FDA OKs Marketing of DTC Genetic Health-Risk Tests

23andMe customers can now receive information about genetic risk for diseases including Parkinson’s and celiac.

Written byDiana Kwon

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The US Food and Drug Administration (FDA) has granted the personal genomics company 23andMe authorization to market direct-to-consumer (DTC) tests that provide information about a person’s genetic risk for 10 conditions, including late-onset Alzheimer’s disease, celiac disease, and hereditary thrombophilia. This authorization, announced yesterday (April 6), does not extend to diagnostic tests associated with potentially preventative action, such as those for BRCA genes.

The FDA emphasized that while results from these tests may help inform customers’ lifestyle choices or conversations with medical professionals, the results should not be considered a diagnosis or be used to inform treatment decisions. The agency also noted the risk for false-positive and false-negative findings.

“Consumers can now have direct access to certain genetic risk information,” Jeffrey Shuren, director of the ...

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Meet the Author

Diana Kwon
Diana is a freelance science journalist who covers the life sciences, health, and academic life. She’s a regular contributor to The Scientist and her work has appeared in several other publications, including Scientific American, Knowable, and Quanta. Diana was a former intern at The Scientist and she holds a master’s degree in neuroscience from McGill University. She’s currently based in Berlin, Germany.
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