A five-minute, point-ofcare coronavirus test could be coming to urgent care clinics next week, and experts say it could be "gamechanging."
The U.S. Food and Drug Administration issued Emergency Use Authorization to Illinois-based medical device maker Abbott Labs on Friday for a coronavirus test that delivers positive results in as little as five minutes and negative results in 13 minutes, the company said.
The company expects the tests to be available next week and expects to ramp up manufacturing to deliver 50,000 tests per day.
Unlike high-throughput batch testing platforms that can run hundreds of tests at a time but take several hours, the ID NOW platform is a bench-top instrument used at physician offices and urgent care clinics. The platform is typically used to run tests for other respiratory illnesses, such as the flu, strep and RSV – and similarly uses samples from throat and nose swabs.
"I am pleased that the FDA authorized Abbott's pointof-care test yesterday. This is big news and will help get more of these tests out in the field rapidly," FDA Commissioner Steve Hahn said in a statement. "We know how important it is to get pointof-care tests out in the field quickly. These tests that can give results quickly can be a game changer in diagnosing COVID-19."
Other companies have also received emergency use authorization from the FDA, which allows for the use of unapproved medical devices during a public health emergency.
California-based Cepheid said last week that it received authorization for a test the company says gives results within 45 minutes. Another California-based company, Mesa Biotech, said Tuesday that it received authorization for a palm-sized test that the company says gives results in 30 minutes. The test is intended for use at temporary screening facilities, physician office labs, urgent care and long term nursing facilities.
"We believe that this pandemic is going to be fought at a number of levels, starting with the diagnostic front being able to clear the backlogs in testing. That's done by making high-volume throughput tests available and at the front lines as patients present themselves at urgent care," John Frels, Abbott's vice president of research and development said.
Abbott did not immediately say if it planned to manufacture more ID NOW platforms, in addition to the new test cartridges. Company spokesperson Darcy Ross said the company was working with the Trump administration to determine where the tests would be sent.