Luminex Receives FDA Emergency Use Authorization for its xMAP SARS-CoV-2 Multi-Antigen IgG Assay.
The Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Luminex’s xMAP SARS-CoV-2 Multi-Antigen IgG Assay today.
"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," President and CEO Nachum "Homi" Shamir of Luminex said.
"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."
This test can simultaneously detect antibodies against three antigens, and can provide up to 96 patient samples in less than 3 hours. The assay detects antibodies of the immunoglobulin class G (IgG).
For coronavirus 2019 (COVID-19) patients who are treated and recover from the virus, they typically develop IgG and IgM antibodies. Antibody tests can detect previous COVID-19 infection with high specificity and high sensitivity in clinical studies, which help provide accurate results while minimizing the risk of both false positives and false negatives.
The xMAP-based serology test is the third COVID-19 test developed by Luminex to receive an EUA, joining the NxTAG CoV Extended Panel and the ARIES SARS-CoV-2 Assay, which are rapid, RNA-based SARS-CoV-2 diagnostic tests that received EUAs in March and April of this year, respectively.
The SARS-CoV-2 Multi-Antigen IgG Assay is the first of several serology tests that Luminex is developing and plans to take to market through an EUA to help during the COVID-19 pandemic.
The company’s xMAP Technology employs a bead-based multiplexing assay approach that can rapidly detect and quantify multiple analytes in a single sample.
Luminex is based in Austin, Texas and the company is involved in clinical diagnostics, pharmaceutical drug discovery, biomedical research, genomic and proteomic research, biodefense research, and food safety.