Diasorin announced the submission of a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its LIAISON PLEX Gastrointestinal Flex Assay, the latest addition to its next generation multiplex molecular diagnostics platform for customizable, sample-to-answer syndromic testing.
The LIAISON PLEX Gastrointestinal Flex Assay empowers clinicians to make timely, targeted treatment decisions by rapidly detecting common gastrointestinal pathogens.
Using Diasorin’s proprietary Flex Software, laboratories can create custom panels and pay only for the targets they need, tailoring tests to the latest clinical guidelines as well as to the patient’s travel history, food exposure, seasonality, clinical presentation, and immune status.
The combination of Flex technology with the Gastrointestinal Assay’s numerous targets, will help to reduce unnecessary testing, guide better treatment decisions, and improve both patient management and healthcare operational efficiency.
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