we receive e we publish the following press release issued by Diasorin.
Diasorin (FTSE MIB: DIA) announces that it has received the510(k) clearance by the US Food and Drug Administration (FDA) for NxTAG® Respiratory Pathogen Panel (RPP) v2. This updated panel adds to Diasorin's expanding molecular multiplexing portfolio, improving the usability of the assay. Diasorin partnered with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the US Department of Health and Human Services, to support the development and clearance of this syndromic panel.
What is NxTAG® RPP v2
NxTAG® RPP v2 includes numerous pathogens commonly associated with respiratory infections and adds SARS-CoV-2 to its mix of 19 viral and 2 bacterial targets. Furthermore, the new kit addresses the needs of Diasorin customers on non-automated multiplexing molecular platforms. Indeed, the updated panel offers higher performance by increasing inclusiveness and specificity while improving the usability of the product, thanks to the easy identification of plate seals. These updates confirm the test as the first choice for high-throughput laboratories, allowing you to identify up to 96 samples in a single analysis, thanks to freeze-dried, ready-to-use reagent wells.
This NxTAG® solution on MAGPIX® systems alongside the Flex respiratory panel on the recently authorized LIAISON PLEX® analyzer: the two syndromic solutions respond respectively to the need to perform high-throughput analyzes and to allow panel customization, providing laboratories with a complete range of solutions for multiplexing molecular diagnostics.
“Following the completion of the Luminex integration, we are now focused on further advancing our solutions. This implies both constant updating aligned with evolving customer needs and continuous innovation and development of new products and platforms,” he commented Angel Rago, President of luminex. “Our NxTAG solution remains a key component of Diasorin's syndromic molecular portfolio, offering laboratories a robust high-throughput analysis solution with proven and reliable performance.”
This project was funded in whole or in part with federal funds of the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority under contract number 75A50120P00108.
Information about Diasorin
Diasorin, an Italian multinational company listed on the FTSE MIB index, is a global leader in the field of In Vitro Diagnostics (IVD) and since 2021 has also been active internationally in the Life Science sector. For over 50 years, the Company has developed, manufactured and marketed reagent kits used by diagnostic laboratories around the world.
The Group is present on 5 continents with 35 companies, 4 branches, 10 production sites and 9 research centers. The wide range of diagnostic tests and Life Science solutions, made available through continuous investments in research, positions Diasorin as the player with the widest range of specialty solutions available in the sector and identifies the Group as the "Diagnostics Specialist".
