NEW YORK – Sorin said Wednesday it has received U.S. Food and Drug Administration 510(k) approval for a molecular test for a common cause of fungemia.
The Liaison Plex Fungal Blood Culture Assay (Liaison Plex Blood Culture Assay) from Saluggia, Italy, is used to detect 16 pathogens commonly associated with fungal bloodstream infections. Fungal pathogens are a great concern because they can be easily transmitted from patient to patient in a healthcare facility, Solin said.
The test is the company’s second syndromic test to be used on Diasorin’s Liaison Plex instrument, following the Liaison Plex Breath Flex assay. The company has also been developing Gram-positive and Gram-negative blood culture Panels for use with the Liaison Plex instrument for diagnosing bloodstream infections.
Angelo Rago, president of Diasorin’s Luminex business, said in a statement, “The Liaison Complex Yeast Blood Culture Trial adds to our already market-leading portfolio of bloodstream infections, providing a rapid solution for this serious disease state.” Liaison Plex enables clinical laboratories and healthcare systems across the U.S. to meet their diagnostic and antimicrobial management needs for better patient outcomes.”
Sorin CEO Carlo Rosa added that the company is committed to expanding its multiple testing services on the Liaison Plex system.
Diasorin announced in March that it had licensed the Liaison Plex platform for syndromic testing. It incorporates a pricing model that allows users to pay for some or all results. The instrument allows the use of direct DNA detection or PCR amplification, and it is a replacement for the Verigene Sample Answer Benchtop Instrument, which Diasorin acquired when it acquired Luminex in 2021.
