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Genetic test for Alzheimer’s risk given approval for sale in US

The US Food and Drug Administration has given approval to the company 23andMe to market a spit test that assesses a person鈥檚 risk for 10 diseases

PEOPLE in the US will soon be able to buy a genetic test that tells them whether they are at risk for late-onset Alzheimer鈥檚 disease.

The saliva-based test is being marketed by 23andMe, based in California. The firm already offers 鈥渟pit kits鈥 for US-based customers who want to trace their ancestry or to know their risk of passing on genetic diseases to their children.

But in 2013, the Food and Drug Administration banned 23andMe from offering a test that assessed genetic risk for 254 diseases. The FDA was especially concerned by the test鈥檚 assessment of breast cancer risk 鈥 a false positive might encourage a person to get unnecessary surgery, while a false negative might lead someone to ignore symptoms.

The new test won鈥檛 assess breast cancer risk, but will screen for Alzheimer鈥檚, Parkinson鈥檚, coeliac disease and seven other disorders. The FDA鈥檚 approval was largely based on studies and trials that show these conditions are linked to genetics, and the fact that the test is at least 99 per cent accurate.

23andMe already markets a similar product in seven countries, including the UK.

This article appeared in print under the headline 鈥淎lzheimer鈥檚 test鈥

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