Insight Molecular Diagnostics Inc.
Key statistics
from XBRL data in SEC filingsAI briefing
from the latest 10-K, 10-Q and 8-K eventsInsight Molecular Diagnostics (iMDx) is a pre-commercial molecular diagnostics company seeking FDA authorization for a kitted donor-derived cell-free DNA transplant rejection test, GraftAssureDx.
What they do
iMDx develops molecular diagnostic tests for transplanted organ rejection monitoring, built around the dd-cfDNA biomarker. The GraftAssure family includes GraftAssureCore (an LDT reimbursed by CMS and run at the company's CLIA-certified Franklin, Tennessee lab), GraftAssureIQ (an RUO kit sold for non-clinical use), and GraftAssureDx (an IVD kit in development for clinical use). The assays run on a digital PCR instrument manufactured by Bio-Rad, with which iMDx has a global strategic partnership. Kitted clinical tests require FDA marketing authorization in the U.S. and IVDR approval in the EU before clinical use.
Revenue drivers
- GraftAssureCore LDT — Laboratory-developed test performed at the Franklin, Tennessee CLIA lab and reimbursed by CMS; the company's currently marketed clinical offering.
- GraftAssureIQ RUO kits — Research-use-only kits sold for non-clinical applications; first kits were sold to a research laboratory customer in May 2025.
- GraftAssureDx IVD kit — Not yet revenue-generating; submitted to FDA on March 25, 2026 and pending marketing authorization, which is required before U.S. clinical sales.
- Testing services / specimen collection — A February 20, 2026 Specimen Collection Agreement with a national reference lab provider supports collection, handling, processing, and delivery of specimens for GraftAssureCore testing.
Recent performance
Annual revenue was $4.1M in 2025, up from $1.9M in 2024 and $1.5M in 2023. Quarterly revenue has been uneven: $260,000 in Q3 2025, $1.1M in Q4 2025, $32,000 in Q1 2026, and $239,000 in Q2 2026. Net loss was $50,222 in 2025 versus $60,663 in 2024, and operating cash flow was negative $22.2M in 2025. As of June 30, 2026, the company reported total assets of $29.4M, total liabilities of $50.7M, shareholder equity of negative $21.3M, and cash and equivalents of $17.8M. The company reported an accumulated deficit of $400.8M as of December 31, 2025.
Strategy
The primary near-term priority is FDA marketing authorization for GraftAssureDx, the kitted version of the transplant rejection monitoring assay. iMDx is pursuing a decentralized model in which hospitals, transplant centers, and labs run tests in-house rather than using send-out central laboratory testing. It partners with Bio-Rad, whose digital PCR instrument the GraftAssure assays run on and which has invested in iMDx. The company also signed a specimen collection agreement with a national reference lab in February 2026 and states that most major U.S. reference labs are interested in adopting in-house dd-cfDNA testing. Management frames revenue growth as dependent on regulatory clearance and subsequent kitted product distribution.
Risks
- No FDA authorization yet — GraftAssureDx kitted tests cannot be used in a clinical treatment setting in the U.S. until FDA marketing authorization is obtained, and the FDA requested additional information in late July 2026.
- History of losses and negative cash flow — The company has incurred operating losses since inception in September 2009, with a $400.8M accumulated deficit as of December 31, 2025, and expects continued losses.
- Financing dependence — iMDx has historically funded operations through outside capital, primarily sales of common stock, and may need to issue additional equity or debt on potentially unfavorable terms.
- Uneven and small revenue base — Quarterly revenue fell to $32,000 in Q1 2026 after $1.1M in Q4 2025, and the currently marketed clinical product is limited to the GraftAssureCore LDT and RUO kit sales.
Outlook
Management said the FDA completed the current phase of its substantive review of GraftAssureDx in late July 2026 and requested additional information, which management views as typical and as occurring in the later stages of review. The company expects continued dialogue with the agency and describes a clear, well-defined set of remaining items. Management also cited a favorable Medicare reimbursement policy issued in July 2026 that it says significantly increases the GraftAssureDx surveillance testing opportunity. iMDx states that most major U.S. reference labs are interested in adopting in-house dd-cfDNA testing, though clinical kit sales remain contingent on authorization.