Original URL: http://www.theregister.co.uk/2008/04/21/personal_genetics_regulation/

US watchdogs threaten vanity gene testers

Crack down on DNA crackers

By Christopher Williams

Posted in Science, 21st April 2008 13:19 GMT

The new market in personal genetics, Silicon Valley venture capitalists' latest great hope, is facing regulatory scrutiny from authorities concerned about a "wild west" approach to extremely sensitive information.

About a dozen young companies, including 23andme, the startup backed by Google (and founded by Sergey Brin's wife), purport to offer insight into their customers' risk of developing various conditions by testing for gene variants. A simple cheek scrape or saliva sample is all that's required to tell you great things about your genetic inheritance and medical future, or so the marketing goes.

However, companies offering diagnostic services are tightly controlled in many states, and New York's Department of Health has written to several personal genetics firms threatening legal action. The department insists they must have a permit to test New York residents.

23andme is trying to avoid regulation by claiming its tests are not about disease. A spokesman told Forbes: "23andMe's services are not medical... they are educational."

"Frankly, it blows my mind that someone would be saying that looking at whether you are going to get multiple sclerosis is recreational," replied a New York official. He said 23andme will be referred to prosecutors if it continues to violate the law.

California is also investigating 12 complaints against unnamed personal genetics outfits. State law there says all genetic tests must be ordered by a licensed doctor.

23andme's website does not make any medical claims, but the report received by consumers who cough the $1,000 fee includes data on genes associated with heart disease, various cancers, and bowel disorders.

One worry is that the screening offered by personal genetics companies are by no means comprehensive. As well as filling doctors' offices with even more of the "worried well", the pick-n-mix approach adopted by personal genetics firms could mean those with a family history of cancer are misled into believing they have escaped inheriting a deadly gene.

It seems regulators are slowly waking up to the new questions posed by the collision of the web, data harvesting, and cheap biotechnology.

Last week, two prominent doctors called for laws to tackle Google and Microsoft's ongoing landgrab in the US patient records market. ®