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Luminex Receives FDA Emergency Use Authorization for Second SARS-CoV-2 Assay

NEW YORK – Luminex said Monday that the US Food and Drug Administration has issued an Emergency Use Authorization (EUA) for its Aries SARS-CoV-2 Assay for rapid detection of the virus that causes COVID-19.

The assay runs on the FDA-cleared Aries System, a sample-to-answer molecular diagnostic platform that can perform 144 tests per day. It will allow hospital professionals to determine the appropriate course of treatment for patients suspected of having COVID-19 within approximately two hours, Luminex said.

"We are scaling up production of this assay over the next three weeks to support hundreds of labs across the US and the rest of the globe," Nachum Shamir, President and CEO of Luminex, said in a statement. "These labs are already operating the Aries System and should be able to get up and running very quickly as we make this test broadly available."

Luminex said it launched its NxTag CoV Extended Panel last week, after receiving an FDA EUA and Medical Device Authorization from Health Canada for importation or sale.

The NxTag CoV Extended Panel ─ a high-throughput, scalable test for detecting SARS-CoV-2 in 96 samples in approximately four hours ─ can be run in parallel with the firm's NxTAG Respiratory Pathogen Panel to provide a more complete picture of a patient's respiratory health, Luminex said.

The NxTAG CoV Extended Panel and the Aries SARS-CoV-2 Assay have each been funded with $642,450 from the Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA). Luminex said it financed the remaining $1.1 million of each program.

The firm said it is supporting laboratories in the US, Asia, and Europe with testing. Further, the company  has expanded its manufacturing capacity to produce up to 200,000 Aries SARS-CoV-2 tests per month and 300,000 NxTag tests per month, with the majority of the capacity focused on SARS-CoV-2.