www.fdanews.com/articles/198851-roche-sets-late-september-european-launch-date-for-rapid-covid-19-test
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Roche Sets Late September European Launch Date for Rapid COVID-19 Test
September 3, 2020
Roche has announced it will launch a SARS-CoV-2 rapid antigen test in Europe later this month with help from SD BioSensor, a global in-vitro diagnostics company that operates in South Korea, India and China.
The company will begin marketing the 15-minute COVID-19 diagnostic in countries that accept the CE mark in “late September.” The test is designed for use in point-of-care settings for detecting COVID-19 in both symptomatic and asymptomatic patients who have been exposed to the virus.
Roche said it is planning to seek Emergency Use Authorization from the FDA for the instrument-free test kit.