Company that sold $39 coronavirus home test kits without FDA approval settles with L.A., will issue refunds

Local News

A company that advertised and sold $39 coronavirus home testing kits in Los Angeles, falsely claiming to have federal approval, settled a civil law enforcement action with the city Monday and agreed to refund customers, the L.A. City Attorney’s Office said.

The Chinese biotechnology company, Yikon Genomics Inc., sold the kits on a now-removed website page, claiming they can be used to “confidently screen for the presence of antibodies” in the blood to detect coronavirus infections, according to City Attorney Mike Feuer.

On social media, the company touted the kits as being “FDA approved,” officials said.

But the U.S. Food and Drug Administration as of Monday had not approved any tests that can be used at home.

The company agreed to stop its widespread marketing campaign of the test kits and pull them from the market in California until they have FDA approval, according to the City Attorney’s Office.

“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 news release. “In this crisis, Angelenos’ health depends on accurate, reliable information and legitimate products that can actually help them.”

Yikon Genomics released a statement Friday saying that it is committed to complying with all state and federal laws and intends to pursue FDA approval for the marketing and sale of their test kits.

The company’s CEO, Brandon Richard Hensinger, who was named as a defendant in the complaint, told the Los Angeles Times that the company had purchased the kits from a Chinese manufacturer and was initially told by the FDA that it could market the kits without approving the authorization before the agency changed its guidance.

He told the times that after the guidance changed, the company pulled the kits offline, canceled orders, issued refunds and that no home test kits had been delivered to customers.

In L.A. County, coronavirus testing can only be done through a medical provider, at any of the county’s drive-up testing sites and at various testing sites set up by cities like Malibu.

The tests are limited to county residents who are showing symptoms of the disease, as of Monday. Priority will be given to those who are 65 and older or have underlying health conditions.

To get tested for free at the county’s sites, eligible patients must make an appointment online.

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