Luminex receives FDA Emergency Use Authorization for NxTAG CoV Extended Panel to detect SARS-CoV-2 Virus

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On Mar. 27, 2020, Luminex announced the U.S. Food and Drug Administration (FDA) had issued an Emergency Use Authorization (EUA) for its NxTAG CoV Extended Panel. The intended use of this multiplex test is the detection of the SARS-CoV-2 virus.

High complexity molecular laboratories can now use the NxTAG test on Luminex’s easy-to-use, compact MAGPIX System to rapidly detect the virus that causes COVID-19 disease for up to 96 patients in approximately 4 hours.

Luminex responded to the coronavirus outbreak by developing the NxTAG CoV Extended Panel as a high-throughput, scalable, cost-effective option for detecting SARS-CoV-2. To provide a more complete picture of a patient’s respiratory health, the NxTAG CoV Extended Panel can also be run in parallel with the NxTAG® Respiratory Pathogen Panel (RPP).

Luminex is actively supporting laboratories in the US, Asia, and Europe with their testing, and the company has expanded its manufacturing capacity to produce up to 300,000 NxTAG tests per month, with the majority of that capacity focused on SARS-CoV-2.

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Source: PR Newswire
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