Luminex (NSDQ:LMNX) announced today that it received FDA emergency use authorization (EUA) for its xMAP SARS-CoV-2 multi-antigen IgG assay for COVID-19.
Austin, Texas-based Luminex said in a news release that its serology assay can identify the presence of antibodies in those who have been infected with the SARS-CoV-2 virus causing COVID-19. The newly authorized assay can run on any of Luminex’s xMAP-based, high-throughput multiplex platforms, including MAGPIX, the Luminex 200, and FLEXMAP 3D.
The company’s xMAP assay delivers results for up to 96 patient samples in under three hours, detecting antibodies of the IgG antibodies at a specificity of 100% in human serum and more than 99% in human plasma, according to results from clinical studies.
“More than 17,000 xMAP systems have been sold to laboratories around the world, and this FDA authorization creates important new opportunities for these labs to rapidly expand their COVID-19 testing capabilities with a highly accurate serology-based assay,” Luminex president & CEO Nachum Shamir said in the release. “In close collaboration with our extensive network of partners and customers, Luminex continues to be on the frontlines in the mission-critical effort to address the current pandemic with state-of-the-art testing and innovative technologies such as xMAP.”
Luminex’s antigen assay is the first of the company’s multiple serology tests in development to receive EUA, while the company already had two diagnostic tests receive authorization in the earlier stages of the pandemic.