A personal DNA test that has sparked controversy in the US has launched in the UK, BBC Health News reports.
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) says the 23andMe spit test, which is designed to give details about a person’s health risks based on their DNA, can be used with caution. But critics say it may not be accurate enough to base health decisions on. The company, California-based 23andMe, stands by its test. Backed by Google, the firm offered US customers details of health risks based on gene variants they carry. But in November 2013, the US Food and Drug Administration (FDA) banned the company from marketing its service in the US, claiming 23andMe had failed to provide adequate information to support the claims it made about results.
A month later, the company stopped offering genetic tests related to health. An MHRA spokesperson said it regulated such tests in the UK to make sure they met minimum standards.
The UK Department of Health said it was behind the idea of using gene tests to guide patient care within the NHS, but echoed the MHRA advice on giving careful consideration before opting for services like the one offered by 23andMe. The Alzheimer’s Society went a step further saying: “‘If you are worried about your memory, your GP should be the first port of call – not a home DNA testing kit. Research has identified a number of genes that may play a role in the development of dementia but we don’t know enough to use these as a diagnostic tool.”
23andMe chief executive Anne Wojcicki said: “The UK is a world leader in genomics and we are very excited to offer a product specifically for UK customers.”
The company had previously offered results on a customer’s risk for 254 diseases and conditions, including identifying genes linked to heart disease and breast cancer. There was also information on how individuals might respond to certain medicines. But the FDA said the reliability of such tests had not been proven to its satisfaction. It was also worried that some customers could make life-changing decisions based solely on their results.
The UK Department of Health said the product launched in Britain was very different to the service halted by the US regulator. “Many of the drug responses, inherited conditions and genetic health risks that were of concern in the US have been removed,” a spokesperson told BBC News.
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