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FDA approval
DiaSorin obtains FDA clearance for Liaison Plex Yeast Blood Culture Assay
Precision Medicine
Jun 5, 2024
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Precision Medicine

Precision Medicine

Jun 5, 2024

DiaSorin obtains FDA clearance for Liaison Plex Yeast Blood Culture Assay

FDA approval

  • DiaSorin has been granted 510(k) clearance by the FDA for its Liaison Plex Yeast Blood Culture Assay. This assay is the second molecular multiplexing panel on DiaSorin's Liaison Plex analyzer, designed to facilitate accurate and efficient detection of fungal infections in blood samples.

  • The assay is claimed to have the ability to recognize 16 common fungal pathogens within hours and is aimed to provide increased testing flexibility of the Liaison Plex and to reduce the cost of over-testing. The automated, sample-to-answer system leverages a room-temperature consumables streamlined workflow to produce results in less than two hours.

  • Headquartered in Italy, DiaSorin specializes in developing, manufacturing, and marketing diagnostic reagent kits and instruments, focusing on immunodiagnostics and molecular diagnostics. DiaSorin’s product portfolio addresses various medical needs, infectious diseases, gastrointestinal diseases, endocrinology, and metabolic disorders. The company’s key offerings include the LIAISON series of immunodiagnostic testing instruments and the LIAISON MDX platform for molecular diagnostics.

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