FDA issues emergency authorization to Luminex for assay to detect COVID-19 virus

Luminex (Austin, TX) has been issued an Emergency Use Authorization (EUA) from the U.S. FDA for its ARIES SARS-CoV-2 Assay for rapid detection of the virus that causes COVID-19. The assay runs on the ARIES System, a U.S. 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.

"The ARIES SARS-CoV-2 Assay will allow hospital professionals to determine the appropriate course of treatment for patients suspected of having COVID-19 within approximately two hours," says Nachum "Homi" Shamir, president and CEO of Luminex. The company is scaling up production of the assay over the next three weeks to support hundreds of labs already operating the ARIES system across the U.S. and worldwide, he says.

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. 

For more information, please visit luminexcorp.com.