FDA clears new COVID-19 tests producing results in minutes
A Los Angeles-based company, Bodysphere Inc., announced today it would begin distributing serological testing kits for diagnosing the novel coronavirus (COVID-19) after receiving Emergency Use Authorization from the U.S. Food and Drug Administration (FDA). The kits can detect a positive or negative result for COVID-19 in two minutes.
The Bodysphere Inc. test can only detect COVID-19 in patients who have had the infection for several days. This means administering the test too early could produce a false negative result.
Though access to testing has improved in the U.S., the average wait time for a patient’s results is four to five days, and in some cases a week or more. The FDA has responded by rushing to approve tests from companies that promise quicker results.
Earlier this week, Abbott Laboratories receive emergency authorization from the FDA to producer portable COVID-19 tests, which the company states can detect the virus within five minutes.
“The [FDA] has been providing unprecedented flexibility to labs and manufacturers to develop and offer COVID-19 tests across the U.S.,” the agency said in a press statement. “The FDA’s regulations have not hindered or been a roadblock to the rollout of tests during this pandemic.”