Diasorin announced that it has received 510(k) clearance and CLIA waiver from the U.S. Food and Drug Administration (FDA) for its Group A Streptococcus (GAS) assay, to be used on the LIAISON NES Point-of-Care (POC) molecular diagnostics platform.
This milestone follows the FDA clearance of the LIAISON NES FLU A/B, RSV & COVID-19 assay in December 2025, further expanding the platform’s menu and clinical utility.
Key benefits of the system include:
• Rapid results: Provides actionable results as soon as a positive target is amplified, with definitive negative results in approximately 15 minutes, enabling earlier clinical decisions without requiring confirmatory culture.
• High sensitivity and specificity: provides molecular-level accuracy with PCR.
• Simple workflow: utilizes the identical easy workflow of the previously cleared LIAISON NES FLU A/B, RSV & COVID-19 assay with under one-minute hands-on time and room temperature reagents, optimizing ease-of-use.
• Point-of-Care ready: compact, cloud-connected system supports real-time reporting for outpatient and decentralized settings.
By enabling accurate diagnosis in a single visit, the LIAISON NES Group A Strep test supports timely clinical decision-making, reduces the need for follow-up visits, and helps minimize inappropriate antibiotic use.
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