US FDA bans 23andme direct to consumer genetic testing kit

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The Food and Drug Administration, USA has ordered 23andme – the maker of a popular genetic-testing kit to stop sales of its heavily marketed product, saying the mail-order tests haven’t been proven effective and could dangerously mislead people about their health.

23andMe sys regarding FDA Warning Letter : We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.

The company 23andme says that its Personal Genome Service can detect more than 240 genetic conditions and traits, flagging a person’s vulnerability to heart disease, breast cancer and other illnesses. The privately held company, founded in 2006, is headed by biologist and businesswoman Anne Wojcicki, who is separated from Google co-founder Sergey Brin.

The FDA said the company repeatedly has failed to provide the scientific data necessary to prove that its test works as advertised.

In its letter, which was dated Nov. 22 but posted online Monday, the FDA said it was concerned about 23andMe’s direct-to-consumer test “because of the potential health consequences that could result from false positive or false negative assessments,” which could lead people into unnecessary or ineffective treatments. The agency also said that the company had failed to support its claims despite “more than 14 face-to-face and teleconference meetings” with FDA officials, as well as “hundreds of e-mail exchanges” and “ample detailed feedback.”

“Since July of 2009, we have been diligently working to help you comply with regulatory requirements,” the FDA said. “However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the [test] for its intended uses.”

Source: U.S. Food and Drug Administration, USA

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