The U.S. Food and Drug Administration last week granted emergency use authorization for Roche's Elecsys Anti-SARS-CoV-2 molecular blood test, which works by detecting antibodies sent from the body's immune system to fight the spike protein "crown" of the novel coronavirus that causes COVID-19.
Detecting the presence and levels of the antibodies can be used to determine if a person has been infected and whether they have potentially developed an immunity to the virus. It can also be used to monitor how well a vaccine is working.
Preliminary results from Moderna's late-stage vaccine clinical trials have shown it is 94% effective in blocking COVID-19.
The FDA has scheduled a meeting for Dec. 17 to determine whether to grant emergency approval for Moderna's vaccine. The company says it expects to have 20 million doses available in the United States by the end of the month.
Moderna's vaccine activates an antibody response to proteins found on the coronavirus' binding spikes, meaning Roche's test can be useful in measuring a patient's response over time, Roche Diagnostics CEO Thomas Schinecker said.
"We are pleased to see that our quantitative Elecsys SARS-CoV-2 S test, which targets the spike protein, is now also being used as part of the Moderna vaccine trials, which could ultimately help to end this pandemic," he said.
Roche's antibody test received approvals in the European Union in September. It said it will begin shipping kits to U.S. laboratories this week, with the first going to national diagnostics firm LabCorp.
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