The point-of-care assay provides results in 15 minutes and received a waiver for use in decentralized settings.
DiaSorin has received US Food and Drug Administration (FDA) 510(k) clearance and a Clinical Laboratory Improvement Amendments waiver for its Group A Streptococcus assay. The test is designed for use on the LIAISON NES point-of-care molecular diagnostics platform.
The clearance follows the FDA authorization of the platform’s respiratory panel for influenza A and B, respiratory syncytial virus, and COVID-19 in December 2025. Group A Streptococcus is a primary bacterial cause of acute pharyngitis and leads to millions of healthcare visits annually. Because symptoms of bacterial and viral infections often overlap, the company says accurate identification is necessary to support patient management.
Point-of-Care Molecular Accuracy
The assay provides molecular-level results at the point of care in approximately 15 minutes. By utilizing polymerase chain reaction technology, the system offers high sensitivity and specificity, allowing for clinical decisions without the requirement for confirmatory culture.
The system features a workflow with less than one minute of hands-on time and uses reagents stored at room temperature. The compact, cloud-connected platform is designed for use in outpatient and decentralized settings to support real-time reporting.
“The addition of Group A Strep reflects our commitment to expanding the LIAISON NES menu to address high-impact infectious diseases,” says Angelo Rago, president of Luminex, in a release. “We continue to build a robust pipeline that enhances the clinical value of near-patient molecular testing while reinforcing our leadership in diagnostics.”
By providing results during a single visit, the test aims to support clinical decision-making, reduce the need for follow-up appointments, and help minimize inappropriate antibiotic use, according to the press release.
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