LMNX - Luminex wins FDA emergency use nod for expanded NxTAG Respiratory Panel Test

Luminex (LMNX) has received Emergency Use Authorization ((EUA)) from the FDA 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 panel now includes 19 viral and 2 bacterial targets.The new test is a combination of company's original NxTAG RPP, an FDA-cleared in vitro diagnostic for syndromic respiratory infection testing, and SARS-CoV-2. NxTAG RPP allows clinical labs to run up to 96 samples at a time - generating results in approx. 4 hours. Importantly, the NxTAG RPP + SARS-CoV-2 Assay is expected to detect new variants of the coronavirus. 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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Luminex wins FDA emergency use nod for expanded NxTAG Respiratory Panel Test