NEW YORK – Diasorin said on Monday that it has submitted a molecular panel to diagnose Gram-positive bloodstream infections to the US Food and Drug Administration for 510(k) marketing clearance.
The Saluggia, Italy-based firm's Liaison Plex Gram-Positive Blood Culture Assay is a syndromic test for the detection of Gram-positive bacterial pathogens in blood, with results in about two hours. The test is performed with the firm's NanoGrid technology for the direct detection of nucleic acids without amplification and is designed to run on the firm's Liaison Plex instrument.
Diasorin said the test is its third and final blood culture panel for bloodstream infections to run on the Liaison Plex analyzer, following the 510(k) clearance in June of the Liaison Plex Yeast Blood Culture Assay and submission in September for clearance of the Liaison Plex Gram-Negative Blood Culture Assay.
Diasorin also received 510(k) clearance in March for the Liaison Plex instrument and Liaison Plex Respiratory Flex Assay for the detection of viral and bacterial targets in nasopharyngeal swab samples. The instrument is used for DNA detection with or without PCR amplification.