via: https://www.biospace.com/article/roche-prepares-to-launch-covid-19-antibody-test-system
Swiss pharma giant Roche is joining the race to develop a test for COVID-19 antibodies in people who have been exposed to the disease.
This morning, Roche announced the development and upcoming launch of its Elecsys Anti-SARS-CoV-2 serology test to detect antibodies in people who have been exposed to the SARS-CoV-2, the virus that causes COVID-19. Roche is eying May for the launch of the test in Europe and is in talks with the U.S Food and Drug Administration for emergency approval of the system.
Antibody testing is central to help identify people who have been infected by the virus, especially those who may have been infected but did not display symptoms, the company said. Roche noted that as more information becomes available about immunity levels to COVID-19, society can return to a sense of normal much more quickly.
Roche’s test will join a number of other antibody tests that have recently come on the market. Earlier this month the U.S. Food and Drug Administration approved the first blood test for COVID-19 antibodies. Research Triangle Park, N.C.-based Cellex was granted an Emergency Use Authorization (EUA) for its test. This week, the FDA approved Ortho Clinical Diagnostics’ VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrators, a high-throughput, automated COVID-19 antibody test. Abbott Laboratories has also launched an antibody test. Abbott’s SARS-CoV-2 IgG test identifies the IgG antibody, which is a protein that the body produces in the late stages of infection.
For Roche, the development of its Elecsys test follows EUA of its cobas SARS-CoV-2 Test for the presence of the virus in the body. Hospitals and laboratories will be able to run the test on Roche’s fully automated cobas 6800 and cobas 8800 Systems, which are already in wide use in the U.S. and internationally, Roche said when the test won approval in March.
“Following the launch of our high-volume PCR test in mid-March to detect active infection of the disease, we are now going to launch a new antibody test in early May. Every reliable test on the market serves its purpose for healthcare systems to help us overcome this pandemic. Roche is collaborating closely with health authorities and ramping up production to ensure fast availability of the test globally,” Roche Chief Executive Officer Severin Schwan said in a statement.
The Elecsys Anti-SARS-CoV-2 immunoassay is an in vitro test, which uses human serum and plasma drawn from a blood sample to detect antibodies and determine the body’s immune reaction to SARS-CoV-2. The test will be able to be run on Roche’s cobas analyzers, which, as noted above, are already in wide use across the globe. Roche said the test can provide results in approximately 18 minutes and expects the systems to provide results for roughly 300 tests per hour.
Roche said it is planning on an accelerated ramp-up of monthly production to high double-digit million tests by June and will further scale up production as fast as possible.
“Roche is deeply committed to supporting the global response to the COVID-19 pandemic,” Thomas Schinecker, CEO of Roche Diagnostics said in a statement. “Timely availability and fast access to reliable, high-quality tests are essential for healthcare systems. The antibody test is an important next step in the fight against COVID-19. Roche’s antibody test can be quickly scaled and made broadly available around the world as our instrument infrastructure is already in place.”
By Alex Keow
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