The FDA issued a 510(k) clearance and a CLIA waiver for Diasorin’s four‑plex molecular assay on the Liaison Nes platform, enabling rapid differentiation of Flu A/B, RSV and SARS‑CoV‑2 at the point of care. Diasorin said the Liaison Nes, developed with a major U.S. pharmacy chain partner, delivers lab‑quality PCR results in about 15 minutes and uses a three‑step workflow. CEO Carlo Rosa framed the approval as Diasorin’s formal entry into the molecular POC market and said additional infectious‑disease assays are planned for the platform. A CLIA waiver allows non‑laboratory personnel to run the test in near‑patient settings, expanding testing capacity outside traditional labs. The clearance shifts competitive dynamics in the molecular diagnostics market by combining multiplex detection with rapid turnaround and pharmacy‑level deployment.
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