FDA-Cleared Gastrointestinal Panel Detects 24 Pathogen Targets

Laboratories must also balance diagnostic stewardship, turnaround times, and healthcare costs when ordering syndromic molecular tests. A newly FDA-cleared test now provides customizable gastrointestinal pathogen testing across 24 targets in a single panel.

Diasorin (Saluggia, Italy) has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the LIAISON PLEX Gastrointestinal Flex Assay, a fully customizable syndromic testing panel that detects 24 gastrointestinal pathogen targets. The assay expands the LIAISON PLEX portfolio, which also includes a customizable respiratory assay and three blood culture panels. It is intended to empower timely, targeted treatment decisions by rapidly detecting bacterial, viral, and parasitic pathogens.

Unlike other sample-to-answer molecular solutions, the LIAISON PLEX Gastrointestinal Flex Assay offers comprehensive coverage with particularly broad detection of clinically relevant parasites, including Microsporidia, Dientamoeba fragilis, and Strongyloides stercoralis. Using Diasorin’s Flex Software, laboratories can tailor target selection to seasonality, clinical presentation, current clinical guidelines, recent patient travel history, or immune status. This approach allows customized panel design aligned to individual clinical scenarios.

In addition, laboratories pay only for the selected targets, which can help reduce unnecessary testing, support more informed treatment decisions, and improve patient management while enhancing operational efficiency. For a broad panel that comprises 24 targets, this flexibility enables alignment of testing with the patient’s specific needs. The panel also supports diagnostic stewardship, accelerates turnaround times, and helps control healthcare costs.

The LIAISON PLEX Gastrointestinal Flex Assay joins the FDA-cleared LIAISON PLEX Respiratory Flex Assay and three blood culture assays—Yeast, Gram-Negative, and Gram-Positive—completing the core LIAISON PLEX panel portfolio. This panel portfolio meets the main laboratory needs for syndromic molecular testing. It further strengthens Diasorin’s positioning in this technology segment.

“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.”