New FDA guidelines could enable at-home virus testing
Updated: May 29
The Food and Drug Administration posted new guidelines on Thursday that could significantly expand testing capacity and potentially enable millions of Americans to test themselves for the novel coronavirus at home.
The guidelines allow businesses to develop and market testing kits with the tools to swab their noses and mail the samples to any lab in the country. The FDA says it hopes the new guidelines will greatly boost the availability of tests by encouraging manufacturers to mass-produce home test kits.
“We are cutting the red tape to ease and expedite the development and agency review of novel tests,” Dr. Stephen M. Hahn, the F.D.A. commissioner, said in statement.
The FDA acted after it extensively reviewed studies determining the viability of self-collected samples that spent three days in a dry plastic tube and the accuracy of the testing method. The approval of the new guidelines was months in the making. It had been repeatedly delayed as agency scientists requested additional data to ensure that at-home test specimens could endure a journey through the postal system or several days in street-side collection bins awaiting pickup by Fed Ex and other courier companies.
The new FDA guidance could provide a much-needed alternative to current coronavirus testing, which requires patients to visit a clinic or hospital staffed by health workers who must frequently change protective gear that remains in short supply.
Dr. Eric Topol, the director of the Scripps Translational Science Institute, said that inexpensive, mass-produced diagnostics could help states that lack the necessary testing capacity to ease shutdowns and social distancing guidelines. “The only way to get our arms around this pandemic is to enable millions of people to get tested,” he said. “Home testing is really the only way to do it.”