Diasorin secured FDA 510(k) clearance and a CLIA waiver for its four‑plex PCR assay on the Liaison Nes point‑of‑care platform, the company announced. The test detects and differentiates influenza A/B, respiratory syncytial virus (RSV), and SARS‑CoV‑2 with a workflow designed to deliver laboratory‑quality results in roughly 15 minutes. Diasorin said the Liaison Nes launch marks its entry into the molecular POC market and that additional assays for infectious diseases are planned. The platform was developed in collaboration with a major U.S. pharmacy chain to expand near‑patient testing in retail and outpatient settings. A CLIA waiver allows use outside traditional labs and could speed adoption in community clinics and pharmacies, shifting respiratory testing volumes away from centralized labs. The rapid, multiplex capability is likely to attract health systems seeking cost‑effective triage during respiratory seasons. Diasorin framed the platform as strategic for growth in decentralized diagnostics; payors and providers will monitor performance, throughput, and reimbursement dynamics as deployment scales.
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