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Personal-genetics company seeks regulatory approval

Personal-genetics company 23andMe announced Monday that it was seeking approval from the US Food and Drug Administration (FDA) for an initial batch of seven health-related tests, with scores more to follow.

23andMe, based in Mountain View, California, markets genetics testing straight to consumers. For about US$300, customers can mail in a saliva sample and then see an overview of their genetic variants online, along with information about how their variants have been implicated in health and disease.

Ashley Gould, vice-president of corporate development at 23andMe, told Nature that oversight by the FDA would increase confidence in genetic testing.

In the past, 23andMe has maintained that regulation was not necessary, arguing that the genetic analysis provides information, not a medical service. Gould told Nature that the company is now pursuing approval for tests covering subjects such as disease risk and drug response.  The FDA will not be considering tests for non-medical information such as ancestry, or traits such as eye or hair colour.

Gould also says that 23andMe will provide more customers information about more genetic variants as data arise in the scientific literature. “We are hopeful that the existing regulatory framework is flexible enough to accommodate the dynamic nature of genetic science while protecting individual access,” she says.

Increasing popularity of direct-to-consumer testing has raised concerns that findings are not robust or straightforward, and that individuals would have trouble interpreting results. The tests — which are offered by companies including 23andMe; Navigenics, based in San Francisco, California; and Pathway Genomics, based in San Diego, California — scan genomes for known genetic variants.

A report released earlier this month by two scientific societies in Europe found that direct-to-consumer genetic testing has “little clinical value” and explicitly discouraged testing for ‘nutrigenomics’ and for individuals who already have symptoms or known increased risk of disease. It also said that the quality of genetic testing had to include not just consistent laboratory performance but also the interpretation of results and appropriate counseling about disease risk.

Last year, the Genomics Law Report detailed how several personal genetics companies had responded after receiving letters from the FDA that their services might need to be regulated as clinical tests. For example, some companies decided not to tell customers about certain genetic variants related to drug response or serious, untreatable diseases.

In contrast, 23andMe has increased its emphasis on disease. It recently filed a patent for its discovery of a genetic marker in Parkinson’s disease and also acquired community patient website CureTogether, a social-media platform that allows patients to describe their experiences with disease and treatments. Now it appears to be the first of the direct-to-consumer companies to seek FDA approval for direct-to-consumer genetics tests.

23andMe should have a response from the FDA before the end of September.

Additional reporting by Ewen Callaway.


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