Clampdown on companies offering genetic disease testing

Government advisers step into unregulated industry amid fears customers can be misinformed
Genetic laboratory test tubes
Many companies now offer to calculate disease risks in exchange for hundreds of pounds and a sample of saliva or blood. Photograph: George Disario/Corbis

Companies which sell genetic tests for conditions such as breast cancer and Huntington's disease are facing a clampdown in a bid to stop customers being given wrong information about their health.

New rules are planned to improve standards in the booming industry, which charges people hundreds of pounds in return for calculating their risk of disease from samples of blood or saliva.

The Human Genetics Commission (HGC), which advises the government on developments in genetics, has drawn up the first set of guidelines for what is currently an unregulated private industry. A new framework will compel firms to adhere to basic principles of consent, data protection, truthful marketing and scientific rigour.

Some companies offer to test large numbers of genes and claim the results will let people stay ahead of a possible illness by, for example, getting preventative treatment.

"However, there is concern that some tests may not be precise, have little basis in science and offer false hope to consumers, while vast amounts of sensitive personal genetic information is being accumulated and stored", a Department of Health spokesman said.

Under the new regime those offering tests for potentially fatal hereditary diseases, such as Huntington's or breast cancer, should only do so if the customer is offered counselling both before and after the test, in case the result proves distressing or raises difficult issues about whether to tell others who may also be affected.

Claims made about tests should be backed by scientific evidence published in reliable journals. And customers must also be told what the possible outcomes are, for example finding out that they have an incurable disease that their siblings or offspring may have or may soon develop.

Dr Frances Finter, an HGC commissioner who chaired the international expert group which devised the new principles, said: "Some tests can cause considerable surprise or concern to those taking them – or give false reassurance. Some are of doubtful value, to say the least. We need a set of 'off the shelf' principles that can be used everywhere."

Dr Jim Wilson, a population geneticist at Edinburgh University, said the initiative was a timely move. "I welcome this action because there are cowboy companies out there and also because a lot of the predictions that are being presented to the public are akin to reading tea-leaves," he said.

Wilson said that of the large number of firms offering genetic tests, only three are in his view reputable, including US-based, which is backed by Google and claims to have 35,000 customers worldwide.

"It's hard trying to explain such complicated things to the public, like what their risk is of developing something and also how much is actually known about what our genes tell us about those risks, but my concern is that a lot of these companies don't do enough of that," he added.

"These tests are a bit of a lottery. If each person's full genetic profile equates to 25 playing cards, someone undergoing one of these tests will only get the identity of three of those 25 cards, because that's how far the science has progressed," said Wilson.

Concern has also been raised that insurance companies might ultimately use test results to deny people cover, although the Association of British Insurers has pledged not to use genetic findings until 2014.

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