Out of Regulatory Limbo, 23andMe Resumes Some Health Tests And Hopes To Offer More

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Publish Date:
October 27, 2015
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Nature
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Summary

Professor Hank Greely comments on the changes that 23andMe has undergone after being shut down temporarily for Nature.

As DNA-testing firm 23andMe resumes selling health-related services in the wake of a regulatory shutdown, the company says that it remains committed to its original business plan of providing genetic information directly to consumers. It plans to work with the US Food and Drug Administration (FDA) to expand its offerings.

On 21 October, 23andMe rolled out a US$199 test that can show whether a person carries genes associated with 36 different disorders, such as cystic fibrosis and β-thalassaemia. Before the FDA shut down its health business in November 2013, the company had offered consumers genetic testing to estimate their risk for 240 health conditions, such as breast cancer and heart disease, for $99. During the nearly two-year ban, 23andMe continued to provide consumers with information about non-medical traits such as ancestry.

“They are relaunching with one-quarter of their initial tests, including precisely none involving the customer’s personal health situation, and they are charging twice as much,” says Hank Greely, lawyer and bioethicist at Stanford Law School in California.

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