Los Angeles City Attorney Mike Feuer has reached a settlement with a California company accused of advertising and selling an at-home test for COVID-19 despite a lack of approval from the U.S. Food and Drug Administration for any at-home test.
Yikon Genomics Inc. and Brandon Hensinger, the CEO of the Foster City, California-based company, have agreed to cease marketing and selling test kits and to provide full refunds to any consumers who purchased them. According to a complaint filed Friday in Los Angeles Superior Court, Yikon and Hensinger registered the domain “thecoronavirustestkit.com” and advertised a “SARS-COV-2 IgG/IgM Home Screening Kit” for sale for $39 as concerns about the virus increased in the U.S. According to the complaint, the site, which as of Monday afternoon was no longer publicly accessible, claimed that the screening test used a “simple finger stick procedure” to test for COVID-19 antibodies in the bloodstream to detect a current or recent infection of the virus behind the current global pandemic.
“The contagious transmission of COVID-19 is matched only by the infectious spread of confusion, misinformation, and consumer scams and frauds regarding this novel coronavirus,” wrote Deputy City Attorney William Pletcher in the complaint filed Friday. “Whenever consumers are motivated in part by fears, they are particularly vulnerable to fraudsters, scammers, and ‘snake oil’ hucksters and charlatans who prey on those fears to persuade the consumers to seek ‘cures,’ ‘treatments,’ and other protections, such as tests,” he wrote.
As part of the deal to settle the civil enforcement action, the company and Hensinger stipulated that they had violated California’s unfair competition and false or misleading advertising laws by selling and promoting an “FDA-approved, at-home test kit” and agreed to cease selling and promoting the test until receiving FDA approval. The company also agreed to pay a full refund to all customers who purchased the test so far.
Pepper Hamilton partner Allison DeLaurentis in Philadelphia, who represents the company and Hensinger in the matter, on Monday passed along an email statement on their behalf.
“Yikon Genomics is committed to complying with all state and federal laws and regulations regarding the marketing and sale of medical devices,” the statement said. “We intend to pursue FDA approval for the market and sale of COVID-19 test kits, which we hope will aid in mitigating this global health crisis.”