Luminex Receives BARDA Award to Support Enhancement of COVID-19 Multiplex Antibody Test

Luminex Corporation received an award of $683,500 from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, to support the enhancement of the company's xMAP® SARS-CoV-2 Multi-Antigen IgG Assay. The company intends to submit this enhanced serology assay for an Emergency Use Authorization when this project is completed.

The xMAP SARS-CoV-2 Multi-Antigen IgG Assay detects antibodies to three different viral antigens—the spike protein, nucleocapsid, and receptor-binding domain—to assess if a person has been infected with SARS-CoV-2. In this new BARDA-funded project, information from all three of these antigens will be integrated to provide a more comprehensive view of a person's immune status. By combining all of this information in one assay, Luminex seeks to create a test that not only identifies prior infection, but also assesses the neutralizing activity of the immune response.

This information is more important than ever with millions of confirmed cases of COVID-19 around the world, and the first proven cases of reinfection having already occurred. As people return to work, students head back to school, and vaccines become available, communities will need to understand the extent to which past infections provide protection against future SARS-CoV-2 infections.

"Throughout the COVID-19 crisis, we have sought to develop tests based on the latest research and the most immediate clinical needs. In addition to our SARS-CoV-2 tests that detect active coronavirus infections, we believe that advanced serology assays will be instrumental in understanding who has been infected," said Nachum "Homi" Shamir, Chairman, President and CEO of Luminex. "We appreciate BARDA's support as we continue to develop solutions that can help improve patient outcomes during this global pandemic."

The currently available xMAP SARS-CoV-2 Multi-Antigen IgG Assay delivers high-quality results for up to 96 patient samples in less than four hours. The assay has demonstrated specificity of 100 percent in human serum and greater than 99 percent in human plasma, with sensitivity greater than 96 percent for both human serum and plasma (more than 14 days post-symptom onset) in clinical studies. The assay, which can be run on any of Luminex's xMAP-based high-throughput platforms, uses advanced multiplexing capabilities to reduce the risk of false positives and false negatives. The U.S. Food and Drug Administration granted Emergency Use Authorization for this assay on July 20, 2020.

This project has been funded at approximately 37% of the expected overall cost of development with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, Division of Research Innovation and Ventures under Contract No. 75A50120C00179.

SOURCE Luminex Corporation

Related Posts

Subscribe Our Newsletter