State-Of-The-Art POC Molecular System to Allow Untrained Operators to Perform Testing for Viral and Bacterial Pathogens

DiaSorin (Saluggia, Italy) has announced that DiaSorin Molecular LLC will collaborate with the Biomedical Advanced Research and Development Authority (BARDA), to support the FDA 510(k) clearance of a CLIA-waived molecular solution for infectious disease testing. DiaSorin will develop, verify, and clinically validate an FDA- cleared and CLIA-waived point-of-care (POC) instrument, known as the LIAISON NES, along with an initial combination test for SARS-CoV-2 and influenza A & B.

The LIAISON NES is designed to allow untrained operators to perform testing for viral and bacterial pathogens using state-of-the-art molecular technology with the intent to support the decentralization of diagnostic testing beyond the hospital setting. Patients will benefit from expanded access to rapid, high-quality diagnostic results at a reduced cost. Furthermore, this diagnostic capability will be important to help combat the spread of new and emerging pathogens. Future product development will focus on additional respiratory infections and sexually transmitted diseases, among others.

Image: DiaSorin will develop, verify, and clinically validate the FDA- cleared and CLIA-waived LIAISON NES POC analyzer (Photo courtesy of DiaSorin)

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 (approximately 15 minutes) 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. The LIAISON NES system will be fully cloud integrated to automate many tasks required to fully implement POC testing and securely share data in medical as well as other distributed settings.

"The project is progressing at full speed as a corporate priority to position DiaSorin in decentralized diagnostics - a new and strategic market segment for the company," said Angelo Rago, President of Luminex and DiaSorin Molecular LLC. "We are honored to continue our productive collaborations with BARDA to improve access to critical infectious disease tests with the LIAISON NES system."

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