The US Food and Drug Administration has granted emergency use authorization (EUA) to Becton Dickinson and Co for a Covid-19 antigen test that can be administered at the point of care and produce results within 15 minutes, the company said on Monday.
Antigen tests are a relatively new type of test for Covid-19 that work by scanning for proteins that can be found on or inside a virus.
The FDA has touted the tests as an important tool for combating the pandemic because they can be produced quickly, at relatively low costs, and test patients in a variety of settings.
The regulator approved in May the first Covid-19 antibody test, which is made by Quidel Corp.
Becton Dickinson's test can be used on its existing BD Veritor System platform, which is employed in about 25,000 healthcare facilities across the United States.
The platform is slightly larger than a cellphone and does not need to be operated by specialized laboratory scientists, the company said. Becton Dickinson said it would be able to produce 2 million tests a week by the end of September.
Becton Dickinson has unveiled a variety of other types of tests for Covid-19 this year, and has said it is working to ramp up testing capacity in anticipation of a second wave of the virus.
"This will be a game changer for frontline healthcare workers and their patients to be able to access a quick diagnostic test for Covid-19, offering results in real time at convenient locations like retail pharmacies, urgent care centers, and doctors' offices," said Dave Hickey, president of Becton Dickinson's integrated diagnostic solutions business.