Diasorin receives FDA 510(K) clearance for its LIAISON PLEX system

March 5, 2024
LIAISON PLEX is the new multiplexing platform of the group, together with the LIAISON PLEX Respiratory Panel.

Diasorin announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the company’s new LIAISON PLEX platform as well as its first panel of tests, the LIAISON PLEX Respiratory Flex Assay.

Custom panels allow for easier adjustment based on seasonal changes and clinical guidance updates as they occur, helping to avoid costly over-testing. This fully automated, easy to use, sample-to-answer system has a streamlined workflow with room-temperature stable consumables, allowing convenient storage and transportation. The operational hands-on time is only two minutes per sample and results are produced in less than two hours.

The LIAISON PLEX Respiratory Flex Assay tests for 19 pathogens commonly associated with respiratory infections, including 14 viral and 5 bacterial targets detected from nasopharyngeal swabs, further supporting flexibility and fiscal responsibility with a unique approach to panel testing. Flex testing allows users to generate and pay for a subset of specific results based on a patient’s clinical picture.

Diasorin release