Diasorin’s LIAISON PLEX platform and assay receive FDA clearance

Original from: Medical Device Network

DiaSorin has received the US Food and Drug Administration’s 510(k) clearance for its LIAISON PLEX platform and the accompanying LIAISON PLEX Respiratory flex assay.

The development marks a significant expansion of Diasorin’s offerings in the multiplexing syndromic market.

Initially named VERIGENE II by Luminex, the LIAISON PLEX system introduces a flexible approach to syndromic panel testing.

The platform is designed to provide laboratories with the ability to customise syndromic panels, moving away from the “one size fits all” approach.

This flexibility is particularly beneficial for adjusting to seasonal changes and clinical guidance updates, helping to avoid unnecessary testing.

Said to be fully automated, the new platform requires only two minutes of hands-on time per sample and delivers results in under two hours.

Luminex president Angelo Rago said: “The LIAISON PLEX and its Respiratory Panel will allow clinical laboratories and physicians to tailor tests to the needs of their patient population.

“The LIAISON PLEX is truly a laboratory’s sample-to-customizable answer solution and we believe this will help address the growing demand for diagnostic stewardship, fiscal responsibility, and operational efficiency in clinical labs and healthcare systems throughout the US.”

The LIAISON PLEX assay, which tests for 19 respiratory pathogens that are commonly associated with respiratory infections, demonstrates the platform’s Flex Testing approach that allows for the selection and payment of specific results tailored to a patient’s clinical picture.

The FDA clearance of the LIAISON PLEX Respiratory flex assay is the first step in a series of planned panel releases.

Diasorin CEO Carlo Rosa said: “The clearance of the LIAISON PLEX, along with its first panel, marks a significant and strategic milestone for Diasorin after the Luminex acquisition, delivering to the market an innovative platform that is uniquely positioned in the growing multiplexing industry.

“The flex technology exemplifies our forward-looking approach to diagnostic development, tackling the current limitations of the multiplexing market with a fully automated and customisable panel, and providing customers with the needed flexibility to adopt this technology in a cost-effective manner.”

Diasorin has announced that blood culture and gastrointestinal panels are in development, with submissions to the FDA expected in 2024 and 2025, respectively.

In 2022, the FDA granted 510(k) clearance for DiaSorin’s Simplexa Covid-19 Direct kit.

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Source: Diasorin’s LIAISON PLEX platform and assay receive FDA clearance