NEW YORK – Diasorin said Friday that it has received US Food and Drug Administration 510(k) clearance for a molecular panel to diagnose Gram-negative bloodstream infections.
The Saluggia, Italy-based firm said that its Liaison Plex Gram-Negative Blood Culture Assay is used for the identification of 19 Gram-negative bacteria and eight resistance genes, with results returned about two hours after a Gram stain. The test is designed for use on the company's Liaison Plex syndromic testing instrument, which uses nanoparticle chemistry technologies, cartridge-based tests, and the option to run full molecular panels or pay a reduce price to see only some of the results.
Diasorin said that Gram-negative bacteria are a common cause of sepsis, and they are more likely to be resistant to antibiotics than Gram-positive bacteria.
The assay is the second of three multiplex bloodstream infection panels that Diasorin has designed for the Liaison Plex testing system, which received FDA clearance in March 2024. The firm received 510(k) clearance in June for its Liaison Plex Yeast Blood Culture Assay that is used for the detection of 16 pathogens that are commonly associated with fungal bloodstream infections, and it announced in November that it had submitted for clearance a panel for the identification of Gram-positive pathogens in blood.
The firm also offers on the Liaison Plex a syndromic respiratory infection panel that was cleared along with the instrument.