Luminex received FDA Emergency Use Authorization for ARIES SARS-CoV-2 assay to detect virus responsible for COVID-19 disease

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On Apr. 6, 2020, Luminex announced announced that the FDA has issued an Emergency Use Authorization for its ARIES SARS-CoV-2 Assay for rapid detection of the virus that causes COVID-19. The assay runs on the ARIES System, an FDA-cleared, sample-to-answer, automated, on-demand molecular diagnostic platform. The system is capable of running up to 144 tests per day, requiring no specialty training and minimal human interaction.

Luminex also launched the NxTAG® CoV Extended Panel last week after receiving an EUA from the US FDA and Medical Device Authorization for importation or sale for Health Canada. The panel is a high-throughput, scalable, cost-effective option for detecting SARS-CoV-2 in as many as 96 samples in approximately four hours. 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.

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 200,000 ARIES® SARS-CoV-2 tests per month, in addition to 300,000 NxTAG tests per month, with the majority of this capacity focused on SARS-CoV-2.

INOVIO has assembled a global coalition of collaborators, partners, and funders to rapidly advance INO-4800. The scientific team at the Wistar Institute has provided key research contributions. The INOVIO program has been supported by generous funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and the Bill and Melinda Gates Foundation.

VGXI, a wholly-owned subsidiary of GeneOne Life Science (KSE: 011000) and INOVIO’s manufacturing partner for the last 13 years, enabled the expedited manufacture, testing, and release of the INO-4800 plasmid clinical product. The U.S. Department of Defense (DOD) has also funded INOVIO’s collaborator Ology Bioservices to manufacture additional doses of INO-4800.

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Source: PR Newswire
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