BARDA, Luminex form public-private partnership dedicated to new COVID-19 serology test

In an effort to better track COVID-19 infections, the Luminex Corporation and the Biomedical Advanced Research and Development Authority (BARDA) have partnered on the creation of a more advanced serology test.

This latest effort is based on the xMAP SARS-CoV-2 Multi-Antigen IgG assay, a multiplex, microsphere-based, highly sensitive, and specific test for detecting antibodies against three SARS-CoV-2 antigens, to determine if a patient has previously been infected by COVID-19. Luminex wants to modify this test to be able to provide estimates of neutralization as well.

The difference is: immune response to past infections can protect against reinfection, but to understand it, one benefits from knowing about neutralization activity, meaning the ability of antibodies to bind with and prevent SARS-CoV-2 — the virus that causes COVID-19 — from interacting with human cells. Current methods of tracking neutralization are long, costly, and unavailable at the clinical level.

To change this, Luminex will make its new test run on the MAGPIX, Luminex 200, and FLEXMAP 3D platforms, offering multiple diagnostic platforms to allow more reliable information more flexibly. All will assess the level of neutralizing antibodies in plasma. The type and quantity of antibodies will be compared against three viral antigens within SARS-CoV-2: the spike protein, nucleocapsid, and receptor-binding domain.

Once developed, Luminex will seek Emergency Use Authorization from the U.S. Food and Drug Administration.