The commissioner for the Food and Drug Administration announced that a new antibody test had been authorized for determining previous cases of COVID-19.
Commissioner Stephen Hahn announced on Thursday morning that the administration had granted laboratories the flexibility to start using a test that can determine whether someone was previously infected with the coronavirus and is now immune to catching the illness. He told CBS Radio that the tests are not formally FDA approved, but that the administration had cut restrictions to fast-track access to the tests.
“We are going to announce today the approval, our first approval of a serology test, which will, in laboratories, allow us or allow the labs to determine exposure in the antibodies. We have provided regulatory flexibility to other laboratories and other producers so that they can develop their own tests,” Hahn said.
He continued, “We posted on our website those companies that have said they have tests, and they’re coming into market, remembering, of course, that those aren’t FDA approved but we’ve given them the flexibility to go forward as long as they’ve done their own quality assurance of those tests.”
JUST IN: @US_FDA announces approval of #COVID19 antibody test in @CBSNewsRadio interview. pic.twitter.com/zvWINTn3lK
— Steven Portnoy (@stevenportnoy) April 2, 2020
Hahn noted that Dr. Deborah Birx, a top doctor on the White House coronavirus task force, requested during a press conference on Wednesday night that laboratories in universities gear up to begin testing antibodies by the end of the week. Birx noted that such tests could protect healthcare workers who would benefit from knowing they are immune to the virus.
“We’ve made a call to hospitals and academic labs to ramp up by Friday their own test development, and we’ve given complete flexibility for them to do that,” Hahn said. “These are high-quality labs. So we’re expecting a significant expansion over the next couple of weeks. We want to use that both in the laboratory setting but also in the public health setting so we can do the sort of surveillance that Dr. Birx was talking about.”
Coronavirus does not present significant symptoms in all who contract the virus, meaning that many people may not know they have already overcome the virus and are no longer susceptible.
