Policy & Regulation
Luminex passes FDA EUA for NxTAG CoV extended panel to detect the SARS-CoV-2 under BARDA award
30 March 2020 -

Clinical diagnostics company Luminex Corporation (NASDAQ:LMNX) revealed on Friday the receipt of Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for its high-throughput, scalable, cost-effective NxTAG CoV extended panel for the detection of the SARS-CoV-2 virus.

According to the company, the high complexity molecular laboratories can now use the NxTAG test on its easy-to-use, compact MAGPIX System to rapidly detect the virus that causes COVID-19 disease for up to 96 patients in approximately four hours.

Based on the company's bead-based chemistry, the MAGPIX System is both easy to run and to use, providing a cost-effective testing solution for the rapid delivery of results. The NxTAG CoV Extended Panel can be run in parallel with the NxTAG Respiratory Pathogen Panel (RPP).

In conjunction, 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.

Additionally, the company received USD642,000, which is 36% of the total programme cost, through from the Biomedical Advanced Research and Development Authority (BARDA) to develop and validate the NxTAG SARS-CoV-2 Test. This project has been funded in whole or in part with federal funds from the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response and Biomedical Advanced Research and Development Authority, Division of Research Innovation and Ventures.

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