SAN FRANCISCO (KPIX 5) – The Food and Drug Administration has ordered Google-backed genetic test maker 23andMe to halt sales of its personalized DNA test kits, saying the company has failed to show that the technology is supported by science.
The privately-owned personal genomics and biotechnology company, located in Silicon Valley, sells direct to consumer saliva testing kits.
Within a few weeks of mailing in your sample, customers get more than 250 reports on DNA, from the risk of disease to ancestry.
“We want you to have the best information about what your DNA means for you,” says Anne Wojcicki of 23andMe.
Now the FDA has accused the company of violating federal law. In a scathing 3-page letter, the agency says the company “failed to provide” proof its DNA tests are safe or effective despite extensive communication with the FDA since 2009.
U.S. Regulators have ordered 23andMe to stop selling the test for now, or face consequences that could lead to shutdown.
The biotech has already provided results to more than half a million customers. Sales have been strong since the company dropped the test price to just $99.
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