Los Angeles to settle lawsuit against Chinese company that offered customers at-home coronavirus test kit
Officials in Los Angeles said Monday that the city is settling a lawsuit against a Chinese genetic testing company that authorities said falsely claimed it could ship thousands of test kits to accurately screen customers for coronavirus at home.
For $39, Yikon Genomics said on its website, in a press release and in a series of posts to Twitter that with “a simple finger stick procedure” its tests could “confidently screen for the (COVID-19) antibodies” in 15 minutes, marketing them as a “one step” test kit.
In a final, triumphant tweet on March 18, Yikon said “our COVID-19 Test Kit is now FDA Approved” and shared a hyperlink to a Wall Street Journal story.
That wasn’t true, said L.A. City Attorney Mike Feuer.
“That’s not what the Wall Street Journal article said,” Feuer said Monday. “The FDA has not approved any home test kit.”
The city attorney’s office filed its complaint last week against Yikon Genomics and its U.S. CEO Brandon Richard Hensinger. Court documents show the company agreed to settle the lawsuit on Friday.
The settlement agreement included requirements that Yikon Genomics refund any customers who bought the kits. And the company must immediately stop selling and advertising them.
Feuer said Monday that a one-step test kit that could accurately test for coronavirus exposure does not exist. He said the pandemic has led to a rise in companies like Yikon claiming they’ve developed a test that customers could easily administer themselves.
“Accurate testing for this virus — it involves carefully swabbing the nose or throat to collect a sample, placing it in a sterile tube, storing it below 46 degrees Farenheit, and shipping it to a lab within three days,” he said. “A number of things could easily go wrong if consumers fail to take any of these steps with precision.”
The FDA, too, noted a rise in claims of the availability of at-home test kits as the coronavirus pandemic continues to infects hundreds of thousands in the U.S. The nationwide death toll soared past 10,000 on Monday.
“Fraudulent health claims, tests, and products can pose serious health risks,” FDA officials said on their website. “They may keep some patients from seeking care or delay necessary medical treatment.”
The FDA left open the possibility of approval of an at-home test kit in the future, saying “we are actively working with test developers in this space.” In the meantime, officials said anyone showing symptoms of the virus should consult with their doctor about the process for getting a test.
The city and county of Los Angeles are providing residents with free tests. Feuer’s office said Monday that anyone who needs a test should sign up at lacovidprod.service-now.com/rrs.
By Monday, Yikon Genomics took down its tweets and a website touting the at-home test kit.
The company, based in China but with a U.S. arm operating out of Foster City, California, describes itself as “a global genetic laboratory, responsible for introducing innovative solutions in reproductive genetics, oncology, life sciences, and more.”
Yikon specializes in genetic testing of embryos destined for in vitro fertilization. The company said it launched U.S. clinical operations last year.
Reached by phone, Hensinger said he was not immediately available for comment. In identical statements Monday, both the company and Hensinger said on their Twitter accounts that they were seeking FDA approval of the test kits.
“Yikon Genomics is committed to complying with all state & federal laws and regulations regarding the marketing & sale of medical devices,” the statement read. “We intend to pursue FDA approval for the market & sale of COVID-19 test kits, which we hope will aid in mitigating this global health crisis.