Consumer genetics firm 23andMe seeks regulatory approval for disease risk tests

23andMe, a US-based personal genomics company, has sought regulatory
approval from the Food and Drug Administration (FDA) for seven of its genetic tests.

The tests, which 23andMe does not specify, are just some of
the 200 or more genetic tests for common diseases, conditions and drug responses
offered as part of the company's Personal Genome Service, which currently
retails at US$299.

Over the next six months, the company plans to submit
another 100 tests for review.

'23andMe is working proactively with the FDA to ensure the
industry delivers high quality information that consumers can trust',
co-founder Anne Wojcicki said in a statement on the company's website.

The application, made under the least stringent of the two
types of medical device review, will assess 23andMe's processes for analysing
and interpreting genetic test results.

The FDA will check that 23andMe delivers on its medical
claims and that it provides the public with access to safe and effective
medical devices. The process of review and obtaining clearance is expected to
take several months.

Most of the tests approved by the FDA are for a single
disease and give a one-off result. Not only does 23andMe test for multiple
conditions, the results of genetic testing are continuously updated as more
results from genome-wide association studies are published 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', Ashley Gould, Chief Business Officer at 23andMe
told Nature.

Until now, 23andMe has avoided government regulation by
arguing that it provides an informational, not a medical service.

'It's the next step for us to work with the FDA and actually
say, "this is clinically relevant information and consumers should work
with their physicians on what to do with it"', Wojcicki told CBC News.

'FDA clearance is an important step on the path towards
getting genetic information integrated with routine medical care', she said.

23andMe's genetic testing service, along with other personal
genome companies, has already attracted scrutiny from groups including the US
Government Accountability Office and the European Academies Science Advisory
Council for offering tests that have little clinical value.

However, several accounts are emerging where doctors have
been able to use data obtained from companies, such as 23andMe, to identify
patients with a higher risk of treatable health problems, such as response to
the drug Clopidogrel or colon cancer.

James Evans, professor of genetics and medicine at the
University of North Carolina, said much of the
information reported by 23andMe is 'relatively useless' and 'in the realm of
entertainment', but that in some cases the findings of direct-to-consumer tests
can assist doctors to identify certain conditions.

'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 favour of them being done within some
regulatory context', he said. 

Dr Eric Lander, president and director of the Broad
Institute of MIT and Harvard, agreed: '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'.

'I think 23andMe is taking a very forward-leaning step'.

This year has seen 23andMe increase its emphasis on health
and disease. Earlier this year it filed a patent for its discovery of a genetic marker in Parkinson's disease. It also recently acquired CureTogether, a
website which brings patients together to describe their experiences with
disease and treatments.