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Diasorin Nabs FDA 510(k) Clearance for Expanded Respiratory Panel

NEW YORK – Diasorin said Thursday that the US Food and Drug Administration has granted 510(k) marketing clearance for an updated molecular respiratory panel that adds detection of the SARS-CoV-2 virus.

The Saluggia, Italy-based firm's NxTag Respiratory Pathogen Panel v2 is a multiplex PCR assay that is used for the qualitative detection of 19 viral and two bacterial targets in nasopharyngeal swab samples from patients with signs and symptoms of respiratory tract infection. The test is designed for use in the company's high-throughput Luminex Magpix instrument which has a capacity of 96 specimens per run and ready-to-use lyophilized reagent wells.

The firm said that the NxTag RPP v2 test also includes updates for improved test accuracy and ease of use with easier-to-identify plate seals compared to the previous version of the test.

In addition to the SARS-CoV-2 virus, the panel is used to identify infections with pathogens including other coronaviruses, flu A/B, respiratory syncytial virus, Chlamydia pneumoniae, and Mycoplasma pneumoniae, among other targets.

The firm noted that it received funding from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) to develop the expanded NxTag panel. Prior to its acquisition by Diasorin, Luminex had announced in September 2020 that BARDA had awarded the company about $5.4 million to develop an expanded NxTag RPP assay to include SARS-CoV-2 and allow high-throughput COVID-19 testing.