Diasorin receives FDA 510(k) clearance for fungal infection panel

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Diasorin has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new Liaison Plex Yeast Blood Culture (BCY) assay, the second molecular multiplexing panel developed for the firm's Liaison Plex system.

The Saluggia, Italy-based firm's Respiratory Flex assay received clearance in March.

The Liaison Plex BCY test detects 16 different pathogens associated with fungal bloodstream infections (also known as fungemia.) According to a statement from Diasorin, the assay is the first of three panels to be developed for identifying and diagnosing bloodstream infections on the Liaison Plex platform.

Fungal infections have been recognized as an emerging threat, due in part to the ease with which they can be transmitted between patients in healthcare settings, the firm noted.

The fully-automated Liaison Plex system uses room-temperature consumables and has a streamlined workflow requiring only two minutes of hands-on time to operate the system, producing results in less than two hours, according to the company.

The Liaison Plex BCY assay utilizes Gram staining. According to Diasorin, testing only the pathogens noted on the Gram stain will limit the overtesting that may occur with the need to use the same broad syndromic panels for all patients.

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