The Food and Drug Administration has ordered that 23andMe to stop sales of its genetic tests.
The company, backed by Google, has reportedly not received regulatory clearance on its genetic tests, Reuters reports.
The company was founded in 2006 by Google co-founder Sergey Brin's separated wife Anne Wojcicki. 23andMe sells a $99 DNA test that supposedly can inform you about health risks and possible genetic mutations. The FDA sent a letter on Nov. 22 that stated that "as FDA has explained to you on numerous occasions," medical devices that are supposed to help diagnose or prevent diseases need clearance.
23andMe said they had received the letter and that "we recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission."
According to Bloomberg, one of the products is called the Saliva Collection Kit and Personal Genome Service(PGS), which looks at how users would respond to a drug or more.
In a statement the FDA said, "FDA is concerned about the public health consequences of inaccurate results from the PGS device. The main purpose of compliance with FDA's regulatory requirements is to ensure that the tests work."
image: Wikimedia Commons
