WASHINGTON – The Food and Drug Administration has ordered Google-backed genetic test maker 23andMe 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 email exchanges.” The agency orders 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 more than 5 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.
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.
The FDA letter suggests that regulators have gone to great lengths to try and work with the company, citing months of meetings and dozens of letters between the two parties.
“However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated” its technology, states the letter.
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 diseases like diabetes, heart disease and breast cancer. Regulators worry that false results from the test could cause patients to receive inadequate or inappropriate medical care.