INSIGHT MOLECULAR DIAGNOSTICS INC Stock Price, News & Analysis

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.

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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.

iMDx (NASDAQ:IMDX) announced positive results from a head-to-head study comparing its GraftAssureIQ digital PCR-based test kit with NGS-based technology for kidney transplant rejection testing. The study, conducted at University Hospital Heidelberg, evaluated 96 kidney transplant recipients and demonstrated equivalent measurements between the two platforms in detecting donor-derived cell-free DNA (dd-cfDNA).

The company's digital PCR technology showed improved analytical sensitivity in detecting dd-cfDNA in low quantities. This data supports iMDx's preparation for commercial launch following expected regulatory approval in 2026, targeting the estimated $1 billion transplant rejection testing market. Extended study data will be presented at the upcoming European Society of Organ Transplantation Congress in London.

Insight Molecular Diagnostics Inc. (iMDx), formerly Oncocyte Corporation, announced its corporate rebranding and headquarters relocation from Irvine, California to Nashville, Tennessee. The company's stock will trade under the new symbol "IMDX" starting June 18, 2025. The rebranding better reflects the company's expanded focus beyond oncology into transplant medicine, targeting a $1 billion addressable market for transplant rejection testing. The company unveiled a new logo featuring DNA banding patterns and unveiled updated product mapping, unifying its transplant diagnostics under the GraftAssure brand with three distinct products: GraftAssureCore (lab test), GraftAssureIQ (research kit), and GraftAssureDx (in-development IVD kit). iMDx will maintain its CLIA-certified lab in Nashville and research center in Göttingen, Germany, while exhibiting at the ESOT Congress in London to promote its GraftAssureIQ research program.