'We have the wild, wild West for testing right now,' said Dr. Michael Osterholm.
for assessing the reach of the virus, determining potential immunity in individuals who have recovered from COVID-19, and ultimately reopening the country.
“FDA did not review any coronavirus ‘rapid’ antibody test kits before they went on the market, and a lack of enforcement by FDA has allowed manufacturers to make fraudulent claims about their efficacy,” according to the panel’s findings.later Friday, FDA Commissioner Stephen Hahn said President Donald Trump asked his agency to “cut down as many barriers as we possibly could to get medical products out to the medical community.
“They have to validate their tests, they have to tell us that they validated their tests, and in the package insert they have to let people know ... those tests are not authorized by FDA,” he said. “We’ve authorized four. As I mention, more in the pipeline.” “We have to have a breakthrough innovation in testing,” she said. “We have to be able to detect antigen rather than constantly try to detect the actual live virus.”
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