Austin, Texas-based Luminex runs the test on its FDA-cleared Aries system for sample-to-answer, automated, on-demand molecular diagnostics. Aries is capable of running up to 144 tests per day with no specialty training and minimal human interaction, according to a news release.
The company intends to scale up production of the assay over the next three weeks to support hundreds of labs in the U.S. and globally that are already operating the Aries system and can get the test running quickly once it is broadly available.
“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,” Luminex president & CEO Nachum Shamir said in the release. “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.”
Last week, Luminex launched its NxTag CoV extended panel after receiving EUA and authorization in Canada as well. The panel is designed to detect SARS-CoV-2 in as many as 96 samples in approximately four hours.
With both EUAs, Luminex has expanded its manufacturing capacity to produce up to 200,000 Aries SARS-CoV-2 tests per month, along with 300,000 NxTag tests per month.
Both the panel and assay were funded with $642,450 in federal funds, worth about 36% of each of the expected overall cost of development, from the U.S. Dept. of Health & Human Services, Office of the Assistant Secretary for Preparedness & Response, Biomedical Advanced Research & Development Authority and the Division of Research Innovation & Ventures. Luminex funded the remaining amounts of each program, totaling more than $1.1 million, according to the release.