June 2025—Diasorin announced it has received FDA 510(k) clearance for the Liaison Plex Gram-negative blood culture assay, the second of the company’s three multiplex molecular panels for blood culture pathogen identification on the Liaison Plex. The assay is designed to identify 27 targets—19 Gram-negative bacteria and eight relevant resistance gene targets, including Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Pseudomonas aeruginosa, Acinetobacter species, Citrobacter species, Enterobacter species, and Proteus species. Results are available about two hours after a Gram stain.
The Liaison Plex blood culture portfolio consists of the yeast, Gram-negative, and Gram-positive blood culture assays.
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