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Genetic testing – poor principles leave consumers exposed

Gene testing

Genetic testing has great potential to improve the early detection of truly horrible diseases. But the recent principles set to protect consumers from useless tests aren’t worth the paper they’re printed on.

Over the past 10 years the identification of genes associated with particular diseases has become a bit of a gold rush, leading companies to sell genetic tests that claim to predict the likeliness of developing a disease.

But there are currently very few gene/disease associations simple enough for scientists to make reliable predictions. Tests that do offer a medically ‘useful’ prediction are freely available through the NHS, accompanied by an excellent support network.

Companies out to make profits from genetic tests

Recognising the money to be made from exploiting consumer’s interests in their genes, companies, such as 23andMe and Navigenics, also offer genetic tests.

The key difference between the NHS and these companies is not just the exchange of cash, but also the actual usefulness of the tests on offer. Many of them offer little more than a fortune teller’s guess at the chances of developing a disease.

So how can they get away with selling these tests? Well, current European and UK regulations don’t require the companies to demonstrate that genetic tests are medically useful.

Gene Genie, your system’s a mess

In the face of this regulatory black hole, the Human Genetics Commission (the government’s key advisory body on human genetics) last week published a set of Principles designed to act as a code of practice to the companies selling genetic tests direct-to-consumers.

These Principles aimed to improve this market for consumers and included guidance over what tests should be sold, the need for clear information on what the tests can do, advice on what to expect from their results and proof of gene/disease associations.

We believe that these Principles fall well short of their purpose and on the rare occasion when companies offer tests with some credibility (such as those available freely on the NHS) we have serious concerns over whether these should be offered to consumers directly at all.

Who should offer predictive genetic tests?

These tests should only be available to consumers through medical professionals who can ensure that the patient fully understands the implications of the results and can offer guidance on further courses of treatment.

And worse, the lack of any form of enforcement body to ensure these companies actually adhere to these Principles, means that they’re completely meaningless.

We’re not calling for excessive regulation of a fledgling industry, and we believe that if consumers want access to information contained in their genes they have every right to do so. But it must be ensured by industry. And if this fails, through statutory regulations, where:

  • Consumers are well informed prior to consenting to testing;
  • Companies act responsibly and transparently;
  • And only medical professionals offer predictive tests for serious genetic disorders.

Genetic test or horoscope? Without better consumer protection, there’s no way of knowing.

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