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Insight Molecular Diagnostics Inc. reports developments for a molecular diagnostics business focused on donor-derived cell-free DNA testing for transplant monitoring. Its recurring updates cover the GraftAssure family of assays, including research-use and in vitro diagnostic kit development, kidney transplant rejection testing, clinical data presented in transplant and renal medicine forums, quality-system certification, and commercial preparation for localized organ health testing.
Company news also includes quarterly financial results, investor presentations, financing activity, partnerships supporting testing workflows, and regulatory activity for transplant diagnostic products.
Insight Molecular Diagnostics (Nasdaq: IMDX) announced that a new MolDX Medicare local coverage determination expands reimbursement for donor-derived cell-free DNA (dd-cfDNA) testing in transplant care, supporting commercial adoption of its GraftAssure assay portfolio.
The final policy increases covered surveillance testing frequencies for kidney and heart transplants versus both the prior and draft policies, including six reimbursable kidney tests and twelve heart tests in year one, and four tests per year in years two and three. It also removes the prior long-term testing ceiling when clinically useful and cites iMDx-affiliated GraftAssure research. According to iMDx, its GraftAssureCore test currently carries a Medicare reimbursement rate of $2,753 per result, which the company expects could later be bridged to the FDA-pending GraftAssureDx kit.
Insight Molecular Diagnostics (Nasdaq: IMDX) announced that Chief Science Officer Prof. Dr. Ekkehard Schuetz has published his 200th scientific article. He co-invented the dd-cfDNA technology behind IMDx’s GraftAssure assays and previously led Chronix Biomedical, acquired in 2021.
With an H-index of 58 and over 11,000 citations, he ranks among the top 2% of laboratory diagnostics researchers and top 2.5% of all researchers worldwide. Under his leadership, IMDx submitted a de novo FDA application for its GraftAssureDx kit, advancing its dd-cfDNA transplant rejection testing strategy.
Insight Molecular Diagnostics (Nasdaq: IMDX) and the American Society of Transplant Surgeons awarded a $100,000 ASTS‑iMDx Health Economics Research Grant to Drs. Kenneth Andreoni and Kenneth Chavin. The study will compare in-house versus send-out dd-cfDNA testing in kidney transplantation and inform commercialization planning for GraftAssureDx, currently under FDA de novo review.
Insight Molecular Diagnostics (Nasdaq: IMDX) reported peer-reviewed head-to-head data on its transplant monitoring test GraftAssure. Clinical Chemistry published a study showing 99.2% agreement with a leading NGS dd-cfDNA assay at the 0.5% kidney rejection-risk threshold.
According to iMDx, GraftAssure showed a 41% reference change value at a 0.17% median dd-cfDNA level and a 0.04% lower limit of quantification, supporting precise longitudinal monitoring. iMDx is commercializing GraftAssure through a CMS-reimbursed LDT and developing the GraftAssureDx kit while pursuing U.S. and EU regulatory pathways.
Insight Molecular Diagnostics (Nasdaq: IMDX) reported that the American Journal of Transplantation published a pre-proof showing its GraftAssure™ CM-Score has superior diagnostic performance to single-metric dd-cfDNA in kidney transplant monitoring.
The CM-Score achieved PPV of 81% and NPV of 91%, showed higher net benefit in decision-curve analysis, and doubled reliability of positive results. IMDX has begun the GALACTIC registry for prospective validation and is seeking FDA marketing authorization for its in-development GraftAssureDx™ IVD kit, while GraftAssureCore™ is currently offered as a reimbursed LDT.
Insight Molecular Diagnostics (Nasdaq: IMDX) will showcase its GraftAssure transplant rejection monitoring technology at the American Transplant Congress in Boston, June 20–24, 2026. Events include presentation of favorable third-party head-to-head data, an IRB session on anti-CD38 therapies, and announcement of ASTS grant winners.
iMDx will also highlight its GraftAssureCore CLIA lab test, GraftAssureIQ research-use kit, and GraftAssureDx in vitro diagnostic kit currently under FDA review.
Insight Molecular Diagnostics (Nasdaq: IMDX) reported Q1 2026 revenue of about $32,000, all from Tennessee lab services, with 46.9% gross margin, and a net loss of $4.3 million ($0.12 per share).
The company advanced GraftAssureDx toward FDA authorization expected later in 2026, initiated GraftAssureIQ research-use-only kit sales in Switzerland and Southeast Asia, secured 34 interested centers for the GALACTIC registry with its first U.S. clinical trial agreement, closed a $26 million registered direct offering, and ended Q1 with $29.4 million in cash and equivalents.
Insight Molecular Diagnostics (Nasdaq: IMDX) will release its first quarter 2026 financial results after market close on May 13, 2026. A live Zoom webinar to discuss results and host Q&A is scheduled for 2:00 pm PT / 5:00 pm ET that day, with registration required. An archived replay will be posted in the Investors/Events & Presentations section of iMDX’s website after the call.
Insight Molecular Diagnostics (Nasdaq: IMDX) will present independent real-world GraftAssure data at EFI2026, ERA Congress and ATC, and will host investor meetings at Needham on April 15, 2026.
The company reported unaudited Q1 2026 cash of $29.4 million, recognized $32,000 in lab services revenue, and submitted GraftAssureDx to FDA via the Class II de novo pathway on March 25, 2026.
Insight Molecular Diagnostics (Nasdaq: IMDX) submitted GraftAssureDx for FDA de novo review on March 25, 2026 and expects a ~150-day review timeline aiming for authorization in 2026. The company closed a $26 million financing in February, received TÜV SÜD ISO 13485 certification Feb 26, and expects U.K. CE marking via self-certification in Q2 2026.
Clinical updates include a second favorable peer-reviewed, multi-center (249 biopsy-matched patients) study and growing engagement with 37 U.S. transplant centers representing >25% of U.S. transplants; Medicare reimbursement for send-out testing is $2,753 per result.