NEW YORK – The office of Los Angeles City Attorney Michael Feuer said on Monday that it has reached a settlement with Yikon Genomics regarding a lawsuit it filed over the advertisement and sale of Yikon's at-home coronavirus test kits.
Under the settlement, Yikon agreed to immediately stop advertising, marketing, and selling its test kits and to refund customers who purchased them. It will also only sell at-home coronavirus tests in California if they are approved by the US Food and Drug Administration and comply with all rules and regulations governing the sale of medical devices in California.
"We're fighting to protect a very anxious public from falling victim to COVID-19 related schemes, including so-called at-home tests that are falsely advertised and should not be used for in-home testing," Feuer said in a statement.
"Yikon Genomics is committed to complying with all state and federal laws and regulations regarding the marketing and sale of medical devices," said Yikon Genomics global VP Brandon Hensinger in an email. "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."
The FDA has not authorized any assay yet that allows individuals to test themselves at home for COVID-19, though it has said that it sees value in tests that may include home collection and is working with test developers in this space.
Feuer's office filed a lawsuit against Yikon Genomics and Hensinger in the Superior Court of the State of California, County of Los Angeles, on April 3.
According to the complaint, Yikon registered a now-defunct website, Thecoronavirustestkit.com, on March 11, where it advertised its SARS-CoV-2 IgG/IgM At-Home Screening Kit for $39. The company claimed that the test could detect current or recent COVID-19 infections with a sensitivity of 95.04 percent and a specificity of 100 percent. In addition, on March 18, the firm on Twitter misleadingly stated that its COVID-19 test kit is FDA approved.
Yikon Genomics, cofounded by Sunney Xie, a professor at Peking University and formerly Harvard University, and headquartered in Shanghai, China, had so far been focused on preimplantation genetic testing and cancer diagnostics.