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VOL. 37 | NO. 49 | Friday, December 06, 2013
23andMe genetic test to follow FDA order to halt test sales
MOUNTAIN VIEW, Calif. (AP) — Genetic testing company 23andMe Inc. will comply with a Food and Drug Administration directive to stop selling health-related genetic tests during a regulatory review.
The Mountain View, Calif., company said late Thursday that it will continue to provide ancestry-related information to customers and raw genetic data without interpretation. Customers who bought kits since the FDA order came out last month will be eligible for refunds.
FDA representatives did not immediately return a phone call from The Associated Press seeking comment on the company's announcement.
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.
Last month, the agency had ordered 23andMe to stop marketing its test, warning that erroneous results could cause customers to seek unnecessary or ineffective medical care. The FDA warning letter stated that even after numerous meetings and email exchanges with the company, the agency still had no assurance that the firm has analytically or clinically validated its technology.
23andMe sells its tests online. Customers receive a small tube in the mail, which they return to the company with a saliva sample for DNA analysis.
The company was co-founded by Anne Wojcicki, who recently separated from her husband, Google co-founder Sergey Brin. Both Google and Brin have invested millions in the privately held company over the years.