Luminex Gets EUA from FDA for SARS-CoV-2 Test

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Molecular diagnostics and assay development company Luminex announced today that its ARIES SARS-CoV-2 Assay for rapid detection of the virus that causes COVID-19 has received and Emergency Use Authorization from the FDA. According to the company, the test will run on its FDA-approved ARIES system an automated system that can run up to 144 tests per day and deliver results in about two hours.

“We are grateful to the FDA for this Emergency Use Authorization, which allows us to bring another cost-effective SARS-CoV-2 test from Luminex to labs and patients in dire need of quick, accurate results,” said Nachum “Homi” Shamir, president and CEO of Luminex, in a press release.

Shamir noted that the company is currently scaling up production of the test and is planning for global distribution focused on labs that are already operating the ARIES platform to allow them to be up and running quickly.

In addition to the EUA for the ARIES System, Luminex said it also launched the NxTAG CoV Extended Panel last week after receiving an EUA from the FDA and Medical Device Authorization for importation or sale for Health Canada. The high-throughput panel, can detect SARS-CoV-2 in as many as 96 samples in approximately four hours and can be run in parallel with its respiratory pathogen panel to provide a more comprehensive view of a patients respiratory health.

Both the SARS-CoV-2 Assay and extended panel were funded with $642,450 of Federal funds, approximately 36% each of the expected overall cost of development, from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response, with Luminex financed the remaining $1,118,663 of each program, constituting 64% each of the total program costs.

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.

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