Diasorin announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the company’s NxTAG Respiratory Pathogen Panel (RPP) v2.
This updated panel, an addition to Diasorin’s molecular multiplexing portfolio, responds to customer needs by enhancing test usability. Diasorin collaborated with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, to support the development and clearance of this updated syndromic panel.
NxTAG RPP v2 covers many pathogens commonly associated with respiratory infections, and now adds SARS-CoV-2 to its mix of 19 viral and 2 bacterial targets. These product updates integrate with existing features and allow for testing of up to 96 specimens in a single run with its ready-to-use lyophilized reagent wells.
This NxTAG solution on MAGPIX systems complements the recently cleared LIAISON PLEX Respiratory Flex panel.
This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50120P00108.
