Welcome to our dedicated page for Insight Molecular Diagnostics news (Ticker: IMDX), a resource for investors and traders seeking the latest updates and insights on Insight Molecular Diagnostics stock.
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 (IMDX) will participate in the Lake Street Capital Markets 10th Annual Best Ideas Growth “BIG10” Conference on September 10, 2026, in New York City.
The event at the Metropolitan Club will feature one-on-one meetings with IMDX’s CEO Josh Riggs and CFO Andrea James. Interested investors are asked to contact their Lake Street sales representative to arrange meetings.
Insight Molecular Diagnostics (Nasdaq: IMDX) will host a virtual key opinion leader event on August 17, 2026 at 11:00 a.m. ET to discuss its GraftAssure dd-cfDNA platform for transplanted organ health monitoring. Cardiologist Max Jacob Liebo, MD will join iMDx executives Nick Ioannou, MD, MHA and CEO Josh Riggs.
The event will review GraftAssureDx, an in vitro diagnostic kit currently under FDA review for kidney transplant rejection testing and potential in-house heart transplant rejection monitoring. iMDx will also outline its broader GraftAssure product portfolio and envisioned shifts toward faster, local dd-cfDNA testing using digital PCR technology.
Insight Molecular Diagnostics (Nasdaq: IMDX) reported Q2 2026 revenue of approximately $239,000, largely from laboratory services, plus $21,000 from research-use-only kits, and gross profit of $157,000, a 65.7% gross margin. Net loss was $11.3 million, or $0.31 per share, and adjusted net loss was $8.3 million, or $0.23 per share.
Operating expenses were $11.6 million, including $2.3 million non-cash contingent consideration, $661,000 stock-based compensation, and $641,000 depreciation and amortization. Non-GAAP operating expenses decreased 13% sequentially but rose 26% year over year. Adjusted EBITDA loss was $7.8 million. IMDX ended Q2 with $18.7 million in cash, cash equivalents and restricted cash and outgoing free cash flow of about $10 million.
The company highlighted timely FDA review progress for its GraftAssureDx kidney transplant test kit, favorable Medicare reimbursement changes for dd-cfDNA surveillance and treatment-response monitoring, and multiple peer-reviewed clinical studies showing strong performance and head-to-head analytical data for GraftAssure.
Insight Molecular Diagnostics (Nasdaq: IMDX) will release its second quarter 2026 financial results after the market close on Monday, August 10, 2026. Management will host a live Zoom webinar at 2:00 pm PT / 5:00 pm ET, with Q&A and an archived replay available on the company’s investor website.
On August 11, 2026, CEO Josh Riggs and CFO Andrea James will participate in the 11th Annual Needham Virtual MedTech & Diagnostics 1x1 Conference, holding virtual one-on-one meetings with registered investors who schedule via their Needham sales representative.
Insight Molecular Diagnostics (Nasdaq: IMDX) reported that a new study in Lancet Regional Health – Europe, extending a 2024 Phase 2 felzartamab trial, used its GraftAssure donor-derived cell-free DNA (dd-cfDNA) assay to guide treatment of antibody-mediated rejection (AMR) in kidney transplant patients.
According to iMDx, dd-cfDNA–guided management enabled serial monitoring, appeared to spare roughly two-thirds of drug use versus fixed four‑weekly dosing, and showed prolonged, safe treatment in this small cohort. The company also received MolDX confirmation of Medicare reimbursement for kidney transplant rejection treatment response monitoring with dd-cfDNA, supporting use of GraftAssureCore LDT, while GraftAssureDx remains under FDA review and certain products are still limited to investigational use.
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.