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DiaSorin Submits Multiplex Yeast Assay for FDA Clearance

NEW YORK – DiaSorin on Wednesday said it has submitted its molecular panel for the identification of fungemia for US Food and Drug Administration 510(k) clearance.

The Liaison Plex Yeast Blood Culture Assay is a multiplex test that is used for the detection of fungi or yeasts, such as Candida auris, in a blood sample.

"This new blood culture panel will allow clinical laboratories and physicians to better address emerging clinical diagnostic needs, further strengthening our position in syndromic molecular testing," Angelo Rago, president of DiaSorin's Luminex business, said in a statement.

The Saluggia, Italy-based firm said the assay is the first of three panels that will be used to aid the diagnosis of bloodstream infections on the Liaison Plex instrument. DiaSorin is also developing Gram-positive and Gram-negative blood culture panels for clearances. The Liaison Plex instrument received FDA 510(k) clearance earlier this month along with a syndromic panel for the identification of respiratory disease.

The Liaison Plex, which is the successor to DiaSorin's Verigene I system, originally developed by Luminex, leverages nanoparticle chemistry technologies for direct DNA detection or PCR amplification.