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DiaSorin’s new yeast blood culture assay receives FDA clearance

DiaSorin has announced that its LIAISON PLEX® Yeast Blood Culture (BCY) Assay has received 510(k) clearance from the US Food and Drug Administration (FDA). This marks the second molecular multiplexing panel to be cleared for the company’s LIAISON PLEX® system, following the clearance of the Respiratory Flex Assay in March 2024.

Rapid detection of fungal pathogens

The LIAISON PLEX Yeast Blood Culture Assay is designed to detect 16 pathogens commonly associated with fungemia. This capability is particularly crucial given the growing concern surrounding fungal pathogens and their potential for rapid spread in healthcare settings.

Angelo Rago, President of Luminex, stated: “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.”

Streamlined workflow and increased flexibility

The assay is part of DiaSorin’s strategy to provide increased
testing flexibility. By allowing testing based on Gram stain
results, laboratories can potentially avoid costly over-testing associated with broad syndromic panels.

Key features of the LIAISON PLEX system include:
– Fully automated, sample-to-answer workflow
– Room-temperature consumables
– Two-minute hands-on time
– Results in less than two hours

Expanding multiplexing capabilities

Carlo Rosa, CEO of DiaSorin, commented on the significance of this clearance: “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. 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.”

Future developments

The Yeast Blood Culture Assay is the first of three planned multiplex blood culture panels for the LIAISON PLEX system. Clinical laboratory scientists can expect further expansions to DiaSorin’s multiplexing portfolio in the future, potentially offering even greater diagnostic capabilities for bloodstream infections.

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