NEW YORK – Diasorin said on Wednesday that the firm has received US Food and Drug Administration 510(k) clearance for a molecular test for common causes of fungemia.
The Saluggia, Italy-based firm's Liaison Plex Yeast Blood Culture Assay is used for the detection of 16 pathogens that are commonly associated with fungal bloodstream infections. Diasorin said that fungal pathogens are a great concern because they can spread with ease between patients in healthcare settings.
The test is the firm's second syndromic panel cleared for use on Diasorin's Liaison Plex instrument, following the Liaison Plex Respiratory Flex Assay. The firm also has been developing Gram-positive and Gram-negative blood culture panels for the diagnosis of bloodstream infections on the Liaison Plex instrument.
"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," Angelo Rago, president of Diasorin's Luminex business, said in a statement. "The Liaison Plex enables clinical labs and healthcare systems throughout the US to meet their diagnostic and antimicrobial stewardship needs for better patient outcomes."
Diasorin CEO Carlo Rosa added that the firm is committed to expanding its multiplex test offerings on the Liaison Plex system.
Diasorin announced in March that it had received clearance for the Liaison Plex platform, which is used for syndromic testing. It incorporates a pricing model that allows users to pay for a portion or all of the results. The instrument allows the use of direct DNA detection or PCR amplification, and it is a replacement for the Verigene sample-to-answer benchtop instrument that Diasorin acquired with its 2021 acquisition of Luminex.