Molecular Multiplexing Panel for Blood Culture Identification Enables Targeted Treatment Decisions

Each year, approximately 250,000 patients in the US are diagnosed with bloodstream infections (BSIs). Sepsis resulting from BSIs has an average mortality rate of 16-40%, and any delays in initiating appropriate treatment increase patient risk. Sepsis is also the most expensive cause of hospitalization in the US, accounting for more than USD 20 billion annually. Gram-negative bacteremia represents about 30% of all positive blood cultures, and each pathogen along with its resistance genes often necessitates adjustments to the initial empiric therapy. Now, a multiplex blood culture panel can improve the microbiological diagnosis of BSIs by detecting Gram-negative bacteria and relevant resistance genes, thereby enhancing standard-of-care workflows and reducing operational costs.

Diasorin’s (Saluggia VC, Italy) LIAISON PLEX Gram-Negative Blood Culture Assay enables clinicians to make more targeted treatment decisions within two hours after the Gram stain by quickly identifying pathogens and detecting resistance determinants. The assay utilizes Diasorin’s proprietary NanoGrid technology, a unique non-amplified molecular chemistry designed to reduce false positives. Because this panel is based on Gram stain results and focuses exclusively on Gram-negative pathogens, it enhances diagnostic stewardship and helps control treatment costs compared to current market solutions that include a broader range of pathogens associated with bacteremia, regardless of Gram stain results.

Diasorin has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the LIAISON PLEX Gram-Negative Blood Culture Assay, which is the second of three molecular multiplex panels for blood culture identification on the LIAISON PLEX instrument. Previously, Diasorin received FDA clearance for the LIAISON PLEX Respiratory Flex Assay in March 2024 and the LIAISON PLEX Yeast Blood Culture Assay in June 2024.

“We firmly believe that LIAISON PLEX provides unique flexibility by enabling clinicians to select the most appropriate blood panel for their patients. This ensures that clinical laboratories can generate reliable results more quickly and cost-effectively,” said Angelo Rago, President of Luminex. “We are committed to developing critically important tests for the platform to expand its application to a broader range of healthcare needs.”

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