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The US Just Greenlit the First Consumer DNA Tests for Disease Risk

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Rosalie Lee
Apr 07, 2017 02:25
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In many cases, we just don’t know enough about a gene to say what it means for our health.

For this reason, the US Food and Drug Administration has sought to protect consumers by preventing DNA testing companies from telling them whether or not they’re are at risk for a certain disease.

On Thursday, for the first time ever, the FDA gave a DNA testing giant—23andMe—the green light to market tests for 10 diseases or conditions directly to consumers, without the involvement of a doctor.

That includes tests for Parkinson’s disease, late-onset Alzheimer’s and coeliac disease.

Originally, 23andMe offered assessments for more than 250 diseases and conditions, but in 2013 the FDA cracked down, ordering the company to cease providing analyses of people’s risk factors for disease until the tests’ accuracy could be validated.

Where it once reported “health risks” along with specific tips and guidance on how to reduce them, for the last few years it has only been allowed to report whether or not a person has “carrier status” for a disease.

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Rosalie Lee
Apr 07, 2017 02:25
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