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Insight Molecular Diagnostics Inc. (IMDX)

Health Care · Molecular diagnostics / transplant rejection monitoring · Nasdaq

iMDx develops decentralized molecular diagnostic kits for transplant organ rejection monitoring using donor-derived cell-free DNA biomarkers, enabling in-house testing at hospitals rather than centralized lab services.

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What Insight Molecular Diagnostics Inc. does

Insight Molecular Diagnostics Inc. (formerly Oncocyte Corporation) is a diagnostics technology company developing molecular diagnostic test kits for organ transplant rejection monitoring and oncology applications. The company's primary focus is decentralized transplant testing through its GraftAssure family of assays, which measure donor-derived cell-free DNA (dd-cfDNA) using digital PCR instruments manufactured by Bio-Rad. iMDx operates a CLIA-certified laboratory in Franklin, Tennessee for clinical testing (GraftAssureCore LDT), develops research-use-only kits (GraftAssureIQ), and is pursuing FDA approval for its clinical IVD kit (GraftAssureDx). The company pursues a business model enabling in-house testing at hospitals and transplant centers rather than centralized send-out laboratory services.

Themes: ["transplant rejection monitoring / organ health","decentralized diagnostics / point-of-care testing","molecular diagnostics / biomarkers","oncology diagnostic testing"]

Fundamentals

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Key risks (from latest filing)

["Regulatory approval dependency: GraftAssureDx requires FDA marketing authorization for clinical use in the U.S. and IVDR approval in the EU, with no guarantee of timely or favorable decisions","Dependence on Bio-Rad partnership: the company's assays rely on Bio-Rad's digital PCR instruments, and disruption of this collaboration could materially impact product development and commercialization","Steep revenue decline and negative profitability: revenue decreased 49.28% year-over-year with a net margin of -2454.64%, indicating substantial operating losses and potential liquidity concerns despite positive stock price momentum"]

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Competitors & peers

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Fundamentals: Finnhub, as of 2026-07-13. Filings: SEC EDGAR. Prices are delayed daily-close data.

Last updated 2026-07-10.

Informational only — NOT financial advice. All figures are delayed daily-close data from SEC EDGAR & Finnhub, shown with their as-of date.