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

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

On track to submit GraftAssureDx™ for FDA review by year-endOn track for commitment to have 20 transplant centers globally engaged with GraftAssure technology by end of 2025GraftAssure assay's head-to-head data continue to be favorablePreparing to rapidly expand beyond kidney into heart transplant testing NASHVILLE, Tenn., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., or iMDx, (NASDAQ:IMDX), today published the following letter to shareholders in conjunction with its third quarter results:  Fellow shareholders, There is a palpable level of excitement and activation energy coursing through our company as we prepare to submit our application for approval of our fir

NASHVILLE, Tenn., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., (NASDAQ:IMDX), (iMDx), today announced that it will report third quarter 2025 financial results after the market closes on Monday, November 10, 2025. 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 Q3 2025 Earnings Webinar. An archived replay will be available after the call concludes on iMDX's investor relations website at  https://investors.imdxinc.com/. Stephens NASH25 ConferenceSeparately, on Novembe

Steven Tahmooressi to lead global marketing efforts for GraftAssure family of assays and future productsBrings 25 years of experience driving new product adoption across geographies in transplantation, oncology and immunology NASHVILLE, Tenn., Oct. 13, 2025 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., (NASDAQ:IMDX), (iMDx), today announced that it has welcomed Steven Tahmooressi to its executive leadership team as the company prepares to launch its first clinical kitted assay in 2026. As Vice President of Marketing, Mr. Tahmooressi will be responsible for leading transplant and oncology assay marketing, bringing more than 25 years of healthcare industry experience, including

American Journal of Transplantation study positions GraftAssure as potentially essential in managing immunosuppression treatment in kidney transplant patients with certain cancersGraftAssure used to help avoid overtreatment and preserve patient's immune systemAs transplant care evolves to include novel therapies, the need for ongoing molecular diagnostic monitoring should continue to grow NASHVILLE, Tenn., Oct. 06, 2025 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., (NASDAQ:IMDX), (iMDx), today announced results from a study conducted by iMDx researchers and partners published in the American Journal of Transplantation, that demonstrated the value of its GraftAssure assay for lon

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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

On track to submit GraftAssureDx™ for FDA review by year-endOn track for commitment to have 20 transplant centers globally engaged with GraftAssure technology by end of 2025GraftAssure assay's head-to-head data continue to be favorablePreparing to rapidly expand beyond kidney into heart transplant testing NASHVILLE, Tenn., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., or iMDx, (NASDAQ:IMDX), today published the following letter to shareholders in conjunction with its third quarter results:  Fellow shareholders, There is a palpable level of excitement and activation energy coursing through our company as we prepare to submit our application for approval of our fir

NASHVILLE, Tenn., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., (NASDAQ:IMDX), (iMDx), today announced that it will report third quarter 2025 financial results after the market closes on Monday, November 10, 2025. 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 Q3 2025 Earnings Webinar. An archived replay will be available after the call concludes on iMDX's investor relations website at  https://investors.imdxinc.com/. Stephens NASH25 ConferenceSeparately, on Novembe

NASHVILLE, Tenn., Aug. 04, 2025 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics, or iMDx, (NASDAQ:IMDX), today announced that it will report second quarter 2025 financial results after the market closes on Monday, August 11, 2025. 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 Q2 2025 Earnings Webinar. An archived replay will be available after the call concludes on iMDX's investor relations website at https://investors.imdxinc.com/. 10th Annual Needham Virtual MedTech & Diagnostics 1x1

iMDx first dd-PCR assay to combine relative and absolute measurements of dd-cfDNA into single combined scoreData show significantly improved positive predictive value (PPV) for graft rejection, which potentially broadens clinical utility for dd-cfDNA with fewer false positives, further reducing unnecessary invasive biopsies for patientsiMDx expects to evaluate combined score in ongoing FDA study (NCT07060716)iMDx will be exhibiting at Booth #324 at the World Transplant CongressNational Principal Investigator and Key Opinion Leader call Friday, August 15th at 4 p.m. ET to discuss GraftAssureTM - branded family of assays NASHVILLE, Tenn., July 30, 2025 (GLOBE NEWSWIRE) -- Insight Molecular

Study indicates iMDx flagship technology's equivalence with commercially available dd-cfDNA test kitsHead-to-head comparison of iMDx's digital PCR-based test kits with NGS kits shows consistent results in 96 transplant patientsData was presented at the European Renal Association (ERA) 2025Extended data to be presented at the European Society of Organ Transplantation (ESOT) Congress in London, June 29 – July 2Upcoming National Principal Investigator and Key Opinion Leader call planned NASHVILLE, Tenn., June 23, 2025 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics, or iMDx, (NASDAQ:IMDX), today announced positive results from a study evaluating its flagship test kit technology in a head-t