DiaSorin S p A : receives FDA 510(k) clearance for the updated syndromic panel NxTAG® Respiratory Pathogen Panel v2

DIASORIN RECEIVES FDA 510(K) CLEARANCE FOR THE UPDATED SYNDROMIC PANEL NXTAG® RESPIRATORY PATHOGEN PANEL V2

• NXTAG® RESPIRATORY PATHOGEN PANEL (RPP) V2 IS A MOLECULAR MULTIPLEX PANEL THAT DETECTS 21 DIFFERENT PATHOGENS (BACTERIA, VIRUSES)
• THE RPP V2 PANEL IS NOW AVAILABLE IN THE U.S. ON THE MAGPIX® SYSTEM
• THE NEW UPDATED PANEL ADDS TO DIASORIN'S MOLECULAR MULTIPLEXING PORTFOLIO OFFERING A FULL RANGE OF SOLUTIONS ON BOTH NON-AUTOMATED AND FULLY AUTOMATED PLATFORMS

Saluggia, Italy - May 16, 2024 - Diasorin (FTSE MIB: DIA) announces 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 expanding 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. Furthermore, listening closely to the needs of the Diasorin customer base on the existing molecular multiplexing non-automated platforms, this updated kit provides enhanced target performance to increase inclusivity and specificity, while improving usability of the product with easier-to-identify plate seals. These product updates seamlessly integrate with existing features, solidifying this test as a first-choice for high throughput laboratories, allowing 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: the two syndromic solutions respectively address the need for high- throughput batch testing and on-demand random access, representing a unique comprehensive solution for laboratories.

"As the result of the successful completion of the Luminex integration, we are now progressing to advance our solutions forward. This involves incorporating updates aligned with the evolving needs of our customers, as well as delivering innovation through the development of new products and platforms", said Angelo Rago, President of Luminex. "Our signature NxTAG remains a cornerstone to the Diasorin syndromic molecular portfolio, offering laboratories a solid high-throughput testing solution with proven and trusted performance."

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.