Roche announced plans to launch its own COVID-19 antibody blood test early next month as a complement to its previous high-throughput test for active infections authorized by the FDA in March.
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The company’s Elecsys Anti-SARS-CoV-2 serology test is designed to identify people who have previously been infected by the virus, especially those who may not have displayed symptoms, by detecting the body’s immune response to the infection.
“Every reliable test on the market serves its purpose for healthcare systems to help us overcome this pandemic,” CEO Severin Schwan said in a statement. “Roche is collaborating closely with health authorities and ramping up production to ensure fast availability of the test globally.”
The antibody diagnostic could also support screening of high-risk groups, such as healthcare and food supply workers, and potentially allow them to return to work with a measured immunity to the disease, according to the company.
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Designed for Roche’s cobas analyzers, the blood test could also be used in epidemiological research to better track the global spread of the coronavirus. The fully-automated hardware can provide COVID-19 results in about 18 minutes and process up to 300 tests per hour with certain equipment.
"The antibody test is an important next step in the fight against COVID-19,” said Thomas Schinecker, CEO of Roche’s diagnostics division. “Roche’s antibody test can be quickly scaled and made broadly available around the world as our instrument infrastructure is already in place.”
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The company said it is working with the FDA to secure an Emergency Use Authorization, though the agency is currently allowing developers to distribute validated serology tests ahead of official review.
Roche also plans to launch the test in European countries accepting the CE mark and said it is aiming for monthly production in the “high double-digit” millions by June.