Luminex Gains EUA for Diagnostics as Demand for COVID-19 Tests Soars

Luminex can be added to the list of companies that have received Emergency Use Authorization (EUA) for a diagnostic to address the coronavirus (COVID-19) pandemic. The Austin, TX-based firm was granted the designation for the Aries SARS-CoV-2 Assay for the rapid detection of the virus that causes COVID-19. The assay runs on the Aries System, which is cleared by FDA and has the capability of running up to 144 tests per day. Recently Luminex received another EUA in addition to Medical Device Authorization for importation or sale for Health Canada for the NxTAG CoV Extended Panel. The company said the panel is a high-throughput, scalable, cost-effective option for detecting SARS-CoV-2 in as many as 96 samples in approximately four hours. Currently, the demand for COVID-19 tests in the U.S. is off the charts. NPR recently reported that some companies are facing a backlog in getting samples tested. Eric Shapiro, VP of global marketing, Luminex said that even though there were tests constantly coming to the market there was still room for new tests. “There’s not enough capacity to fit the demand,” Shapiro told MD+DI. “So, every company that’s out there right now that can help to fill this demand is important.” In a release Luminex said the NxTAG CoV Extended Panel and the Aries SARS-CoV-2 Assay have each been funded with $642,450 of Federal funds, abou...
Source: MDDI - Category: Medical Devices Authors: Tags: IVD Source Type: news