Diasorin received 510(k) clearance from the FDA for a customizable syndromic gastrointestinal pathogen PCR panel designed for its Liaison Plex platform. The Liaison Plex Gastrointestinal Flex Assay detects 24 bacteria, viruses, and parasites and uses Flex software to tailor menu selections by seasonality, clinical presentation, travel history, and immune status. The clearance also adds testing options for pathogens that do not appear on every competing panel, including Microsporidia and Strongyloides stercoralis. Diasorin said the new panel completes the core GI portfolio for Liaison Plex and is intended to improve diagnostic stewardship by reducing overly broad or overly narrow test ordering. The company previously disclosed respiratory syndromic Flex testing clearances and multiple blood culture panels for Liaison Plex systems, positioning the instrument suite for broader adoption across decentralized testing settings.
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