Diasorin won FDA 510(k) clearance and a CLIA waiver for a multiplex group A streptococcus rapid molecular test on its Liaison Nes point-of-care PCR instrument. The company said the test delivers results in about 15 minutes with under one minute of hands-on time. Diasorin also said reagents can be stored at room temperature and that the Nes system is compact and cloud connected for real-time reporting in outpatient and decentralized settings. The group A strep test becomes the second assay on the Nes platform after FDA clearance and CLIA waiver for a respiratory panel targeting influenza A, influenza B, RSV, and COVID-19 in December. Diasorin previously described plans for Nes to reach more than $150 million in US revenue by 2030, positioning further panel expansion as part of its medium-term growth strategy. Clinically, rapid molecular confirmation of group A strep is a high-volume use case in acute pharyngitis and can affect antibiotic prescribing decisions in ambulatory workflows.
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