August 1, 2012
23andMe Genetic Testing Company Applies For FDA Approval
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.”
23andMe´s 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 we've 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 23andMe´s 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.
“FDA clearance is an important step on the path towards getting genetic information integrated with routine medical care,” explained Wojcicki in the statement. “As the knowledge around personalized medicine continues to grow, consumers should expect their healthcare providers to begin to incorporate genetic information into their treatments and preventative care.”
Apart from looking at the genetic testing from 23andMe, the FDA already has a number of genetic tests it regulates. It´s unclear whether the FDA will accept 23andMe´s proposal as the results of the genetic tests from the service are normally sent directly to the consumers instead of the physicians. Those who advocated for genetic testing believe that the bid by 23andMe is a step in the right direction.
"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," noted Dr. Eric Lander, president and director of genomic research center Broad Institute, in the NPR article. "I think 23andMe is taking a very forward-leaning step."