FORMER US FDA CHIEF SAYS ANTIGEN TEST IS ‘GAME-CHANGER’
US approval of a new antigen test to rapidly screen people for the coronavirus “is a real game-changer,” said the former head of the US Food and Drug Administration (FDA). The emergency use authorisation — the first ever by the FDA for a Covid-19 antigen test — was granted to San Diegobased Quidel Corp late on Friday, according to the agency.
The move could mark a breakthrough in screening for the virus and comes as state and local governments ease lockdown orders and businesses begin reopening across the nation — and as health professionals argue that swift screening is essential to temper new outbreaks. “It’s a very rapid test that could be used in a doctor’s office,” former FDA commissioner Scott Gottlieb said on Sunday on CBS’S Face the Nation. “Doctors now have about 40,000 of these Sophia machines already installed in their offices” where they are used to test for strep throat and flu, he said.
Each test will probably cost about $5, with results available within minutes, said Gottlieb, now a special partner at New Enterprise Associates, a venture capital firm that invests in the health-care and biotech sectors.
A big challenge will be what guidance is made by US authorities about how doctors test in their offices, he said, “If turning over a positive case in your medical office means that you have to do a deep cleaning and quarantine your nursing staff and close your office, doctors aren’t going to be testing.”
Deborah Birx, a member of the White House coronavirus task force, said in April that a “breakthrough innovation” in antigen testing was needed to speed reopening of the economy.
J&J PLANS FOR 1BN VACCINES IN 2021
Drug maker Johnson & Johnson will begin clinical trials on a Covid-19 vaccine in September and plans to produce about 1 billion doses in 2021, chief scientific officer Paul Stoffels told ABC. “We will have some vaccine available this year but it all depends on the authorities, the FDA and others, to decide whether it can be used earlier, before clear efficacy data are available.”