GeneWatch UK PR: Consumers warned not to buy unregulated gene tests online

2nd December 2014 

Consumers warned not to buy unregulated gene tests online

GeneWatch UK today warned members of the public that they could be misled about their health if they buy gene tests online. US company 23andMe, which is part-funded by Google, is understood to be launching its gene test service in the UK this week.

"Genes are poor predictors of most diseases in most people and gene tests are not regulated in Britain" said Dr Helen Wallace, Director of GeneWatch UK. "There is no independent check of the claims about people's future health made by commercial companies. We strongly advise people not to take any health-related gene tests unless advised to do so by their doctor in the NHS. Most health claims made by online commercial companies will be useless or misleading". 

In the USA, the Food and Drug Administration (FDA) has banned 23andMe from selling health-related gene tests because it was not able to supply the regulator with sufficient evidence that the claims it makes about people's future health are valid (1). Other US companies have been forced to settle claims about the marketing of nutritional supplements and a skincare product that were purportedly customized to each consumer's unique genetic profile (2). Although tests for some single gene diseases and rare familial forms of common diseases can be useful, these require knowledge of family history and support from medical professionals. Tests which claim to predict risks of common diseases such as most cancers, heart disease, psychiatric diseases or diabetes in the general population are notoriously unreliable. The likelihood of developing most big killer diseases depends on hundreds or thousands of biological factors and is strongly influenced by lifestyle and environment.  As a result of this complexity, different gene test companies have often given contradictory claims about genetic health risks to the same customer, based on different computer-based calculations (3).

"Unregulated genetic tests will lead to misleading health claims and dubious marketing of drugs and other products to people wrongly told they are at risk" said Dr Wallace. "New gene test regulations are being finalised in Europe and companies should wait until these rules are in place, rather than seeking to undermine them". 

Although the FDA has stepped in to ban online sales of gene tests in the USA, regulation in Europe is still under development and there is no independent check of the claims a company makes about a person's future health (4). Thus Britain is becoming a target for marketing of tests that are banned from sale in the USA (5).

GeneWatch UK also warned that sharing DNA and genetic information with commercial companies risks loss of privacy and misuse of data. 

"Your DNA is your genetic fingerprint and can also be used to identify your relatives" said Dr Wallace. "People should think very carefully about the implications for them and their families before sending off a sample".

A number of 23andMe's customers in the USA have reported adverse effects on their families after finding hidden family relationships (6). 

For further information contact:

Dr Helen Wallace: 01298-2430001298-24300 (office); 07903-31158407903-311584 (mobile). 01298-2430007903-311584

Notes for Editors:

(1) How FDA and 23andMe Dance Around Evidence That Is Not There. The Huffington Post. 27th January 2014.

(2) Nutritional supplement marketers to drop misleading disease claims. Consumer Affairs, 1st July 2014.

(3) I Had My DNA Picture Taken, With Varying Results. New York Times. 30th December 2013.

(4) Draft regulations are part of the new EU In-Vitro Diagnostics (IVD) Regulation, which covers genetic tests and computer algorithms used to calculate a person's future risk of disease. This draft legislation is currently being negotiated between the European Parliament and Council. It includes proposals to require evidence to demonstrate the validity of predictions made about a person's health and to prevent direct-to-consumer sales of gene tests without the involvement of a medical professional.

(5) The FDA won't let 23andMe test your genes - so it may go to Europe. Vox. 12th May 2014.

(6) Genetic testing brings families together and sometimes tears them apart. Vox. 9th September 2014.

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