The Liaison Plex Gastrointestinal Flex Assay detects 24 targets and offers broad parasite coverage with pay-per-target flexibility.
DiaSorin has submitted a 510(k) premarket notification to the US Food and Drug Administration (FDA) for its Liaison Plex Gastrointestinal Flex Assay, a customizable molecular diagnostic panel that detects 24 gastrointestinal pathogens.
The assay runs on DiaSorin’s Liaison Plex multiplexing molecular diagnostic platform and is designed to provide sample-to-answer syndromic testing. A key feature of the panel is its broad parasite coverage, which the company says differentiates it from most other market solutions.
Using DiaSorin’s proprietary Flex Software, laboratories can create custom panels and pay only for the targets they need, according to a release from the company. This approach allows labs to tailor tests based on clinical guidelines, patient travel history, food exposure, seasonality, clinical presentation, and immune status.
The customization capability is intended to help reduce unnecessary testing, guide treatment decisions, and improve patient management while enhancing healthcare operational efficiency.
“Diagnostic stewardship is increasingly critical as clinical laboratories navigate financial pressures and personnel shortages. DiaSorin is committed to easing this burden by expanding its portfolio of flexible syndromic testing solutions,” says Angelo Rago, president of Luminex, in a release. “This panel will complete the major offering of flexible syndromic testing solutions on the Liaison Plex, and we believe it will broaden our reach to potential hospital lab customers, accelerating the platform’s impact.”
Completing the LIAISON PLEX Portfolio
Once cleared, the gastrointestinal panel will join DiaSorin’s existing menu of FDA-cleared syndromic tests on the Liaison Plex platform. Current offerings include the Liaison Plex Respiratory Flex Assay and three blood culture assays targeting yeast, gram-negative bacteria, and gram-positive bacteria.
The addition of the gastrointestinal panel will complete what DiaSorin describes as the major Liaison Plex portfolio, covering the three primary syndromic testing areas: respiratory, blood culture, and gastrointestinal pathogens.
DiaSorin, headquartered in Italy, operates across five continents through 31 companies, four branches, 10 manufacturing facilities, and nine research and development centers. The company has been developing diagnostic reagent kits for more than 50 years and expanded into life sciences in 2021.
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