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DiaSorin Gets 510(k) Clearance for Liaison Plex Molecular Instrument, Respiratory Assay

NEW YORK – DiaSorin said on Sunday that it has received US Food and Drug Administration 510(k) clearance for a fully automated molecular diagnostics instrument that offers flexible multiplex testing.

The agency also cleared a respiratory panel for use with the instrument.

Saluggia, Italy-based DiaSorin said its Liaison Plex platform provides labs the ability to customize their syndromic panels and adjust for seasonal changes and clinical guidance updates. That flexibility helps labs avoid the expenses of over-testing through fixed syndromic panels, the firm said.

The first panel for the instrument, the Liaison Plex Respiratory Flex Assay, which also was cleared by the FDA, is used to identify up to 14 viral targets and five bacterial targets in nasopharyngeal swab samples. DiaSorin noted that the panel is the first of five that the firm announced in 2023 were under development along with the firm's yeast, Gram-positive, and Gram-negative blood culture panels and a gastrointestinal panel that will be submitted for FDA clearances in 2024 and 2025.

The Liaison Plex was originally named Verigene II, and it is a replacement for the Verigene I system. Both instruments were designed by Luminex, which DiaSorin acquired in 2021 for $1.8 billion.

The Liaison Plex, like its predecessor Verigene system, incorporates nanoparticle chemistry technologies and allows labs to use direct DNA detection or PCR amplification to give the best performance for each sample type, according to the company's website.