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 (Nasdaq: IMDX) praised a Jan. 13, 2026 STAR working group position paper in the American Journal of Transplantation that calls for decentralized, high-quality dd-cfDNA testing. The company says the paper's endorsement of absolute quantification and onsite testing aligns with iMDx's GraftAssure family of assays and supports demand for its kitted diagnostics. iMDx noted GraftAssureCore is an LDT reimbursed by CMS, GraftAssureDx is an IVD kit in development, and management cited a roughly $1 billion-plus addressable market for kitted transplant rejection testing.
Insight Molecular Diagnostics (Nasdaq: IMDX) announced management will attend investor conferences during JPM Week and BTIG Snowbird in winter 2026. Key events: LifeSci Advisors 15th Annual Corporate Access Event (one-on-one meetings, Jan 12, The Beacon Grand, San Francisco), additional JPM Week investor meetings (one-on-one, Jan 12–14, San Francisco), and BTIG 13th Annual Snowbird (one-on-one meetings and skiing, Feb 9–11, Cliff Lodge, Snowbird, Utah). The company provided contact instructions for scheduling in-person meetings via LifeSci Partners or BTIG sales representatives.
Insight Molecular Diagnostics (Nasdaq: IMDX) appointed Dr. Nick Ioannou as Vice President, Medical Affairs effective Jan 6, 2026. Dr. Ioannou brings more than three decades of clinical and medical-affairs experience across organ transplant, nephrology, cardiology, genetics, and oncology.
The hire positions iMDx to support its upcoming commercial transplant rejection assay launch, leveraging his field-based KOL relationships and prior roles at Guardant Health, Natera, CSL Behring, Fresenius, and Baxter.
Insight Molecular Diagnostics (Nasdaq: IMDX) provided a year-end update on its GraftAssure transplant diagnostics program and regulatory progress on GraftAssureDx. The company said ~95% of its planned FDA IVD de novo submission work was complete at year-end 2025, with final software quality-control items remaining and full submission expected in the coming weeks.
Other highlights: 20 global transplant centers engaged by year-end 2025, 17 U.S. centers committed to a registry (≈10% U.S. transplant volume), TÜV SÜD ISO 13485 stage 1 & 2 audits completed, and an accelerated EU/CE/IVDR submission targeted for H1 2026.
Insight Molecular Diagnostics (Nasdaq: IMDX) reported Q3 2025 results and progress toward a planned FDA submission of GraftAssureDx by year-end 2025 with an anticipated mid-2026 product launch. Key operational items include 11 clinical trial sites, a planned 5,000-participant registry collecting ~50,000 samples, finalized kitted product design, and Bio-Rad supply of instrumentation and certain reagents.
Financially, Q3 revenue was $260,000 from lab services and the company remains essentially pre-revenue for kitted sales. CMS reimbursement for the assay was set at $2,753 per result.
Insight Molecular Diagnostics (Nasdaq: IMDX) will report Q3 2025 financial results after market close on November 10, 2025. The company will host a live Zoom webinar and Q&A at 2:00 PM PT / 5:00 PM ET the same day; registration and an archived replay will be available on the company’s investor relations site.
Separately, CEO Josh Riggs will attend the Stephens NASH25 Conference in Nashville on November 19, 2025 (event runs November 18–20); investors can request one‑on‑one meetings via their Stephens sales representative.
Insight Molecular Diagnostics (Nasdaq: IMDX) named Steven Tahmooressi as Vice President of Marketing to lead global commercialization for its GraftAssure family as the company prepares a kitted clinical launch in 2026.
The company said it plans to submit GraftAssureDx for FDA authorization in 2025; its existing GraftAssureCore LDT is currently reimbursed by Medicare and performed at a CLIA lab in Nashville, and GraftAssureIQ is available RUO. iMDx cites an estimated $1 billion addressable market for kitted transplant rejection testing.
Insight Molecular Diagnostics (Nasdaq: IMDX) reported an American Journal of Transplantation case study where its GraftAssure dd-cfDNA assay monitored a 33-year-old kidney transplant patient treated with CD19 CAR-T therapy.
GraftAssure testing reportedly confirmed absence of rejection while conventional immunosuppression was stopped, with stable graft function and oncologic remission sustained through about 23 months, suggesting a possible "immune reset." The company notes GraftAssureCore is reimbursed by CMS, GraftAssureIQ became available for RUO in summer 2024, and GraftAssureDx is in development with planned FDA submission in 2025; the firm cites a $1 billion addressable market for kitted transplant testing.
Insight Molecular Diagnostics (NASDAQ:IMDX) announced its participation in two major industry conferences to showcase its GraftAssure™ transplant rejection testing technology. The company will host a symposium at the IATDMCT annual meeting in Singapore (September 21-24) and present at the ASHI annual meeting in Orlando (October 6-10).
IMDX will discuss its GraftAssureIQ™ research-use-only test kit and the development of GraftAssureDx™, its clinical kitted test. Both tests measure donor-derived cell-free DNA (dd-cfDNA) for transplant rejection detection. The company plans to submit GraftAssureDx for FDA review by year-end and estimates an addressable market of $1 billion for kitted transplant rejection testing.
Insight Molecular Diagnostics (NASDAQ:IMDX) announced a strategic initiative to launch a novel registry database for its kidney transplant rejection assay. The registry will enroll 5,000 patients across 25+ centers over three years, collecting approximately 50,000 samples. The program will evaluate the company's unique "combined score" algorithm and the "Berlin protocol" for accelerated testing in high-risk patients.
The announcement follows several key milestones in 2025, including claims expansion for dd-cfDNA testing, increased CMS reimbursement to $2,753 for GraftAssureCore, and positive clinical data presented at the World Transplant Congress. The company is targeting an estimated $1 billion addressable market for transplant rejection testing with its GraftAssure™ product line.