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Luminex Obtains FDA Emergency Use Authorization for Expanded Respiratory Panel With SARS-CoV-2

NEW YORK ─ Luminex on Thursday announced it has received Emergency Use Authorization from the US Food and Drug Administration for an expanded version of its multiplex NxTag Respiratory Pathogen Panel (RPP) that includes a target for SARS-CoV-2.

NxTag RPP, which runs on the firm's compact Magpix System, is designed for high-throughput testing in high-complexity laboratories and enables simultaneous detection of the most common respiratory pathogens, Luminex said. Following the addition of the SARS-CoV-2 virus target, the panel now includes 19 viral and two bacterial targets, helping to facilitate the rapid identification of individual and co-occurring infectious pathogens, the firm added.

According to Austin, Texas-based Luminex, NxTag RPP provides scalable throughput, allowing clinical labs to run up to 96 samples at a time and generates results in approximately four hours with minimal hands-on time.

The firm said that it expects that its test will detect new coronavirus variants, based on an in silico analysis that compared the molecular probes in its assay with SARS-CoV-2 sequences available in the GISAID database as of Feb. 11. The analysis included variants originally detected in the United Kingdom, South Africa, Brazil, and California, Luminex said.

"Given the emergence of new respiratory pathogens and new variants of these pathogens, it will be increasingly challenging to identify and distinguish the presence and co-existence of SARS-CoV-2, influenza, and other common respiratory pathogens," Nachum Shamir, chairman, president, and CEO of Luminex, said in a statement.

Luminex said that it recently obtained CE marking for a version of its NxTag RPP test that also detects Legionella pneumophila and the 2009 H1N1 Flu A subtype, enabling use of the assay in the European Union and other regions that accept the designation.

In February, Luminex said that the FDA had deprioritized an EUA for its Verigene I standalone SARS-CoV-2 assay but it would move forward with submissions for coronavirus tests already in its plans.

A year ago, Luminex received EUA for the NxTag CoV Extended panel to detect SARS-CoV-2 virus nucleic acids in nasopharyngeal swab specimens.