Call to regulate do-it-yourself genetic testing kits rejected

  • @tompeck

The sale of do-it-yourself genetic testing kits – bought over the internet and then sent off for laboratory analysis and sold on the basis of assessing personal risk of diseases or of clearing up paternity battles – will remain unregulated despite concerns over their accuracy.

The UK's Human Genetics Commission will today publish new guidelines for the sale of "direct-to-consumer" genetic testing kits, which have surged in popularity in recent years as the technology to test for genetic susceptibility to diseases such as Huntington's and breast cancer have become more affordable.

However the new guidelines remain voluntary and carry no penalties if they are breached.

The guidelines – which state that tests for serious hereditary diseases should only be provided with the offer of counselling both before and after testing – come after controversy earlier this year in the US in which the Food and Drug Administration stepped in to regulate five leading genetic testing service providers.

One company, 23andMe, sent inaccurate information to 96 clients after a tray of samples was misplaced in a laboratory. The mistake left one client believing that her son was not her own, while another was led to understand that she was of African origin while the rest of her family is Caucasian.

The lack of governmental oversight of direct-to-consumer genetic testing has attracted outspoken criticism from scientists.

Although today's guidelines are voluntary, it is hoped that they will encourage companies to sign up to basic principles of consent, data protection and scientific rigour.

Dr Frances Flinter, the HGC Commissioner who chaired the international expert group that developed the principles, said: "Direct-to-consumer tests covering everything from hereditary illnesses to ancestry research are now available over the internet from companies in the USA and Europe.

"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. To cover this international market we need a set of 'off-the-shelf' principles that can be used everywhere."

Companies in the UK are now offering to test large numbers of genes and making claims that the tests will offer people considerable insight into future health risks.

In 2008, the HGC met with "direct-to-consumer" genetic testing providers, patient representatives and professional bodies to discuss concerns that some tests may be not be precise, have little basis in science and offer false hope to consumers, as they surrender vast amounts of sensitive personal genetic information to be accumulated and stored.

It was agreed then that a framework of principles be developed.