Sen. Chuck Schumer says “we are here to sound the alarm” on coronavirus and antibody tests sold online that are not approved by the FDA. Schumer urges the FDA to “ramp up policing of these online tests.”
Amid the haste to develop antibody testing, we may be setting ourselves up for disaster.
A healthcare professional takes blood to test for antibodies at Mt. Sinai Hospital as the spread of the coronavirus disease continues in the Manhattan borough of New York City, April 25, 2020. The federal guidance that does exist confuses things even more, according to Wells, who added,"The FDA doesn't even say what validation is." Different tests"are coming out with different amounts of data, different levels, huge gaps and frankly some even pretty unbelievable results.
Senior officials from the FDA told ABC News they recognize there is a large ecosystem of antibody testing and providers are hungry to use them and in response want to provide much-needed clarity. The FDA said through its collaboration with the NIH and CDC it will physically validate the tests rather than review paperwork received by companies applying for the emergency use authorization. Generally the tests it is reviewing have been volunteered by the companies.
In response to this recent staff memo FDA Commissioner Stephen Hahn said at the White House briefing on Friday,"We provide flexibility." Hahn said the FDA, with the CDC and NIH will work to provide"as much information as we possibly can" about these tests' efficacy.
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