The FDA issued 510(k) clearance and a CLIA waiver for Diasorin’s LIAISON Nes four‑plex molecular assay for Flu A/B, RSV and SARS‑CoV‑2, enabling laboratory‑quality PCR testing at the point of care. Diasorin said the Liaison Nes platform, developed with a major U.S. pharmacy chain, runs a three‑step workflow and returns results in about 15 minutes, positioning the company in rapid molecular POC testing. Diasorin CEO Carlo Rosa framed the clearance as the company’s entry into molecular POC and said additional infectious‑disease assays are planned for the platform. The clearance lowers barriers for retail and clinic deployment of multiplexed respiratory testing, potentially changing seasonal testing volumes and channel strategies for IVD firms. Regulators and buyers will watch real‑world throughput, reimbursement and integration with pharmacy workflows; the decision may force competitors to accelerate POC PCR roadmaps.
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