U.S. medical device maker Becton Dickinson and Co said on Wednesday its COVID-19 antigen test kit met the requirements for a launch in Europe.
The approval comes as the region struggles with insufficient COVID-19 tests and long waits for results, while it battles a resurgence in infections.
The test, which can be performed in a portable device and does not require a lab, has been available in the United States since July through an emergency use authorization by the U.S. Food and Drug Administration.
Becton said it expects its test to be commercially available for European countries that recognise the CE mark by the end of October.
The CE mark indicates the company has run tests to validate that the product meets requirements in the European Union, where market access for medical devices is not controlled by a regulator.
Antigen tests scan for viral surface proteins, and are faster and cheaper than standard PCR tests, which analyse the entire viral genome. But they have so far been slightly less reliable than PCR tests at filtering out all of those who are infected.
The company said it expects to produce 8 million SARS-CoV-2 antigen tests per month by October and 12 million tests per month by March 2021. (Reporting by Rama Venkat in Bengaluru and Ludwig Burger in Frankfurt; Editing by Ramakrishnan M.)