Diasorin’s fully customizable gastrointestinal panel cleared by FDA
The US Food and Drug Administration (FDA) has granted Diasorin 510(k) clearance for the LIAISON PLEX Gastrointestinal Flex Assay, a fully customizable syndromic testing panel capable of detecting a market-leading 24 gastrointestinal pathogen targets.
The new panel expands Diasorin’s growing LIAISON PLEX assay portfolio, which also includes a customizable respiratory assay and three blood culture panels.
The LIAISON PLEX Gastrointestinal Flex Assay rapidly detects a wide range of gastrointestinal pathogens, including bacterial, viral, and parasitic targets, empowering clinicians to make timely, targeted treatment decisions. The Diasorin panel provides truly comprehensive coverage, with particularly broad detection of clinically relevant parasites including Microsporidia, Dientamoeba fragilis, and Strongyloides stercoralis.
Using Diasorin’s proprietary Flex Software, laboratories can tailor testing panels based on seasonality, clinical presentation, current clinical guidelines, recent patient travel history, or immune status. This flexibility allows healthcare teams to design fully customized panels and pay only for the targets they choose, helping to reduce unnecessary testing, support more informed treatment decisions, and improve patient management while enhancing healthcare operational efficiency. The flexibility becomes even more relevant for a broad gastrointestinal panel which includes 24 targets where target selection can align testing with the patient’s specific clinical scenario.
