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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) 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.
Insight Molecular Diagnostics (Nasdaq: IMDX) will report Q4 2025 financial results after market close on March 26, 2026, and will host a live Zoom webinar at 2:00 pm PT / 5:00 pm ET the same day with a Q&A session.
An archived replay will be available in the Investors/Events & Presentations section of the company website. Management will also attend the 25th Annual Needham Virtual Healthcare Conference and present in a virtual fireside chat on April 15, 2026.
Insight Molecular Diagnostics (Nasdaq: IMDX) highlighted a peer-reviewed study of 249 biopsy-matched kidney transplant patients showing its GraftAssure Combination Model (CM) score outperformed percentage-only and absolute dd-cfDNA measures in correlating with four histopathology-derived rejection indices.
The company cites a prior World Transplant Congress readout showing a rise in positive predictive value to over 80% at 25% prevalence, and plans to commercialize an IVD kit in 2026 to address a roughly $2 billion transplant testing market.
Insight Molecular Diagnostics (Nasdaq: IMDX) completed key milestones in February 2026 advancing GraftAssureDx toward an FDA De Novo IVD submission. Milestones include a three-site reproducibility study, collection of sufficient clinical samples based on a projected 25–30% rejection rate, and ISO 13485 certification (Feb. 26).
Internal analytical work is nearly complete: about 11,660 of 12,000 instrument and assay cycles finished (roughly 340 remain). Certification enables planned U.K. and EU submissions and supports commercial manufacturing readiness in 2026.
Insight Molecular Diagnostics (Nasdaq: IMDX) announced a registered direct offering of 4,525,976 shares (or pre-funded warrants) at $5.75 per share, expected to close on February 12, 2026, for approximately $26.0 million gross proceeds before fees. Lake Street Capital Markets is sole placement agent.
The company said it will use net proceeds for general corporate purposes, including research and development to expand its GraftAssure transplant diagnostic offering beyond kidney into other organs, most immediately heart transplant testing. Bio-Rad participated on the same terms.