23andMe ordered to stop selling $99 genetic test
Date: 3.12.2013
It's a serious telling off. The US Food and Drug Administration has ordered personal genetics company 23andMe to stop marketing its popular DNA screening kit.
In a letter to the Californian company, sent on 22 November, the FDA stated concerns about the public health consequences of inaccurate results.
23andMe sells a DNA testing kit for $99, which it claims can provide customers with data on the potential effect of their genetics on their health. This includes their risk of developing 254 conditions, including diabetes and heart disease. The company states that these tests enable users to "take steps toward mitigating serious diseases".
The FDA said that after several interactions with 23andMe, including more than 14 meetings and hundreds of email exchanges, the agency still hasn't received any assurance that 23andMe has analytically or clinically validated their tests for their intended uses. The FDA is particularly concerned about the gene tests offered by 23andMe that claim to inform customers of their susceptibility to breast cancer.
If the test wrongly diagnosed a woman as susceptible, she may undergo unnecessary corrective surgery or drug treatment, and a missed diagnosis would allow cancers to develop unchecked, the FDA warned. Likewise, incorrect results for sensitivity to drugs, such as blood-thinning warfarin, could put people at risk of blood clots or other complications if they alter their medication.
