Anvil Diagnostics, Inc.

Anvil Diagnostics, Inc.

Anvil Diagnostics spun out of Rice University in 2022 to dramatically expand the multiplexing of commercial dPCRs for direct-from-blood pathogen diagnostics in hospital settings. Anvil will first launch its MycoScan™ assay in 2026 - a reagents and software package - that enables pan-fungal differentiation from cell-free DNA in plasma. With dPCR well adopted in settings managing patients at disproportionate risk of fungal infections (cancer & transplant centers, academic hospitals), Anvil brings a solution that can be readily accessed as an RUO assay as it continues development towards FDA clearance. As a pre-seed startup, Anvil has raised $2M in funding, initiated on-site pilots with 3 different hospitals testing its beta assay, and rallied significant support from major dPCR platform providers. Invasive fungal infections have 50-80% mortality rates, yet standard-of-care diagnostics either rely on invasive sampling and culture with about 50% yield and long turnaround times, or <10% yield from blood. There are no FDA-cleared blood tests on the market that resolve pathogen species, forcing clinicians to use multiple send-out tests with incomplete coverage. Clinicians rely on positive diagnoses before prescribing antifungals due to their severe toxicity and dangerous interactions with many drugs. MycoScan will enable reliable, noninvasive, and fast fungal testing with hardware that many hospitals have, combining the simplicity and accessibility of PCR with the breadth of DNA sequencing. Anvil has also demonstrated cross-application to bacterial testing and envisions a suite of simple liquid biopsies that help hospitals manage infections at all phases in critical care. Anvil's first product, MycoScan, is a minimally invasive pan-fungal blood test capable of identifying 41+ fungal species from plasma with a turnaround time of <4 hours. It addresses a critical unmet need in laboratory medicine: the diagnosis of invasive fungal infections (IFIs) in hospitalized immunocompromised patients, where current diagnostics detect fewer than 10% of early cases from blood alone. MycoScan will initially be released as a research use-only product, which can be rapidly validated by hospital mycology laboratories to best serve patients in need. Anvil has no subsidiaries and is currently pre-revenue.

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