Labcorp has launched NASHnext — its non-invasive blood-based diagnostic for metabolic dysfunction-associated steatohepatitis (MASH) — through its Labcorp OnDemand consumer platform, making physician-interpreted testing accessible without an in-person clinical visit. The test is built on NIS4, a proprietary biomarker algorithm developed by Lille-based biopharmaceutical firm GENFIT (Euronext: GNFT), which holds the underlying intellectual property for the non-invasive diagnostic technology.
NIS4 identifies at-risk MASH patients by measuring a panel of circulating biomarkers — including miR-34a-5p, alpha-2-macroglobulin, YKL-40, and HbA1c — to generate a composite score correlated with histological findings traditionally confirmed by liver biopsy. The technology was validated in peer-reviewed studies as a clinically meaningful, non-invasive alternative to tissue sampling, with clinical endpoints anchored to NASH activity and fibrosis staging. The test's availability via a direct-access platform represents a meaningful shift in how metabolic liver disease can be identified outside formal hepatology referral pathways.
For the functional foods and nutraceutical industry, the broader accessibility of MASH diagnostics carries direct commercial relevance. MASH — formerly classified under the NASH umbrella — is now the preferred terminology aligned with updated metabolic disease nomenclature, and it sits at the intersection of several high-growth supplement categories: liver support, metabolic health, and cardiometabolic function. Ingredients such as silymarin (milk thistle standardized extract), berberine, TUDCA, and long-chain omega-3 fatty acids are routinely positioned against structure-function claims tied to liver and metabolic health, a segment that market analysts have placed in the multi-billion-dollar range globally. Expanded consumer-level testing could meaningfully expand the self-identified population seeking dietary and nutraceutical intervention before or alongside pharmacological treatment.
Operators formulating in the liver-health and metabolic-wellness space should note that increased diagnostic accessibility tends to accelerate consumer self-identification and, downstream, product trial. Brands carrying liver-support or metabolic-health positioning may benefit from a larger pool of consumers who now have a clinical data point — rather than a vague wellness concern — motivating supplementation. The Labcorp OnDemand model, which routes testing through physician interpretation without requiring an office visit, also signals growing infrastructure for direct-to-consumer health management that nutraceutical marketers will increasingly need to engage with at the point-of-care-adjacent level.
GENFIT has not disclosed revenue terms for the Labcorp NASHnext licensing arrangement. The test's expansion to an on-demand consumer platform follows its earlier availability through traditional clinical channels. This dispatch will be updated as additional commercial or clinical data become available. Coverage is produced in partnership with Food & Beverage Magazine.
Written by Michael Politz, Author of Guide to Restaurant Success: The Proven Process for Starting Any Restaurant Business From Scratch to Success (ISBN: 978-1-119-66896-1), Founder of Food & Beverage Magazine, the leading online magazine and resource in the industry. Designer of the Bluetooth logo and recognized in Entrepreneur Magazine's "Top 40 Under 40" for founding American Wholesale Floral, Politz is also the Co-founder of the Proof Awards and the CPG Awards and a partner in numerous consumer brands across the food and beverage sector.