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

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

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

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

DEFA14A - Insight Molecular Diagnostics Inc. (0001642380) (Filer)

DEF 14A - Insight Molecular Diagnostics Inc. (0001642380) (Filer)

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

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

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

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

Industry-wide coverage policy expands reimbursement framework for donor-derived cell-free DNA testingSupports iMDx's commercial strategy in transplant monitoringFinal policy establishes recurring testing baseline opportunity, providing reimbursement clarity on surveillance testing for hospitals, physicians, and laboratoriesFinal policy cites iMDx-affiliated research, affirming iMDx’s scientific leadership in the industry NASHVILLE, Tenn., July 16, 2026 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., (NASDAQ:IMDX), (iMDx), today highlighted a favorable new Medicare policy supporting expanded coverage for donor-derived cell-free DNA (dd-cfDNA) testing in transplant care. The co

Key member of management ranks at top 2% of researchers in the field of laboratory diagnostics and top 2.5% of all researchers worldwide, based on H-index of 58Recent studies advanced science of molecular diagnostic testing for transplanted organ rejection, published in Clinical Chemistry, Transplant International, American Journal of Transplantation and Nephrology Dialysis Transplantation, among others NASHVILLE, Tenn., June 29, 2026 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., (NASDAQ:IMDX), (iMDx), today announced that its Chief Science Officer, Prof. Dr. Ekkehard Schuetz. M.D., Ph.D., has published his 200th scientific article. Dr. Schuetz and Dr. Julia Beck are credited a

-Grant Supports Health Economic Research Comparing In-House versus Send-Out dd-cfDNA Testing in Kidney Transplantation- NASHVILLE, Tenn., June 22, 2026 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., (NASDAQ:IMDX), (iMDx), and the American Society of Transplant Surgeons (ASTS) today announced the selection of Kenneth Andreoni, MD, Surgical Director of Kidney Transplantation at Thomas Jefferson University, and Kenneth Chavin, MD, MBA, PhD, FACS, of Temple Health, as the recipients of the ASTS-iMDx Research Grant for Understanding the Health Economics of In-House versus Send-Out of donor-derived cell-free DNA (dd-cfDNA) testing. The pursuit of this research is timely as the transpla

Peer-reviewed journal Clinical Chemistry published the first head-to-head study comparing GraftAssure™ to industry-leading competitorGraftAssure's industry-leading reference change value (time-point to time-point change) supports transplanted organ health screening and rejection recurrence monitoring NASHVILLE, Tenn., June 16, 2026 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., (NASDAQ:IMDX) ("iMDx") today announced the online publication of a favorable article in Clinical Chemistry, the premier, peer-reviewed scientific publication of the Association for Diagnostics & Laboratory Medicine. The article highlights the concordant performance between iMDx's digital-PCR-based flagship

American Journal of Transplantation publishes public pre-proof showing novel CM-score superior to either fractional or absolute measurement of dd-cfDNA aloneGraftAssure™ assay doubles reliability of positive results in screening cohortIn for-cause testing of kidney transplant patients, the positive predictive value using the CM-Score increased to greater than 80% NASHVILLE, Tenn., June 11, 2026 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., (NASDAQ:IMDX), (iMDx), today announced an online published article in the American Journal of Transplantation asserting statistical superiority of the company's flagship GraftAssure transplant rejection monitoring assay. IMDx's newly develope

Multiple events and presentations will highlight potential benefits of in-house transplanted-organ-rejection testing, and of GraftAssure technology specificallyMajor transplantation conference in Boston will create additional awareness about GraftAssure technology and its differentiation and potential applicationsiMDx to also announce sponsorship of a grant for researchers to evaluate economics of in-house, transplanted-organ-rejection testing NASHVILLE, Tenn., June 09, 2026 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., (NASDAQ:IMDX), (iMDx), today announced it will be highlighting its GraftAssure™ technology at the upcoming American Transplant Congress, to be held in Boston fro

Progressing toward commercialization with third-party head-to-head data publications and GALACTIC registry study engagementNortheast kidney transplant center (among the top 10 in the U.S.) is first to sign clinical trial agreement to participate in GALACTIC studyBooked research-use-only purchase by E.U. transplant center and APAC purchase expected in coming daysAnticipate significant U.S. orders to follow FDA marketing authorizationEncouraging dialogue with FDA supports expected authorization later in 2026 NASHVILLE, Tenn., May 13, 2026 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., iMDx, (NASDAQ:IMDX), today published the following letter to shareholders in conjunction with its

NASHVILLE, Tenn., May 06, 2026 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., (NASDAQ:IMDX), (iMDx), today announced that it will report first quarter 2026 financial results after the market closes on Wednesday, May 13, 2026, then 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 Q1 2026 Earnings Webinar. An archived replay will be available after the call concludes on iMDX's website within the Investors/Events & Presentations section here. About Insight Molecular Diagnostics Inc.Insight Molec

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

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

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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

NASHVILLE, Tenn., May 06, 2026 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., (NASDAQ:IMDX), (iMDx), today announced that it will report first quarter 2026 financial results after the market closes on Wednesday, May 13, 2026, then 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 Q1 2026 Earnings Webinar. An archived replay will be available after the call concludes on iMDX's website within the Investors/Events & Presentations section here. About Insight Molecular Diagnostics Inc.Insight Molec

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

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

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