SEC Form 10-Q filed by Insight Molecular Diagnostics Inc.
$IMDX
Biotechnology: In Vitro & In Vivo Diagnostic Substances
Health Care
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IMDX to host symposium on Wednesday, September 24th to discuss GraftAssureIQ™ at International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDMCT) annual meetingPresenting on GraftAssureIQ at symposium on Thursday, October 9th at the American Society of Histocompatibility and Immunogenetics (ASHI) annual meeting NASHVILLE, Tenn., Sept. 24, 2025 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., (NASDAQ:IMDX), (iMDx), today announced attendance at two key industry conferences where it will discuss its GraftAssure™ technology, including its clinical kitted test under development. At the 23rd IATDMCT annual meeting, which is being held September 21st to 24t
5,000-participant, multi-center registry supported by iMDx's central lab and transplant center partnersNew hospital-based data seeks to further differentiate pending kitted assay that measures biomarker for transplanted organ rejection (dd-cfDNA)Novel registry expected to collect approximately 50,000 samples over three years for organ rejection assay combining both percent and total donor derived cell-free DNA into one scoreRegistry expected to assess utility of "the Berlin protocol" of accelerated testing for certain patients at high risk for organ rejectionRegistry program is incremental, complementary and symbiotic to iMDx "kitted strategy" NASHVILLE, Tenn., Sept. 08, 2025 (GLOBE NEWSW
iMDx's ClinicalTrials.gov listing now names 10 leading transplant centers, up from 5 previouslyGraftAssureDx remains on track for FDA submission by end of 2025, commercial launch in 2026 NASHVILLE, Tenn., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics, or iMDx, (NASDAQ:IMDX), today announced that it is actively enrolling patients in its clinical trial to assess GraftAssureDx and that last week, it enrolled the first patient. In addition, the official clinical trial listing now names 10 leading transplant centers, up from five previously. The ongoing clinical trial is an important step toward obtaining regulatory authorization to deliver an organ transplant r
8-K - Insight Molecular Diagnostics Inc. (0001642380) (Filer)
S-8 - Insight Molecular Diagnostics Inc. (0001642380) (Filer)
10-Q - Insight Molecular Diagnostics Inc. (0001642380) (Filer)
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