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Halt sales, US tells maker of DNA tests

Food and Drug Administration regulators say that the Silicon Valley company 23andMe has not shown that its personalized DNA test kits are safe or effective.23andMe/Associated Press

WASHINGTON — The Food and Drug Administration has ordered genetic test maker 23andMe, which is backed by Google, to halt sales of its personalized DNA test kits, saying the company has failed to show that the technology is supported by science.

In a warning letter posted online Monday, FDA regulators say that the Silicon Valley company has not shown that its tests are safe or effective despite ‘‘more than 14 face-to-face and teleconference meetings’’ and ‘‘hundreds of e-mail exchanges.’’ The agency ordered 23andMe to stop marketing its test immediately, warning that erroneous results could cause customers to seek unnecessary or ineffective medical care.


23andMe’s saliva-based test kit, launched about five years ago, claims to tell customers if they are at risk for more than 250 diseases and health conditions. The FDA says only medical tests that have been cleared by the government are permitted to make such claims.

The letter follows years of back-and-forth between the government and 23andMe, the most visible company among a new field of start-ups selling personal genetic information. The spread of consumer-marketed DNA tests has troubled doctors and health officials who worry that the products are built on flimsy science.

For years, 23andMe resisted government regulation, arguing that it simply provides consumers with information, not a medical service. But last year the company changed course, submitting several of the disease-specific tests included in its test kit.

A spokeswoman for the Mountain View, Calif.-based company said 23andMe recognizes it has been late in responding to FDA questions about the application.

The FDA warning, dated Nov. 22, takes issue with a number of claims the company makes for its test kit, particularly calling it a ‘‘first step in prevention’’ against such diseases as diabetes, heart disease, and breast cancer. Regulators worry that false results from the test could cause patients to receive inadequate or inappropriate medical care.


23andMe was cofounded by Anne Wojcicki, who recently separated from her husband, Google cofounder Sergey Brin.