Diasorin Receives 510(k) Clearance for Fully Customizable Liaison Plex Gastrointestinal Flex Assay

Original from: Diasorin

Diasorin (FTSE MIB: DIA) announced today that it has received 510(k) clearance from the US Food and Drug Administration (FDA) 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. Unlike other sample-to-answer molecular solutions, 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.

“While clinical guidelines support testing based on patient presentation, current technologies often force laboratories to choose between panels that are either too narrow or too broad,” said Angelo Rago, President of Luminex. “Diasorin’s LIAISON PLEX Gastrointestinal Flex Assay addresses this challenge with a value-driven solution that delivers fast, accurate results with the flexibility needed to optimize diagnostic stewardship, help improve patient outcomes, and manage healthcare costs more effectively.”

The LIAISON PLEX Gastrointestinal Flex Assay joins Diasorin’s menu of FDA-cleared flexible syndromic tests, including 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. This panel portfolio meets the main laboratory needs for syndromic molecular testing and further strengthens Diasorin’s positioning in this technology segment.

Source: Diasorin Receives 510(k) Clearance for Fully Customizable Liaison Plex Gastrointestinal Flex Assay