Diasorin’s CLIA‑Waived NES Launch Signals a New Phase in Molecular POC — What It Means for the Market

Published on 2026-01-24 15:39:12 by giendi

Diasorin just secured FDA 510(k) clearance and CLIA waiver for its first assay on the Liaison NES, a next‑generation molecular point‑of‑care platform capable of delivering PCR‑quality results in 15 minutes. The cleared 4‑plex panel (Flu A/B, RSV, SARS‑CoV‑2) positions NES directly in the high‑growth respiratory POC segment and marks Diasorin’s most significant U.S. decentralized‑testing move to date. What makes this notable: True molecular performance at the point of care — a direct challenge to incumbents like Abbott ID NOW, Roche Liat, Cepheid Xpress, and BD. Designed for retail and urgent‑care workflows, co‑developed with a major U.S. pharmacy chain. * Three‑step workflow, dry swabs, room‑temperature consumables — clear focus on operational simplicity. * CLIA waiver unlocks immediate access to pharmacies, clinics, and decentralized care settings. This is more than a product launch — it’s a strategic entry into a multi‑billion‑dollar molecular POC market that continues to expand as respiratory seasonality, consumer expectations, and decentralized care models reshape diagnostic demand. For a deeper, data‑driven view of the POC landscape… The new GRN IVD Consulting Point‑of‑Care Market Report breaks down the forces shaping this space, including: * Market sizing and growth trajectories across respiratory, cardiac, and infectious disease POC * Competitive intelligence on platforms like NES, ID NOW, Liat, GeneXpert Xpress, and more * Technology, workflow, and menu trends driving adoption in pharmacies and urgent care * Strategic insights for investors, business development teams, and diagnostic manufacturers. If you’re tracking where POC is heading, who’s positioned to win, and how new entrants like Diasorin NES will reshape the competitive field, this report gives you the clarity and strategic depth you need. For a copy of the report, register and login.