Diasorin receives FDA 510(K) Clearance for the LIAISON PLEX Blood Culture Yeast Assay on the new multiplexing LIAISON PLEX

June 6, 2024
It is the second multiplexing molecular diagnostic panel on the LIAISON PLEX to be cleared by the U.S. FDA after the Respiratory Flex Assay, which received clearance in March 2024.

Diasorin announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the company’s new LIAISON PLEX Yeast Blood Culture (BCY) Assay, the second molecular multiplexing panel on the LIAISON PLEX system.

The LIAISON PLEX Yeast Blood Culture Assay represents the first of three multiplex blood culture panels for the microbiological diagnosis of bloodstream infections on the new multiplexing platform of the Group and detects 16 pathogens commonly associated with fungemia (fungal bloodstream infections).

The LIAISON PLEX system is designed to provide increased testing flexibility, and the addition of the LIAISON PLEX Yeast Blood Culture Assay, which is driven by Gram stain, further complements this goal. For ease of use, the fully automated, sample-to-answer system relies on a streamlined workflow and room-temperature consumables. The hands-on time to operate the system is just two minutes, and results are produced in less than two hours.

Diasorin release