Diasorin said the FDA granted 510(k) clearance for a customizable syndromic GI pathogen PCR panel built for its Liaison Plex platform. The Liaison Plex Gastrointestinal Flex Assay detects 24 bacterial, viral, and parasitic targets, with added coverage for organisms not commonly included on competing GI panels. The cleared menu is designed to be tailored through the assay’s Flex software, enabling laboratories to adjust target content based on seasonality, patient presentation, guidelines, and travel history. Diasorin said the instrument also completes the core Liaison Plex GI portfolio, following earlier Respiratory Flex clearance. Strategically, the filing reflects Diasorin’s stated push toward decentralization and point-of-care-style testing economics, as labs seek faster, higher-stewardship panel selection under tighter reimbursement and staffing constraints.
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