Molecular Diagnostics System Provides Lab-Quality Results at POC

Currently, there is a need for a comprehensive molecular diagnostics ecosystem that enables effective diagnostic stewardship, providing the diagnostic 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 resources. Now, a point-of-care molecular diagnostics system aims to address the challenges faced by healthcare systems by empowering clinicians with rapid, reliable results that support a test-and-treat approach, enabling timely, informed decisions.

DiaSorin SpA (Saluggia, Italy) has submitted 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. 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).

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.

The LIAISON NES system minimizes operational, administrative, and supply chain concerns that historically have prevented adoption of POC diagnostics at many near-patient locations. The system aims to overcome these barriers by creating a solution that is rapid and easy to perform, alleviates supply chain constraints by providing a long shelf life at room temperature with automatic reordering for an uninterrupted supply of tests. 

In addition to the LIAISON NES system, 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 PLEX, the first fully customizable syndromic molecular platform on the market, and the MAGPIX platform for high-throughput syndromic testing. This integrated portfolio supports a broad spectrum of diagnostic needs, from centralized lab testing to rapid, near-patient diagnostics.

"The future of diagnostic testing lies in addressing real world challenges," said Carlo Rosa, CEO of Diasorin. "As leaders in diagnostics, we remain steadfast in our commitment to innovation, delivering solutions that empower healthcare systems to maintain and elevate patient care, even amid cost pressures and resource constraints. The LIAISON NES submission to the FDA aligns with the strategic priorities outlined at our 2023 Investor Day and marks another significant milestone in our path to enter the near-patient molecular diagnostics space, matching emerging medical needs."

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