Word: 23andme
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...company charges $350,000 for whole-genome sequencing.) The services range from paternity and ancestry tests to risk assessments for specific diseases, such as breast cancer and Type 2 diabetes. Some tests look for single genes associated with disorders (baldness, in the case of HairDX); others, like 23andMe, one of the industry leaders, use a DNA chip to scan the entire genome in search of single nucleotide polymorphisms, or SNPs - genetic variants that help determine risk for disease or likely traits such as eye color...
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...