Premature at-home COVID-19 test kit makers probed by Congress
Three companies that marketed and sold unauthorized COVID-19 test kits are under congressional scrutiny, U.S. Rep. Raja Krishnamoorthi said Wednesday.
The U.S. Food and Drug Administration on Friday warned the public that it has not authorized any at-home tests for COVID-19, a respiratory disease that can cause pneumonia.
"A variety of companies have gone out and tried to sell these unauthorized kits," said Krishnamoorthi, a Schaumburg Democrat and chairman of the House Oversight Committee's Subcommittee on Economic and Consumer Policy.
Selling test kits that allow consumers to collect their own saliva and send to labs for testing is "wrong and illegal" without FDA approval, he said.
Krishnamoorthi's subcommittee sent letters to three test-kit producers Wednesday asking: when they started and stopped offering test kits; how many were sold and at what cost; and how many consumers returned samples for testing.
The committee also wants to know how consumers will be refunded.
"People are scared and nervous about the coronavirus pandemic," Krishnamoorthi said, and businesses should not be taking advantage of consumers' anxiety.
The FDA has asked people who are aware of any at-home test kits to report them to FDA-COVID-19-Fraudulent-Products@fda.hhs.gov; Krishnamoorthi also asked consumers to call his office at (202) 225-3711.
The companies targeted by the subcommittee are San Francisco-based Carbon Health Medical Group Inc. and Nurx Inc. and Austin-based Everlywell.
A Nurx spokeswoman said the company's at-home tests were validated by an accredited laboratory, were offered at cost and were designed for symptomatic and at-risk patients.
The company paused the testing service a day after hearing from the FDA and has refunded 181 consumers who used the kits, she said.