FDA Clears BodySphere’s Two Minute COVID-19 Diagnostic for Emergency Use
The FDA has granted BodySphere an emergency use authorization for its Two-Minute Testing Kit for detecting the novel coronavirus.
The diagnostic uses antibodies in the blood to test for both current and past infection. The test has a 99 percent sensitivity rate.
Most COVID-19 tests in the U.S. currently take from two to seven days to deliver results, the company noted, calling its product “a game changer.”