Diasorin (FTSE MIB: DIA) has submitted a 510(k) premarket notification to the U.S. FDA for its LIAISON PLEX Gastrointestinal Flex Assay — the newest test in its next-generation multiplex molecular diagnostics platform designed for customizable, sample-to-answer syndromic workflows.
The new assay is built to support faster, more informed clinical decisions by enabling rapid detection of common gastrointestinal pathogens. Notably, the panel offers one of the broadest parasite detection capabilities in the market, giving it a competitive edge.
With Diasorin’s proprietary Flex Software, laboratories can personalize their testing panels and pay only for selected targets. This allows them to align assays with evolving clinical guidelines and adapt to factors such as a patient’s travel history, dietary exposures, seasonal trends, clinical symptoms, and immune status. The flexibility of the platform aims to minimize unnecessary testing, better guide treatment choices, and enhance both patient care and operational efficiency.
“Diagnostic stewardship is increasingly critical as clinical laboratories navigate financial pressures and personnel shortages. Diasorin is committed to easing this burden by expanding its portfolio of flexible syndromic testing solutions,” said Angelo Rago, President of Luminex. “This panel will complete the major offering of flexible syndromic testing solutions on the LIAISON PLEX, and we believe it will broaden our reach to potential hospital lab customers, accelerating the platform’s impact.”
Following FDA clearance, the Gastrointestinal Flex Assay will expand Diasorin’s portfolio of FDA-cleared syndromic tests, which already includes the LIAISON PLEX Respiratory Flex Assay, LIAISON PLEX Yeast Blood Culture Assay, LIAISON PLEX Gram-Negative Blood Culture Assay, and LIAISON PLEX Gram-Positive Blood Culture Assay.
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