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The move may also give 23andMe a competitive edge over rivals like deCODE Genetics and Navigenics, which market similar tests. Those companies did not respond to requests for comment Monday. "We really want to take a leadership role in this industry," said 23andMe's chief legal officer, Ashley Gould. The company says more than 150,000 people worldwide have used its test, which sells for $299 online. The FDA already regulates a variety of genetic tests administered by health care providers, such as those given to pregnant women to detect cystic fibrosis in a developing fetus. But it remains to be seen whether the FDA will endorse 23andMe's commercial approach, which sidesteps doctors by sending results directly to consumers. 23andMe and its peers believe there is a mainstream market for personalized genetic information, though it is still very much a niche field. 23andMe executives point out that they first contacted the FDA in 2007, before launching their product. The agency did not take an interest in the technology until 2010, when it issued letters to several testing companies, stating that their products are considered medical devices and must be approved as safe and effective.
Washington's pressure on the industry intensified a month later, when federal investigators issued a scathing report saying that companies like 23andMe produced misleading information of little to no use. An undercover investigation by the Government Accountability Office found that four genetic testing companies delivered contradictory predictions based on the same person's DNA, which often contradicted the patient's actual medical history. Proponents of genetic testing say 23andMe's bid for FDA approval is an important step in regulating an emerging application for genetic information. "Many consumers are going to want to know this information, and you don't need a hospital to obtain it, so it's important to make sure it's well regulated," said Dr. Eric Lander, president and director of the Broad Institute, a genomic research center affiliated with Harvard University and the Massachusetts Institute of Technology. "I think 23andMe is taking a very forward-leaning step."
[Associated
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