Luminex receives FDA EUA for respiratory pathogen panel

March 5, 2021

Luminex Corporation announced that it has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for an expanded version of its NxTAG Respiratory Pathogen Panel (RPP) that includes the SARS-CoV-2 virus for high-throughput respiratory testing, according to a news release from the company.

The new test is a combination of the company's original NxTAG RPP, an FDA-cleared in vitro diagnostic for syndromic respiratory infection testing, and SARS-CoV-2.

The NxTAG RPP + SARS-CoV-2 Assay is expected to detect new variants of the coronavirus, the company said. An in silico analysis of molecular probes used in the assay compared to SARS-CoV-2 sequences available in the GISAID database as of February 11, 2021, determined that key sequences still match and should yield a positive result. The analysis included variants originally detected in the United Kingdom (B.1.1.7), South Africa (B.1.351 or 20H/501Y.V2), Brazil (P.1 lineage or 20J/501Y.V3), and California (one of five reoccurring mutations that constitute the B.1.429 lineage and CAL20C).

NxTAG RPP is a multiplex, high-throughput test designed to enable simultaneous detection of the most common respiratory pathogens for a syndromic testing approach. Following the addition of the SARS-CoV-2 virus target, the panel now includes 19 viral and 2 bacterial targets, combining the most common respiratory pathogens in one panel to help facilitate the rapid identification of various individual and co-occurring infectious pathogens.

A version of the assay, which also detects Legionella pneumophila and the 2009 H1N1 Flu A subtype, also just received a CE Mark, and was commercialized last month in Europe.

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