Diasorin Receives FDA 510(k) Clearance For The Liaison Plex® Blood Culture Yeast Assay On The New Multiplexing Liaison Plex®

Original from: Diasorin

Diasorin today announces 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). Fungal pathogens are often seen as an emerging threat and are of great concern due to the ease with which they can spread between patients in healthcare settings.

“This FDA clearance further exemplifies the momentum of the LIAISON PLEX® System” said Angelo Rago, President of Luminex. “The LIAISON PLEX® Yeast Blood Culture Assay adds to our already market-leading bloodstream infection portfolio to provide a rapid solution for this critical disease state. The LIAISON PLEX® enables clinical labs and healthcare systems throughout the U.S. to meet their diagnostic and antimicrobial stewardship needs for better patient outcomes.”

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. Testing only the pathogens noted on Gram stain helps laboratories avoid the costly over-testing that can occur when labs must use the same broad syndromic panels for all patients. 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.

“The clearance of the LIAISON PLEX® Yeast Blood Culture Assay marks another milestone for Diasorin in strengthening its unique positioning in the growing multiplexing industry” commented Carlo Rosa, CEO of Diasorin. “We are strongly committed to continue expanding our multiplexing offering on our newly launched LIAISON PLEX® system, which will allow laboratories to adopt this technology with an innovative flexing pricing model, paying only for test results for targets of interest.”

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Source: Diasorin Receives FDA 510(k) Clearance For The Liaison Plex® Blood Culture Yeast Assay On The New Multiplexing Liaison Plex®