NEW YORK – The US Food and Drug Administration on Friday granted Emergency Use Authorization to Luminex for the firm's NxTag CoV Extended Panel to detect SARS-CoV-2 virus nucleic acids in nasopharyngeal swab specimens.
High-complexity molecular laboratories can now use the NxTag test on its compact Magpix System to rapidly detect the virus that causes COVID-19 disease for up to 96 patients in approximately four hours, Luminex said.
The company said it is supporting laboratories in the US, Asia, and Europe with their testing, and it has expanded manufacturing capacity to produce up to 300,000 NxTag tests per month, with most focused on SARS-CoV-2.
Texas-based Luminex had announced earlier this month that it began shipping a research-use-only version of the NxTag CoV Extended Panel, which is a multiplex PCR test that uses the firm's bead-based NxTag technology.
Earlier this week, the company had been awarded $642,000 in funding from the US Department of Health and Human Services Biomedical Advanced Research and Development Authority to develop and validate the NxTag SARS-CoV-2 test.
The NxTag CoV Extended Panel can be run in parallel with the firm's NxTag Respiratory Pathogen Panel (RPP) to provide a more complete picture of a patient's respiratory health, the firm said. An FDA-cleared product for many years, NxTag RPP has 20 targets of which four are associated with coronaviruses but none with SARS-CoV-2.
During a conference call in February to discuss its Q4 2019 financial results, Luminex said it had applied to the China National Medical Products Administration for approval and EUA of its NxTag RPP test.
Further, the firm said recently that four independent clinical laboratories had reported data from evaluation of its automated, sample-to-answer Aries system test for the rapid detection of SARS-CoV-2 virus. It anticipates submitting an EUA application for an Aries SARS-CoV-2 Assay in April.
Luminex shares were up more than 3 percent at $27.92 in afternoon trade on the Nasdaq.