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www.fdanews.com/articles/201687-luminex-receives-eua-for-expanded-respiratory-pathogen-panel-clearing-it-for-covid-19
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Luminex Receives EUA for Expanded Respiratory Pathogen Panel, Clearing It for COVID-19

March 5, 2021

Luminex has been given Emergency Use Authorization (EUA) from the FDA for an expanded version of its NxTAG Respiratory Pathogen Panel, authorizing its use in testing for COVID-19 infection.

The multiplex, high-throughput test is designed to simultaneously detect the most common respiratory pathogens. The new version of the test includes 19 viral and two bacterial targets, including SARS-CoV-2. Significantly, the company said the test is expected to detect new coronavirus variants, including the UK, South African and Brazilian strains, as well as a variant first found in California.

The test allows clinical labs to run up to 96 samples at a time, producing results in approximately four hours. It runs on Luminex’s MAGPIX system and is designed to be used in high-complexity molecular laboratories.

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