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Personalized DNA test, 23andMe, seeks FDA approval


Linda Avey and Chevy Chase attend the 23 and Me Spit party at the IAC Building on September 9, 2008 in New York City.


Donald Bowers

Personalized DNA test company 23andMe seeks Food and Drug Administration approval.

The Silicon Valley-based company has created a way for customers to look at their genetic code to better understand their ancestry and future health.

"It's the next step for us to work with the FDA and actually say, 'this is clinically relevant information and consumers should work with their physicians on what to do with it,'" said co-founder and CEO Anne Wojcicki, reported CBS News.

According to Discover Magazine, the company uses saliva kits to see if users are susceptible to certain diseases such as cancer.

Yet, detractors say that DNA variations are still little understood and that the tests are created without enough research as to their reliability.

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23andMe has, until now, avoided government scrutiny and regulation, saying that it is not providing a medical service but rather just information.

This, despite FDA letters to the company in 2010 urging them to submit their products to the government body for review, reported the San Francisco Chronicle.

The FDA has also banned companies from selling the kits in drug stores.

The company was named for the 23 pairs of chromosomes in the human body.

It is reported that co-founder Wojcicki is married to Google co-founder, Sergey Brin, who has invested millions in the company.