Industry News: BARDA and Luminex Corporation enter into a public-private partnership to develop an advanced serology test for use during the COVID-19 pandemic

24 Sep 2020

BARDA and Luminex Corporation entered into a partnership to develop a cost-effective, high throughput test that assesses the level of neutralizing antibodies in plasma. 

This advanced serology effort builds on the Emergency Use Authorized (EUA) xMAP® SARS-CoV-2 Multi-Antigen IgG assay, which is a multiplex, microsphere-based, highly sensitive and specific assay that detects the presence of antibodies against three different SARS-CoV-2 antigens. This current test determines if a patient has previously had a COVID-19 infection.

While the immune response to a past COVID-19 infection may protect against reinfection, an important aspect of understanding this potential protection is neutralization activity, or the ability of antibodies to bind with and prevent SARS-CoV-2 from interacting with human cells. Current methods of determining neutralization activity are time-consuming, expensive, and not available for the clinical setting.

To make estimates of neutralization more broadly available to healthcare professionals, Luminex is modifying the xMAP® SARS-CoV-2 Multi-Antigen IgG test. The team will compare the type and quantity of antibodies against three viral antigens – the spike protein, nucleocapsid, and receptor-binding domain – to the current “gold standard” measures of neutralization activity.

The new test will run on the MAGPIX®, Luminex 200™, and FLEXMAP 3D® platforms. Having multiple diagnostic platforms available for COVID-19 testing provides patients, healthcare providers, and public health officials with reliable information to limit transmission of the virus, treat infections and save lives.

Upon successful development, the company will seek Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration.

This award is one component of BARDA’s Rapidly-Expanding COVID-19 medical countermeasure portfolio.

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