Point-of-Care Molecular Test Detects Group A Strep in Minutes

Group A Streptococcus is a leading bacterial cause of acute pharyngitis and a common reason for outpatient visits, accounting for millions of healthcare encounters each year. Because symptoms of bacterial and viral infections often overlap, accurate and timely identification is critical to guide appropriate patient management. Traditional approaches may require centralized testing or rely on less sensitive rapid antigen tests, delaying decisions or necessitating confirmatory culture. A newly launched test now delivers definitive molecular results at the point of care in approximately 15 minutes.

Diasorin has received 510(k) clearance and a Clinical Laboratory Improvement Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA) for the LIAISON NES Group A Streptococcus (GAS) assay on the LIAISON NES point-of-care (POC) molecular diagnostics platform. The authorization, announced June 19, 2026, follows FDA clearance of the LIAISON NES FLU A/B, RSV & COVID-19 assay in December 2025, expanding the platform’s menu and clinical utility. The GAS test is intended to deliver definitive results during the initial patient visit across decentralized settings.

The assay uses polymerase chain reaction (PCR) to provide molecular-level accuracy for detection of Group A Streptococcus at the point of care. The system reports positive results as soon as target amplification is detected and provides definitive negative results in approximately 15 minutes, eliminating the need for confirmatory culture. The workflow mirrors the previously cleared LIAISON NES respiratory panel, with under one-minute hands-on time and room-temperature reagents to streamline operation.

The compact, cloud-connected instrument supports real-time reporting for outpatient and other decentralized sites. By enabling accurate diagnosis in a single visit, the test supports timely clinical decision-making and reduces the need for follow-up visits. The assay offers high sensitivity and specificity with PCR 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. We continue to build a robust pipeline that enhances the clinical value of near-patient molecular testing while reinforcing our leadership in diagnostics,” said Angelo Rago, President of Luminex.