FDA has granted 510(k) clearance and a CLIA waiver for Diasorin’s Liaison Nes multiplex group A strep rapid molecular test, the company said. The assay is submitted on February and is designed to deliver results in about 15 minutes with under one minute of hands-on time. Diasorin said the reagents can be stored at room temperature and the compact, cloud-connected Nes system supports real-time reporting in outpatient and decentralized settings. The group A strep test becomes the second assay cleared on the platform, following FDA clearance and CLIA waiver for the Liaison Nes respiratory panel (flu A, flu B, RSV, and COVID-19) in December. Company guidance tied to Nes indicates it is targeting more than $150 million in US revenue by 2030, positioning the new assay as an additional high-impact infectious-disease use case for the point-of-care menu.
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