion addressable market for transplant rejection testing with its GraftAssure™ product line.

Insight Molecular Diagnostics (NASDAQ:IMDX) has initiated patient enrollment in its clinical trial for GraftAssureDx, a kidney transplant rejection monitoring test kit. The company has successfully enrolled its first patient on September 2nd, 2025, and expanded its trial sites from 5 to 10 leading transplant centers.

The observational study aims to enroll up to 125 patients and targets completion by year-end 2025, with FDA submission planned for the same period. GraftAssureDx will be the third product in the GraftAssure family, targeting an estimated $1 billion addressable market. The company currently offers GraftAssureCore (with Medicare reimbursement of $2,753 per result) and GraftAssureIQ (for research use only).

iMDx (NASDAQ:IMDX) announced its participation in two upcoming investor conferences in New York City. The company will present at the H.C. Wainwright 27th Annual Global Investment Conference on September 8-9, 2025, featuring a company presentation on September 8 at 5:00 pm ET, along with one-on-one meetings.

Additionally, iMDx will participate in the Lake Street Capital Markets 9th Annual Best Ideas Growth Conference on September 11, 2025, which will consist of one-on-one meetings with investors at the Yale Club of New York City.

Insight Molecular Diagnostics (NASDAQ:IMDX) reported Q2 2025 results and progress toward launching GraftAssureDx, their FDA-submission-pending transplant monitoring assay. The company generated $518,000 in Q2 revenue primarily from laboratory services and initial GraftAssureIQ research kit sales.

Key developments include: productive FDA meetings for GraftAssureDx submission planned for end-2025, partnership with leading transplant hospitals including Mayo Clinic and Cleveland Clinic for clinical trials, and increased Medicare reimbursement to $2,753 per test. The company aims to capture share in the $1 billion transplant rejection testing market through their regulated kitted assay strategy.

IMDX's enhanced second-generation GraftAssureIQ kits began shipping in June, and new clinical data demonstrated improved rejection prediction capabilities through their proprietary combined scoring system.

Insight Molecular Diagnostics (Nasdaq: IMDX) has scheduled its second quarter 2025 financial results release for August 11, 2025, after market close. The company will host a live Zoom webinar at 2:00 PM PT / 5:00 PM ET on the same day to discuss the results, followed by a Q&A session.

Additionally, CEO Josh Riggs and CFO Andrea James will participate in the 10th Annual Needham Virtual MedTech & Diagnostics Conference on August 12, 2025, where they will be available for one-on-one meetings with investors.

Insight Molecular Diagnostics (NASDAQ:IMDX) announced groundbreaking late-breaking data at the World Transplant Congress regarding their novel approach to kidney transplant rejection testing. The study, analyzing 403 samples across five clinical cohorts, demonstrated that combining relative and absolute measurements of donor-derived cell-free DNA (dd-cfDNA) achieved a remarkable 79% positive predictive value for graft rejection, significantly higher than the 48% industry average.

The company's GraftAssure™ technology demonstrated an impressive 93% negative predictive value and uniquely distinguished all types of rejection from non-rejection pathologies. This breakthrough could potentially transform dd-cfDNA testing paradigms and expand clinical applications in the estimated $1 billion transplant rejection testing market.

iMDx (Nasdaq: IMDX) has announced a virtual Key Opinion Leader (KOL) event scheduled for August 15, 2025, at 4:00 PM ET. The event will feature Dr. Anthony Langone, Associate Professor at Vanderbilt University and national principal investigator for iMDx's kidney transplant monitoring trial.

The presentation will focus on the company's GraftAssure™ testing platform, which uses digital PCR technology for donor-derived cell-free DNA (dd-cfDNA) transplant monitoring. Management will discuss their strategy for in-house testing capabilities and the development of a diagnostic test kit for clinical use. A Q&A session will follow the presentations, with advance questions accepted via email.