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23andme cleared by FDA to offer genetic health risk tests

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By Joy Johnston, Cox Media Group National Content Desk

The Food and Drug Administration has authorized 23andme, a personal genomics company, to offer disease-risk predicting tests directly to consumers without a prescription.

The approval comes after a lengthy battle that began in 2013 when the FDA forced 23andme to remove all 254 of its genetic health risk tests from the market, according to Forbes. 23andme uses a consumer’s saliva sample to run genetic tests.

Since that 2013 ruling, genetic testing results have appeared in respected medical journals, and the concept of genomic risk is more accepted by the scientific community. Critics caution that consumers may take the results too literally, instead of as one piece of their health puzzle, and undergo unnecessary tests or procedures.

The new FDA ruling allows 23andme to provide 10 genetic health risk tests for conditions ranging from late-onset Alzheimer’s disease to celiac disease. The ruling also grants an exemption which could approve further genetic risk tests by 23andme more quickly.

“The FDA has embraced innovation and has empowered people by authorizing direct access to this information,” said 23andMe co-founder and CEO Anne Wojcicki in a company press release.

The new tests will begin to roll out this month and will be available to new customers immediately. Current customers will be notified of test availability.

 

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