DNA home testing kit hits the UK

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9 December 2014

2-3 or not 2-3?

That is the question. Stories have surfaced in the media recently regarding the UK launch of a personal/home DNA testing kit by the US-based biotech company 23&Me. For a nominal fee, users can have their DNA analysed for some common gene sequences associated with increased risk of developing a certain disease condition or physical trait. The information will also provide some indication about the ancestry of the customer.

Although the procedure looks very simple and, at first glance secure, users should think carefully before purchasing their genetic information. US regulators (US Food and Drug Administration; FDA) have banned 23&Me from marketing the service in the United States, due to concerns that inadequate information was supplied to back up the companies’ claims that it made about results. Although the equivalent regulatory body in the UK (Medicines and Healthcare Products Regulatory Agency; MHRA) have stated a 'toned-down' version of the test can be used by UK users, they advise caution before using such personal genome services. Users should refer to the MHRA website for a fact sheet on self-testing.

Crucially, users should understand the limitations of the service, mainly that the information is by no means definitive. A person may have an increased risk due to their genetic coding, but it doesn’t mean they will necessarily develop that condition. Conversely, a negative result doesn’t mean they won’t go on to develop a disease or trait. Visitors to the 23&Me website will notice that caveats and cautions feature heavily in the site content (“may”, “more research needed” and “consult your healthcare provider” feature regularly).

Whilst we at Lab Tests Online-UK are in favour of enhancing patient knowledge and understanding of information regarding healthcare, we strongly recommend that users consider their options carefully before purchasing their genetic information. Once this genie is out of the bottle, it can’t be put back in. Were this information to fall into the wrong hands, it could have serious implications for the user e.g. insurance companies may demand higher premiums if they deem a customer to be high risk. And as mentioned above, a positive result may cause unnecessary worry while a negative result may provide false reassurance. The fact is, our understanding of disease processes is not complete; many require certain sequences in more than one gene to cause disease, and the environment, age, sex etc. also play an important role.

So does that mean you should do nothing? Not at all. If you are concerned about a certain condition due to family history, you should consult your healthcare provider who will be able to provide a more thorough and meaningful explanation and possible investigation.