08 December 2014
ByAppeared in BioNews 783
The launch comes after the UK regulator, the Medicines and Healthcare Regulatory Agency (MHRA), approved the test kit after testing to ensure certain minimum safety standards were met. The MHRA did not test the reliability of the genome testing service as this is beyond their remit.
Sold at a cost of £125 per person, the service uses information obtained from DNA analysis of a saliva sample to estimate a person's genetic risk for ovarian and breast cancer, Alzheimer's disease, and other traits like baldness. It also claims to provide information on ancestry, with the company saying that customers could 'discover and communicate with new relatives as part of 23andMe's DNA Relatives feature'.
Anne Wojcicki, CEO and co-founder of 23andMe, told The Telegraph the company aims to 'fundamentally change the healthcare system' by putting health risk information directly in people's hands. In a statement, she added that 23andMe's service would 'ensure individuals can personally access, understand and benefit from the human genome'.
A UK Department of Health (DH) spokesperson told The Telegraph that 'initiatives that help to raise awareness of genomics and those which enable people to take more interest in their personal health' were welcome. The spokesperson nonetheless urged people 'to think carefully before using private genomic services as no test is 100 percent reliable'.
In 2013, the US Food and Drug Administration banned the company from marketing some of its health-related services for failing to provide evidence on the reliability of its results (see BioNews 733). Of particular concern were tests that analysed customers' DNA for gene variants linked to life-threatening diseases and drug responses.
At the time, the FDA noted that the company's services could mislead customers into making life-changing health decisions based on imprecise results. For example, low risk results could give false reassurance to customers, preventing them from seeking treatment on time.
BBC News reported the DH's assertion that 23andMe's UK offering would be different from that banned in the USA. According to the spokesperson, 'many of the drug responses, inherited conditions and genetic health risks that were of concern in the US have been removed'.
A statement from the company, however, notes that while the tailored health report is not intended to be diagnostic, it includes 'results for genes associated with certain inherited conditions such as cystic fibrosis or sickle cell anaemia'.
The service will also test 'for genes that may reveal risk factors for certain diseases or conditions such as blood clotting, Alzheimer's disease or Parkinson's disease, and how your body may respond to specific medications, such as warfarin or Hepatitis C treatments'.
The Alzheimer's Society issued a sceptical statement, advising: 'If you are worried about your memory, your GP should be the first port of call - not a home DNA testing kit.'
The Society added that while 'research has identified a number of genes that may play a role in the development of dementia' available evidence was not conclusive enough to 'use such data as a diagnostic tool'.