Genetic test manufacturers to 23andMe, United States food and drug administration, personalized DNA test to approve a motion to increase the acceptance of technology displayed by leading scientists who are skeptical if the success that its usefulness is looking for the question.
23andMe suckling allows consumer to peek for more information about the health and future of their ancestors in the genetic code, is part of the industry. Saliva-based Kit for the company attracts the claims scrutiny can detect likely to develop diseases of breast cancer, heart disease, Alzheimer's disease like users they are.
23andMe co-founder Anne show clinically relevant information for the consumer provides genetic testing kits step seen here Wojcicki 2008 company following the FDA says. (Reuters Fred Prouser /)Such testing is built on flimsy evidence many geneticists and biology is still poorly understood how certain diseases actually DNA variations that lead to say.
Information and not medical services simply claims, Silicon Valley companies but has resisted the consumer provision of government regulation. Say company executives are looking for Government approval — and scientific reliability with it.
"Next step is FDA and work, to actually say ' this is clinically relevant information consumers should tackle something with their doctor '" and Ann Wojcicki, Google co-founder Sergey Brin were married co-founder and CEO. Has invested millions in the privately held company is based on Google and Brin mountain view, California.
To reflect the shift in strategy for growth range of 115 different diseases development risk company test kit Wojcicki now over and are referred to as.
23andMe, 7 health-related tests, the FDA reviews the initial batch sent Monday said. The company in another test of 100 additional installments, to submit by the end of the year plan. Not applicable under the supervision of the FDA, so no verification, tests, including family history and medical traits.
Says harsh criticism of some genetic testing industry is taking the right approach to 23andMe.
He 23andMe is "relatively useless" ", realm of entertainment" by he believes many of the information reported, said Dr. James Evans North Carolina University benefit from patients more to pursue the analysis of potential risks in the development of various diseases than healthy lifestyle believe.
Start the test maker to analyze the genetic code of the larger part of the rare may help doctors identify patients with a high risk of health problems, including findings and aneurysm or colon cancer treatment.
"We are now starting directly the product of actual medical related to these consumers so I entered the lucrative period occurring in the regulatory context some of those thinking" in Evans, genetics and UNC Medical University medical professor said.
Navigenics and 23andMe, competitiveness, decode genetics are competitors such as test market can be moved. Comment did not respond Monday to these companies.
"We take the leadership in this industry really wants to" and said 23andMe Chief Counsel Ashley Gould. Test more than 150000 people around the world is $ 299 online selling used is called that.
FDA controls managed by the health care provider, such as one given already to detect various pregnant woman to fetus in cystic fibrosis genetic testing.
However, it remains to see whether it supports a 23andMe sidesteps the commercial approach doctors FDA results directly to consumers by sending a. We believe that peer and personal genetic information mainstream market is it is still a niche field.
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