NEW YORK – Diasorin said Friday that it has submitted a blood-based molecular panel for Gram-negative pathogens and drug resistance genes to the US Food and Drug Administration for 510(k) clearance.
The firm's Liaison Plex Gram-Negative Blood Culture Assay is used for the simultaneous detection in blood of bacterial pathogens and genes that are connected with antimicrobial resistance, with results in less than two hours after a Gram stain. The firm said that selecting a panel based on the results of a Gram stain can help to reduce healthcare costs.
The test is designed for use on Diasorin's fully automated Liaison Plex platform for syndromic molecular testing. The company said that the test incorporates its NanoGrid non-amplified molecular chemistry to minimize false positive results.
In March, Saluggia, Italy-based Diasorin received FDA 510(k) clearance for its Liaison Plex Respiratory Flex Assay for the detection of viral and bacterial targets in nasopharyngeal swab samples and its Liaison Plex instrument, which allows labs to use direct DNA detection or PCR amplification. It also received 510(k) clearance in June for its Liaison Plex Yeast Blood Culture Assay for the detection of common causes of fungemia.
The company noted that Gram-negative bacteria are associated with about 30 percent of positive blood cultures, and they are more often resistant to antibiotics than Gram-positive bacteria.