The new testing panel detects 24 targets and allows laboratories to tailor tests based on patient clinical needs.
Diasorin has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Liaison Plex Gastrointestinal Flex Assay, a customizable syndromic testing panel designed to detect 24 gastrointestinal pathogen targets.
The assay detects a range of bacterial, viral, and parasitic targets. According to the company, the panel provides comprehensive coverage, including the detection of parasites such as Microsporidia, Dientamoeba fragilis, and Strongyloides stercoralis.
The system uses proprietary software that allows laboratories to customize testing panels based on factors such as seasonality, clinical presentation, recent patient travel history, or immune status. This approach enables healthcare teams to design panels and pay only for the specific targets they choose, which may help reduce unnecessary testing and improve operational efficiency, according to a press release from Diasorin.
“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,” says Angelo Rago, president of Luminex, in a release. “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 gastrointestinal assay joins the company’s existing portfolio of cleared flexible syndromic tests. This menu includes the Liaison Plex Respiratory Flex Assay and blood culture panels for yeast, gram-negative, and gram-positive infections.
