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Should Google-backed disease detector be allowed in UK?

23andMe allowed to sell DNA disease detection kit in UK, despite US clampdown

A controversial, Google-backed service which promises to reveal your risk of getting inherited diseases has gone on sale in the UK – despite falling foul of medical authorities in the US. For the sum of £125, 23andMe promises to reveal inherited conditions and other genetic risk factors to users who post the company a sample of their saliva using a provided kit.

The 23andMe website says the DNA sample will allow customers to “learn if you are a carrier for certain inherited conditions” and “understand how your DNA may affect your health”, offering a risk assessment for conditions such as Alzheimer’s, Parkinson’s Disease and Cystic Fibrosis. However, the website also claims its “reports are intended for informational purposes only and do not diagnose disease or illness”. 

This so-called Personal Genome Service (PGS) has incurred the wrath of US regulators. The US Food and Drug Administration (FDA)  rebuked the company in 2013 for potentially giving customers misleading information about their health. “Some of the uses for which PGS is intended are particularly concerning, such as assessments for BRCA-related genetic risk and drug responses (e.g. warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these,” the FDA stated.

For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognise an actual risk that may exist.”

23andMe eventually came to an agreement with the FDA to remove health reports, and concentrate purely on providing raw genetic data and ancestry information. It has subsquently reapplied to provide information on selected health conditions, but has yet to win approval.

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) appears to have a more relaxed attitude to 23andMe’s services. A spokesman told the BBC that: “People who use these products should ensure that they are CE marked and remember that no test is 100% reliable so think carefully before using personal genome services. If after using the service, you have any questions or concerns you should speak to your healthcare professional.”

23andMe is run by Anne Wojcicki, the estranged wife of Google co-founder Sergey Brin. Google invested $3.9 million in the company in 2009. 

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