Monday 30th March 2015
GeneWatch UK today warned shoppers not to buy genetic tests from Superdrug online or from their high street stores. The tests are provided by Google-funded gene test company 23andMe (1)."23andMe's gene tests are banned in the United States because the evidence for the health claims that they make has not been confirmed" said Dr Helen Wallace, Director of GeneWatch UK "Superdrug is acting irresponsibly by selling unregulated gene tests with no medical involvement".
23andMe is currently banned from selling health related genetic tests in the United States, as the company was unable to provide convincing scientific evidence to back up its health-related claims (2). In the UK, only the safety of the tube used to collect people's DNA (which holds a sample of the person's spit) and laboratory quality assurance are currently regulated. This means that there is no independent check of the claims a company makes about an individual's genetic risk of developing diseases.
Before the US ban, one US journalist found three different commercial companies made different claims about the same person's genetic risks (3). A report in Germany has since identified an individual who was wrongly diagnosed by 23andMe with a life-threatening disorder (4). A number of 23andMe's customers in the USA have also reported adverse effects on their families after finding hidden family relationships (5).
A new draft EU law which would require companies to provide scientific evidence for claims, and restrict or ban sales of genetic tests directly to consumers is still under negotiation between EU member states (6). This means there is currently no regulation in the UK to prevent consumers being misled about their health by commercial gene test companies.
"Superdrug have jumped the gun by selling tests before new gene test regulation has been finalised" said Dr Wallace "Once proper regulation has been introduced, some or all of the genetic tests they are now selling will be withdrawn from the market, due to poor science or lack of medical involvement".
In the UK, people are acting unlawfully if they send samples for genetic testing that are not their own (7). Ethicists have also warned that it is unethical to use genetic tests on children that are not required for their medical treatment.
For further information contact:
Dr Helen Wallace, 01298-24300 (office), 07903-311584 (mobile)
Notes for Editors
(1) http://www.superdrug.com/b/23andMe
(2) How FDA and 23andMe Dance Around Evidence That Is Not There. The Huffington Post. 27th January 2014. http://www.huffingtonpost.com/cecile-janssens/post_6753_b_4671077.html
(3) I Had My DNA Picture Taken, With Varying Results. New York Times. 30th December 2013. http://www.nytimes.com/2013/12/31/science/i-had-my-dna-picture-taken-with-varying-results.html?pagewanted=1&_r=3&hp&
(4) Online DNA tests: Are they accurate? Deutsche Welle. 19th January 2015. http://www.dw.de/online-dna-tests-are-they-accurate/av-18201183
(5) Genetic testing brings families together and sometimes tears them apart. Vox. 9th September 2014. http://www.vox.com/2014/9/9/6107039/23andme-ancestry-dna-testing
(6) The In Vitro Diagnostics (IVD) Regulation passed first reading in the European Parliament in 2014 and is currently under negotiation at the Council, representing member states. The draft would require companies to provide evidence of the clinical validity of their genetic tests (i.e. evidence that claims about health risks are correct) and would require medical oversight of testing.
(7) The Human Tissue Act 2004.