August 1, 2012

Connie K. Ho for redOrbit.com Your Universe Online

23andMe, a company focused on personal genetics, recently took the first step in working towards Food and Drug Administration (FDA) clearance; the FDA plans to review the paperwork over the next few months.

Previously, the Silicon Valley company refrained from government regulation, claiming that the service provided consumers with information rather than a medical service. CBS News reported that 23andMe submitted the first group of seven health-related tests for the FDA to review. By the end of next year, the organization will have submitted another 100 tests to the agency. With these exams, the organization hopes to obtain government approval and scientific credibility.

23andMe has pioneered the direct-to-consumer genetic testing industry and we are committed to helping individuals understand their own genetic information through proven DNA analysis technologies and web-based interactive tools, commented Anne Wojcicki, 23andMe CEO and Co-Founder, in a prepared statement. 23andMe is working proactively with the FDA to ensure the industry delivers high quality information that consumers can trust.

23andMes Personal Genome Service allows individuals to learn more about their personal DNA, offering over 200 health and trait reports along with information on genetic ancestry. The company believes that the service helps scientists better understand how genetics plays into health and diseases. The test makers looked at genetic code, which could possibly help doctors determine if patients have treatable health problems. For individuals, the service will help them make decisions with their healthcare provider.

I think weve now entered an era where these direct-to-consumer offerings are beginning to have real medical relevance, and therefore I am in favor of them being done within some regulatory context, said Dr. James Evans, a professor of genetics and medicine at the University of North Carolina Medical School, told National Public Radio (NPR).

The DNA samples are processed by a CLIA-certified laboratory and 23andMe hopes that the filing with the FDA will make their product fluid and transparent for the public.

23andMe has always valued the guidance of the FDA and, in fact, engaged the agency in conversations prior to launching the Personal Genome Service in 2007. Our ongoing conversations with the FDA in the last year, in particular, resulted in a focused approach that resulted in our ability to compile a comprehensive analysis of 23andMes direct-to-consumer testing for FDA consideration, noted Ashley Gould, 23andMe VP Corporate Development and Chief Legal Officer, in the statement.

According to NPR, if approved, the personalized DNA test by the genetic test maker could possibly increase acceptance of a technology that is questionable to various scientists. The saliva-based kits do not completely help explain the biology of DNA variations related to certain disease. A bulk of geneticists believes that the tests are not reliable.

Read the rest here:
23andMe Genetic Testing Company Applies For FDA Approval

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