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A controversial California company is going to start selling genetic test kits in Canada, and provide the information on more than 100 health conditions to its Canadian clients, despite the fact that the U.S. regulator forbids it from doing so south of the border.
Anne Wojcicki, CEO and co-founder of 23andMe Inc. of Mountain View, Calif., said she is confident Health Canada will not impose the same restrictions on the company as the U.S. Food and Drug Administration (FDA) has. “We’ve had extensive discussions with Health Canada. They’ve determined we’re not a therapeutic product so we don’t need pre-market approval,” she said in an interview.
A Health Canada spokesman said the agency regulates only the safety of the collection kit, not how information from genetic tests is used; medical information and privacy issues are a provincial responsibility.
The U.S. company, a pioneer in the sale of direct-to-consumer genetic tests, was founded in 2006. It provided customers with genealogical and health information based on more than 200 genetic markers, gleaned from a sample of spit. Initially, the “health report”...