Gastrointestinal Flex Assay Gains EU Certification for Tailored Pathogen Testing

Fixed syndromic panels may be broader than necessary when testing is not tailored to a patient’s clinical presentation. A newly certified assay now enables customizable sample-to-answer gastrointestinal pathogen testing for laboratories in Europe.

The LIAISON PLEX Gastrointestinal Flex Assay from Diasorin has received CE certification under the European In Vitro Diagnostic Medical Devices Regulation (IVDR). The certification enables Diasorin to introduce its LIAISON PLEX Flex Testing approach to the European market. The assay is designed to move beyond a traditional fixed-panel model by allowing testing to be adapted to the clinical scenario.

The LIAISON PLEX Gastrointestinal Flex Assay is a multiplex molecular test that can detect up to 24 gastrointestinal pathogen targets. These include bacterial, viral, and parasitic pathogens. Using Diasorin’s proprietary Flex Software, laboratories can tailor testing based on clinical presentation, seasonality, clinical guidelines, travel history, and immune status.

The assay complements the LIAISON PLEX Respiratory Flex Assay, which was also recently CE certified under IVDR. The respiratory assay detects up to 19 bacterial and viral respiratory targets in a customizable format. Both assays run on the LIAISON PLEX System, Diasorin’s automated, sample-to-answer molecular diagnostic platform designed for customizable syndromic testing.

With both assays now IVDR CE certified, Diasorin intends to introduce its Flex Testing approach to European laboratories in Q1 2027. The assays are designed to provide the breadth of a comprehensive syndromic panel while allowing laboratories to select, analyze, and report only targets that are clinically appropriate for each testing algorithm or patient scenario. This approach is intended to support syndromic infectious disease testing across gastrointestinal and respiratory applications.

“Healthcare systems are asking diagnostics to deliver more clinical value while using resources more appropriately. With the IVDR CE certification of our Gastrointestinal Flex Assay, together with our Respiratory Flex Assay, we are bringing European laboratories a fundamentally different approach to syndromic testing: the breadth of multiplex testing with the flexibility to adapt the test to the patient and the clinical question. We believe this can help reduce unnecessary and repeated testing and associated cost, support diagnostic stewardship and contribute to more sustainable healthcare delivery,” said Angelo Rago, President of Luminex.