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www.fdanews.com/articles/199538-roche-plans-to-have-high-volume-covid-19-test-available-in-europe-by-end-of-2020
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Roche Plans to Have High-Volume COVID-19 Test Available in Europe by End of 2020

October 14, 2020

Roche has announced plans to make a high-volume COVID-19 immunoassay available in CE mark-accepting countries at the end of the year.

The company’s Elecsys SARS-CoV-2 Antigen immunoassay, a highly accurate lab test for COVID-19, uses nasopharyngeal or oropharyngeal swabs from patients suspected of being infected or patients exposed to the virus. The test runs on all cobas e immunochemistry analyzers and can provide results in 18 minutes, and up to 300 tests can be run per hour depending on the analyzer used.

The company also said it plans to submit the test to the FDA for Emergency Use Authorization as well.

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