DNA Test Banned In USA Now Sold In UK

Controversial Testing Kit Can Be Marketed In UK

03.12.2014

A personal DNA test that was banned from being marketed in the USA has made its way to the UK.

The spit test, made by California-based company 23andMe, is designed to provide users with information about health risks that could affect them.

It was banned by the US Food and Drug Administration in November 2013 after the authority said the company had failed to provide adequate information to support its claims about the reliability of the test.

However, the UK's Medicines and Healthcare Products Regulatory Agency says the product can be "used with caution", with the caveat that "no test is 100% reliable".

There have also been concerns raised about what the Google-sponsored company does with the data it takes from customers.

"It's not entirely clear what their business plan is - whether they want to make money by selling kits to consumers, or whether they want to make most of their money by selling consumer data to other companies," Professor Hank Greely, Director of the Centre for Law and the Biosciences at Stanford University told BBC News.

Expert Opinion
Serious concerns have been raised regarding this product and it is vital that UK regulators consider the issues raised carefully. While the Department of Health has told some media that the product launched on these shores is different to that halted by US authorities, it should be noted that the FDA in the US has not reapproved the product for sale.

"It is essential for any manufacturer to clearly emphasise the risks of using a product of this nature, including how it is only intended to cover a few genetic health conditions – so therefore users should not consider themselves free from future genetic complications.

"In addition, manufacturers should also confirm that such a product cannot be seen as a suitable alternative to a thorough genetic test in a controlled clinical environment using modern analytical equipment.

"Sensible medical advice should also be provided, with any detail stating that concerns over the risk of genetic conditions should be considered with a suitably qualified healthcare professional having regard to individual specific factors such as lifestyle and diet."
Kevin Timms, Solicitor