Google’s co-founder Sergey Brin‘s mother has a mutation in LRRK2 gene and has Parkinson’s disease. A genetic test showed that Sergey has the same mutation.
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New York Times article
F.D.A. Faults Companies on Unapproved Genetic Tests
Published: June 11, 2010
The Food and Drug Administration is cracking down on 23andMe and other companies that sell genetic tests directly to consumers.
The F.D.A. sent letters this week to five companies involved in that business, saying their tests are medical devices that must receive regulatory approval before they can be marketed.
“Premarket review allows for an independent and unbiased assessment of a diagnostic test’s ability to generate test results that can reliably be used to support good health care decisions,” Alberto Gutierrez, who leads diagnostic test regulation at the F.D.A., wrote in the letters.
The letters, posted on the F.D.A. Web site on Friday, say the companies must apply for approval or discuss with the agency why certain test claims do not require such approval.
But the letters stop short of saying the tests must be taken off the market until they are approved. Dr. Gutierrez said in an interview that it would be unfair to remove the tests from the market because the agency had not clearly told the companies that the devices needed approval.
23andMe and two other recipients of the letters, Navigenics and DeCode Genetics, sell tests that scan a person’s DNA, looking at genetic variations that can suggest whether a person is at a higher or lower risk of getting diseases like cancer or diabetes. The most prominent of the companies, 23andMe, is backed by Google and run by Anne Wojcicki, the wife of Google’s co-founder, Sergey Brin.
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