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 comm ...

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, diagnosti ...

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 n ...

Core Insights - Insight Molecular Diagnostics Inc. (iMDx) is preparing to submit its first molecular diagnostic test kit, GraftAssureDx™, for FDA approval, with expectations to begin sales in the following year after regulatory authorization [1][3][12] - The company aims to deliver a best-in-class diagnostic test for kidney transplant patients, targeting a market exceeding $1 billion for transplant rejection testing [3][4] - iMDx is focused on a decentralized testing approach, which is expected to enhance patient care and improve access to organ health testing [4][5] Company Developments - iMDx has made significant progress in its FDA submission process, including software development, clinical trial site engagement, and reproducibility testing [14][15][16] - The company is on track to engage 20 transplant centers globally by the end of 2025 and has already achieved favorable head-to-head data for the GraftAssure assay [5][21] - A major strategic initiative includes a 5,000-participant registry program aimed at generating real-world data to validate the clinical utility of the GraftAssure assay [23] Financial Overview - For Q3 2025, iMDx reported revenues of $260,000, primarily from laboratory services, while remaining "pre-revenue" for kitted product sales [34][36] - The company incurred a net loss of $10.9 million for Q3 2025, with operating expenses totaling $11.2 million, reflecting increased investment in the FDA program [36][42] - Cash and cash equivalents at the end of Q3 2025 were $20.2 million, with a net cash used in operating activities of $4.6 million [36][44] Market Position and Future Prospects - iMDx anticipates that regulatory clearance will allow for rapid scaling of its business, aiming for $100 million in annual high-margin revenue with double-digit growth [3][30] - The company is also preparing to expand its testing capabilities beyond kidney transplants to include heart and lung transplant diagnostics [30][33] - The positive coverage decision from the Centers for Medicare & Medicaid Services (CMS) and improved reimbursement rates for the GraftAssure assay are expected to drive clinician engagement and utilization [7][20]

Group 1 - Insight Molecular Diagnostics Inc. (iMDx) announced participation in investor conferences hosted by H.C. Wainwright and Lake Street Capital Markets [1] - The H.C. Wainwright 27th Annual Global Investment Conference will take place on September 8-9, 2025, featuring a company presentation on September 8 at 5:00 pm ET [1] - The Lake Street Capital Markets 9th Annual Best Ideas Growth Conference (BIG9) is scheduled for September 11, 2025, with a format of one-on-one meetings [1] Group 2 - Insight Molecular Diagnostics is focused on democratizing access to novel molecular diagnostic testing to improve patient outcomes [2] - The company holds several trademarks, including GraftAssureCore™, GraftAssureIQ™, GraftAssureDx™, VitaGraft™, GraftAssure™, DetermaIO™, and DetermaCNI™ [2]

Core Insights - Insight Molecular Diagnostics, Inc. (iMDx) aims to democratize access to molecular diagnostics, particularly in transplant monitoring, by developing self-run testing kits for hospitals [3][4][7] - The company recently rebranded from Oncocyte to Insight Molecular Diagnostics to better reflect its mission [4][8] - iMDx's first commercial focus is on measuring donor-derived cell-free DNA to monitor transplanted organ health [4][5] Company Strategy - iMDx is working on a regulatory pathway to obtain FDA clearance for its diagnostic tests, with a submission expected by the end of 2025 and potential clearance in 2026 [6] - The company has a research-use-only version of its kit currently utilized by 10 centers globally [5] - iMDx's strategy includes increasing visibility with investors as it approaches key regulatory milestones [6] Market Position - The company has relocated its headquarters from Irvine, California, to Nashville, Tennessee, and changed its NASDAQ symbol effective June 18, 2025 [8] - iMDx's mission is to improve patient outcomes by making advanced molecular diagnostic testing more accessible [4][7]

Core Insights - Insight Molecular Diagnostics Inc. (iMDx) is progressing towards delivering a regulated kitted transplant monitoring assay, GraftAssureDx, to the market, aiming to capture a share of the $1 billion transplant rejection testing market [1][2][4] Regulatory and Product Development - The company is focused on designing a complex molecular lab test in a kitted form to facilitate localized diagnostic testing, with plans to submit GraftAssureDx for FDA review by the end of 2025 [2][7] - iMDx has made significant strides in its clinical trial, engaging leading transplant hospitals, and has received positive feedback from the FDA during meetings [8][11] - The company aims to democratize access to transplant rejection tests by obtaining regulatory authorization, allowing hospitals to conduct tests independently [4][6] Financial Performance - In Q2 2025, iMDx reported revenues of $518,000, primarily from laboratory services and initial sales of GraftAssureIQ kits, with a gross profit of $350,000, reflecting a gross margin of 67.6% [15][18] - Operating expenses for Q2 2025 totaled $10.2 million, with a net loss of $9.7 million, or ($0.30) per share, indicating ongoing investment in product development and regulatory processes [18][26] Market Strategy and Future Outlook - The company is implementing a "Land and Expand" strategy, starting with research-use-only kits to familiarize hospitals with their assays before transitioning to diagnostic kits upon regulatory approval [9][15] - iMDx is also exploring expansion opportunities beyond kidney transplant testing, including heart, lung, and liver transplant rejection testing, leveraging the same cfDNA platform [12][14] - The company has received a boost in Medicare reimbursement for its flagship technology, GraftAssureCore, which sets a benchmark for future kitted test reimbursement [8][9]

Company Announcements - Insight Molecular Diagnostics, or iMDx, will report its second quarter 2025 financial results after the market closes on August 11, 2025 [1] - A live Zoom webinar will be held on the same day at 2:00 pm PT / 5:00 pm ET to discuss the financial results, followed by a Q&A session [1] - An archived replay of the webinar will be available on iMDx's investor relations website after the call concludes [2] Upcoming Events - CEO Josh Riggs and CFO Andrea James will attend the 10th Annual Needham Virtual MedTech & Diagnostics Conference on August 12, 2025 [3] - The conference will take place virtually from August 11-12, 2025, and investors can book one-on-one meetings with management through their Needham sales representative [3][4] Company Background - Insight Molecular Diagnostics Inc., formerly known as Oncocyte Corp., is focused on democratizing access to novel molecular diagnostic testing to improve patient outcomes [4] - The company moved its headquarters from Irvine, California, to Nashville, Tennessee, in June 2025, with a new NASDAQ symbol effective June 18 [5]