Word: 23andme
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Dates: during 2008-2008
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Meanwhile, representatives of leading companies, including 23andMe, Navigenics, deCODE Genetics and DNA Direct, have stepped into the void, launching discussions this month in Washington to devise their own voluntary standards, which they expect will promote integrity among their competitors. The companies said they will collaborate with the Personalized Medicine Coalition (PMC), an educational nonprofit, to create the guidelines. They plan to present a draft of the new rules at a PMC conference in December, says Edward Abrahams, PMC's executive director...
Indeed, even government regulators can hardly figure it out. In June, after receiving complaints from consumers, the California Department of Health sent cease-and-desist letters to 13 companies, including deCODE Genetics, 23andMe and Navigenics, asking them to stop doing business with California customers until they could prove they were complying with state laws. In California, only physicians may order lab tests, and all labs must obtain a state license and meet federal CLIA requirements. Last November, New York State's Department of Health mailed similar letters to 31 companies. (Navigenics and 23andMe have since submitted business plans...
Those questions fuel the debate over whether the information amounts to medical advice. Many doctors say it does. Most companies, including 23andMe, disagree; they say they are simply offering customers genetic information that already belongs to them. If so, how useful is that information? Again, many doctors say it's still far too early to gauge its benefit, because consumers are not capable of interpreting their genetic information or making any meaningful changes in lifestyle or health based on it. In January, Dr. Jeffrey Drazen, editor of the New England Journal of Medicine, co-authored a commentary questioning the tests...
What's more, the tests don't always offer consistent results. Linda Avey, co-founder of 23andMe, says consumers have received conflicting results from different companies. That can happen for various reasons: not all tests read the same SNPs to calculate the same risk, and not all risks are calculated using the same metric (some results compute the risk of cancer over a lifetime, for example, while others may assess the risk within a 10-year window). "We want to come together as scientists and say, Here's how we should present the information to the consumer," says Avey...
...information you receive? How accurate? The science behind these tests is still so new that some health regulators and medical professionals are questioning their validity and their practical utility. TIME.com's Sarah N. Lynch recently sat down with Linda Avey, co-founder of one of the industry's leaders, 23andMe, based in Mountain View, Calif...