Diasorin said FDA has granted 510(k) clearance and a CLIA waiver for its Liaison Nes Group A Strep rapid molecular test. The assay targets acute pharyngitis, delivering results in about 15 minutes with under one minute of hands-on time, using room-temperature-stable reagents. The company positioned the clearance as the second assay on the Liaison Nes point-of-care PCR instrument, after the December FDA clearance and CLIA waiver for the Liaison Nes respiratory panel covering influenza A, influenza B, RSV and COVID-19. Diasorin’s executives previously outlined an ambition for the Nes platform to reach more than $150 million in US revenue by 2030, and the firm noted its expansion plans include additional assays across high-impact infectious diseases.
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