Original from: DiaSorin
Diasorin (FTSE MIB: DIA) announced today 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.
Group A Streptococcus is a leading cause of acute pharyngitis and accounts for millions of healthcare visits each year. Because symptoms of bacterial and viral infections often overlap, accurate and timely identification is critical to support appropriate patient management. Traditional methods may require centralized testing or rely on less sensitive rapid antigen tests, which can delay treatment decisions or require confirmatory testing.
The LIAISON NES addresses these challenges by combining molecular-level accuracy with the speed and simplicity required in decentralized settings, enabling healthcare providers to deliver reliable results during the initial patient visit. 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, ensuring reliable POC detection;
• 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.
“The addition of Group A Strep reflects our commitment to expanding the LIAISON NES menu to address high-impact infectious diseases,” said Angelo Rago, President of Luminex. “We continue to build a robust pipeline that enhances the clinical value of near-patient molecular testing while reinforcing our leadership in diagnostics.”
Source: DiaSorin Announces FDA 510(k) Clearance and CLIA Waiver for the LIAISON NES Group A Streptococcus (GAS) Assay
