Summary: Diasorin received FDA 510(k) clearance for the LIAISON PLEX Yeast Blood Culture Assay, enhancing its diagnostic capabilities for bloodstream infections by detecting 16 fungal pathogens.

Takeaways:

  1. The LIAISON PLEX Yeast Blood Culture Assay, the second molecular multiplexing panel on the LIAISON PLEX system, has received 510(k) clearance from the FDA.
  2. The assay can detect 16 common pathogens associated with fungal bloodstream infections, aiding in the diagnosis and management of these infections in healthcare settings.
  3. The system provides rapid results in less than two hours with minimal hands-on time, offering laboratories increased testing flexibility and a cost-effective, streamlined workflow.

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

LIAISON PLEX Yeast Blood Culture Assay

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” says 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. 

Further reading: Diasorin Gets FDA 510(k) Clearance for New Multiplexing Platform

“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” says 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.”