IMDX

4 - Insight Molecular Diagnostics Inc. (0001642380) (Issuer)

Positive real-world head-to-head data on GraftAssureTM assay to be presented at the 39th European Immunogenetics and Histocompatibility Conference (EFI2026), April 21–24, 2026 in Edinburgh, ScotlandThree posters to be presented at the 63rd European Renal Association (ERA) Congress, June 3–6, 2026 in Glasgow, ScotlandFavorable real-world evidence poster to be presented at the American Transplant Congress (ATC), June 20–24, 2026 in BostonUnaudited first quarter 2026 cash balance of $29.4 million is in line with year-end and Q4 2025 conference call guidanceCompany to host fireside chat and one-on-one meetings with investors at Needham Virtual Healthcare Conference on Wednesday, April 15th NAS

4 - Insight Molecular Diagnostics Inc. (0001642380) (Issuer)

4 - Insight Molecular Diagnostics Inc. (0001642380) (Issuer)

4 - Insight Molecular Diagnostics Inc. (0001642380) (Issuer)

10-K - Insight Molecular Diagnostics Inc. (0001642380) (Filer)

8-K - Insight Molecular Diagnostics Inc. (0001642380) (Filer)

Submitted GraftAssureDx™ for kidney transplant rejection testing for FDA review on Wednesday, March 25Welcomed second favorable head-to-head data set from an independent study at large hospital comparing GraftAssure to a leading centralized transplant rejection testExpect U.K. CE marking via self-certification in Q2 2026Completed $26 million financing in February; funds intended to support expansion into heart transplantation market while also commercializing testing for kidney NASHVILLE, Tenn., March 26, 2026 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., iMDx, (NASDAQ:IMDX), today published the following letter to shareholders in conjunction with its fourth quarter results: Fe

NASHVILLE, Tenn., March 20, 2026 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., (NASDAQ:IMDX), (iMDx), today announced that it will report fourth quarter 2025 financial results after the market closes on Thursday, March 26, 2026. iMDx will host a live Zoom webinar to discuss the company's financial results at 2:00 pm PT / 5:00 pm ET that same day. The live webinar to discuss financial results, followed by Q&A, will be accessible via registration at the following link: iMDx Q4 2025 Earnings Webinar. An archived replay will be available after the call concludes on iMDx's website within the Investors/Events & Presentations section here. Attendance at 25th Annual Needham Virtual He

New data supports GraftAssure commercialization effortsMulti-center study featured 249 biopsy-matched patientsProprietary "Combination Model" score outperformed percentage-only measures of dd-cfDNAReinforces data presented at World Transplant Congress in 2025 NASHVILLE, Tenn., March 13, 2026 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc. (NASDAQ:IMDX) ("iMDx") today highlighted the publication of a new peer-reviewed study demonstrating the potential superiority of the company's flagship GraftAssureTM assay technology. The study, published in Transplant International, and titled "Donor-Derived Cell-Free DNA as a Non-Invasive Readout of Activity Across the Rejection Continu

Three-site reproducibility study completed by Tampa General Hospital, Mayo Clinic, and Baylor Scott & White HealthSufficient clinical samples collected to support statistical analysis and FDA submissionCompany achieved final ISO 13485 certification on Feb. 26, enabling U.K. and E.U. regulatory submissions NASHVILLE, Tenn., March 03, 2026 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc. (NASDAQ:IMDX) ("iMDx") today announced that in February the company completed several major milestones to support the GraftAssureDx™ test kit clinical trial for its planned in vitro diagnostic (IVD) De Novo submission to the U.S. Food and Drug Administration (FDA) and also received its ISO 13485 certi

8-K - Insight Molecular Diagnostics Inc. (0001642380) (Filer)

SCHEDULE 13D/A - Insight Molecular Diagnostics Inc. (0001642380) (Subject)

4 - Insight Molecular Diagnostics Inc. (0001642380) (Issuer)

8-K - Insight Molecular Diagnostics Inc. (0001642380) (Filer)

424B5 - Insight Molecular Diagnostics Inc. (0001642380) (Filer)

8-K - Insight Molecular Diagnostics Inc. (0001642380) (Filer)

NASHVILLE, Tenn., Feb. 11, 2026 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., (NASDAQ:IMDX), ("iMDx" or the "Company"), today announced that it has entered into definitive agreements with certain institutional investors for the purchase and sale of an aggregate of 4,525,976 shares of its common stock, no par value per share (or pre-funded warrants in lieu thereof) at an offering price of $5.75 per share in a registered direct offering. The purchase price per pre-funded warrant is identical to the purchase price per share of common stock, less the exercise price of $0.0001 per share. The offering is expected to close on February 12, 2026, subject to the satisfaction of customary c

American Journal of Transplantation position paper also highlights value of absolute quantification of dd-cfDNA as a diagnostic marker, a key feature of iMDx's flagship GraftAssureTM family of assays NASHVILLE, Tenn., Jan. 13, 2026 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., (NASDAQ:IMDX), (iMDx), today congratulated the STAR working group on its position paper in the American Journal of Transplantation in recognizing the need for decentralized organ health testing in the global transplant community. Specifically, the publication states, "High-quality, standardized decentralized dd-cfDNA testing is the essential prerequisite for conducting real-world evidence-generating multi

NASHVILLE, Tenn., Jan. 07, 2026 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., or iMDx, (NASDAQ:IMDX), today announced members of its management team will participate in the following investor conferences this winter, which will include hosting meetings around the annual J.P. Morgan Healthcare Conference. LifeSci Advisors 15th Annual Corporate Access Event Date: Monday, January 12thLocation: The Beacon Grand, San Francisco, Calif.Format: One-on-one meetings with management Additional "JPM Week" Investor MeetingsDate: Monday, January 12th through Wednesday, January 14thLocation: San Francisco, Calif.Format: One-on-one meetings with management BTIG 13th Annual Snowbird MedTech, D

Dr. Nick Ioannou brings decades of academia, industry, and clinical experience in organ transplant, nephrology, cardiology, genetics, and oncology NASHVILLE, Tenn., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., (NASDAQ:IMDX), or iMDx, today announced that it has appointed Dr. Nick Ioannou, M.D., MHA, to the position of Vice President, Medical Affairs. Dr. Ioannou is a physician-scientist with more than three decades of highly relevant experience spanning clinical practice, diagnostics, regulatory affairs, medical education, and medical affairs. His background includes over fifteen years of field-based collaboration with key opinion leaders across multiple therapeu

GraftAssure™ technology adoption further broadens with 20 global transplant centers engaged by year-end 2025, including first Canadian siteGraftAssureDx™ FDA IVD approval application 95% complete at year-end; expect full submission in coming weeksAccelerating planned UK CE mark and EU IVDR submission to first half 2026, following successful TÜV SÜD ISO 13485 stage 1 & 2 audit completions in Q4 2025Strong engagement from clinical community on GraftAssureCore™ kidney registry with 17 U.S. transplant centers now planning to send samples in 2026Management to be in San Francisco for meetings during "JPM Week," January 12 to 15, 2026 NASHVILLE, Tenn., Jan. 05, 2026 (GLOBE NEWSWIRE) -- Insight M

4/A - Insight Molecular Diagnostics Inc. (0001642380) (Issuer)

10-Q - Insight Molecular Diagnostics Inc. (0001642380) (Filer)

8-K - Insight Molecular Diagnostics Inc. (0001642380) (Filer)