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DiaSorin S p A : submits the LIAISON NES® Point-of-Care molecular diagnostics system and 4-plex Respiratory Panel to the FDA for 510(k) Clearance and CLIA Waiver
DiaSorin S p A : submits the LIAISON NES® Point-of-Care molecular diagnostics system and 4-plex Respiratory Panel to the FDA for 510(k) Clearance and CLIA
About this update from Diasorin S.p.a.
[{"type":"text","content":"\n \n Diasorin submits the LIAISON NES®Point-of-Care molecular diagnostics system and 4-plex Respiratory Panel to the FDA for 510(k) Clearance and CLIA Waiver\n \n \n \n Diasorin has submitted:\n \n \n 510(k) pre-market notification for the first molecular diagnostic Point-of-Care (POC)\n \n \n platform of the Group, the LIAISON NES®\n 510(K) PRE-MARKET NOTIFICATION FOR A 4-PLEX RESPIRATORY PANEL ON THE PLATFORM\n Clinical Laboratory Improvement Amendments (CLIA) waiver application\n Saluggia, Italy - July 2, 2025 - Diasorin (FTSE MIB: DIA) announces the submission of a 510(k) premarket notification and CLIA waiver application to the U.S. Food and Drug Administration (FDA) for its LIAISON NES®, a next-generation molecular POC testing platform.\n \n \n The submission covers the LIAISON NES®FLU A/B, RSV & COVID-19 panel, designed to simultaneously detect and differentiate four of the most common and clinically significant respiratory pathogens: influenza A, influenza B, SARS-CoV-2, and respiratory syncytial virus (RSV).\n \n \n The LIAISON NES®system is designed to provide laboratory-quality molecular results, delivering high diagnostic accuracy with the speed and simplicity needed at the POC. Its compact footprint, intuitive workflow, and connectivity features make it ideally suited for decentralized settings such as urgent care centers, emergency departments, and physician offices.\n \n \n \"This submission marks a significant milestone in addressing the challenges faced by healthcare systems,\" said Angelo Rago, President of Luminex. \"The LIAISON NES®system empo\n \n ers clinicians ith rapid, reliable results that support a test-and-treat approach, enabling timely, informed decisions\n that improve patient care and help curb the spread of respiratory infections.\"\n \n \n This development reinforces Diasorin's strategy to deliver a comprehensive molecular diagnostics ecosystem that enables effective Diagnostic Stewardship, providing the diagnostics tools to offer the right tests, for the right patient, at the right time, ultimately leading to more accurate diagnoses, better patient outcomes, and more efficient use of healthcare resources1. The company's molecular offering ranges from targeted solutions on the LIAISON®MDX, featuring several De Novo FDA-authorized specialty assays, to multiplex capabilities on the LIAISON PL...