FDA Clears, CLIA-Waives Diasorin Flu A/B, RSV, SARS-CoV-2 Molecular Assay

Original from: genomeweb

Italian in vitro diagnostics firm Diasorin said on Sunday that the US Food and Drug Administration has issued 510(k) clearance and CLIA-waived the firm's first assay for use on the Liaison Nes platform.

The four-plex assay is for the detection and differentiation of Flu A/B, respiratory syncytial virus, and SARS-CoV-2, the virus that causes COVID-19. The Liaison Nes is a next-generation point-of-care testing platform that leverages PCR technology and is designed to bring laboratory-quality testing close to the patient without the need for specialized laboratory personnel, Saluggia-based Diasorin said. The platform, developed in collaboration with a "leading" US pharmacy chain, has a three-step workflow and achieves test results in 15 minutes. 

"Introducing LIAISON Nes is not just about adding a next-generation molecular platform to our portfolio, but it marks Diasorin’s entry into the molecular POC market, expanding our ability to deliver rapid, high-quality diagnostics closer to patients," Diasorin CEO Carlo Rosa said in a statement. "With LIAISON Nes, we are redefining accessibility to molecular diagnostics and marking a pivotal moment in Diasorin’s growth strategy."

Additional assays for infectious diseases are also planned for the Liaison NES, the company said.

Source: FDA Clears, CLIA-Waives Diasorin Flu A/B, RSV, SARS-CoV-2 Molecular Assay