FDA Issues EUA for Respiratory Infection Testing, SARS-CoV-2

Luminex announced yesterday the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for a new expanded version of its NxTAG Respiratory Pathogen Panel (RPP) that includes the SARS-CoV-2 virus for high-throughput respiratory testing.

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

NxTAG RPP detects common respiratory pathogens for syndromic testing. 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.

“Clinical laboratories using the assay will be able to scale-up their testing for both COVID-19 and the flu with one high-capacity diagnostic platform that can provide much-needed information for appropriate patient treatment,” Chairman, President, and CEO of LuminexNachum "Homi" Shamir, said. “This is especially important given that the symptoms for the flu, COVID-19, and other respiratory illnesses can be very similar, but their treatment may be very different.

This test is expected to detect new variants of the coronavirus. An in-silico analysis of molecular probes used in the assay compared to SARS-CoV-2 sequences available in the GISAID database determined that key sequences still match and should yield a positive result.

Last summer, the FDA issued an EUA for Luminex’s xMAP SARS-CoV-2 Multi-Antigen IgG Assay.

Luminex is based in Austin, Texas and the company is involved in clinical diagnostics, pharmaceutical drug discovery, biomedical research, genomic and proteomic research, biodefense research, and food safety.