Summary:
Diasorin has received FDA 510(k) clearance for its LIAISON PLEX Gram-Positive Blood Culture Assay, completing its syndromic blood culture portfolio for rapid and targeted bloodstream infection diagnosis.

Key Takeaways:

  1. Complete Portfolio: Diasorin now has FDA clearance for both respiratory and blood culture panels on the LIAISON PLEX platform.
  2. Rapid & Targeted Results: The assay identifies 17 targets in under 2 hours, enhancing diagnostic precision and reducing unnecessary broad testing.
  3. Advanced Technology: NanoGrid technology enables accurate nucleic acid detection without conventional amplification, lowering false positive risk.

Diasorin has announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the LIAISON PLEX Gram-Positive Blood Culture Assay, the final1 syndromic blood culture panel for the microbiological diagnosis of bloodstream infections on the solution.

Diasorin has now received 510(k) clearance from the FDA for both the respiratory2 and the blood culture portfolio on the LIAISON PLEX.

The selection of the test panel for diagnosing bloodstream infections takes place as the next step following culture and Gram staining, which are performed by laboratories in cases of suspected bloodstream infection. Based on the Gram stain result, the laboratory can rapidly identify the type of pathogen responsible (yeasts, gram-positive, or gram-negative bacteria) and select the most appropriate and specific molecular panel. This targeted approach helps reduce costs compared to currently available solutions, which instead test for a wide range of pathogens regardless of the Gram stain outcome.

LIAISON PLEX Gram-Positive Blood Culture Assay Detects 17 Targets

The LIAISON PLEX Gram-Positive Blood Culture Assay detects 17 targets (13 gram-positive bacteria and 4 relevant resistance gene targets) in under 2 hours, including Bacillus spp. and mecC, in addition to the targets currently found on the VERIGENE Gram-Positive Blood Culture Test, providing clinicians with the ability to make rapid and targeted treatment decisions.

Features Proprietary NanoGrid Technology

The assay features Diasorin’s proprietary NanoGrid technology, which allows the detection of nucleic acids without the need for conventional amplification reactions, thereby minimizing the risk of false positives.

“With this FDA clearance, we are now positioned to offer our expanding customer base a comprehensive and flexible menu of multiplex panels for the diagnosis of bloodstream infections on the LIAISON PLEX” says Angelo Rago, president of Luminex. “This milestone provides clinicians with unmatched flexibility to tailor blood culture panels based on individual patient needs. We are committed to continue expanding our offering on the platform to ensure broad access to our multiplexing solutions that deliver fast, accurate, and cost-effective results, ultimately supporting improved patient outcomes.”

Featured Image: The LIAISON PLEX Gram-Positive Blood Culture Assay, the final syndromic blood culture panel for the microbiological diagnosis of bloodstream infections on the solution, has received 510(k) clearance from the FDA. Image: Diasorin

References

1 The LIAISON PLEX Blood Culture portfolio consists of 3 panels: LIAISON PLEX Yeast Blood Culture Assay; LIAISON PLEX Gram-Negative Blood Culture Assay; LIAISON PLEX® Gram-Positive Blood Culture Assay

2 LIAISON PLEX Respiratory Flex Assay