TORONTO -- A California-based genetics company that offers both health and ancestry information has announced it is expanding into Canada.
The company, called 23andMe, now offers Canadians access to their genetic information "to better understand their health and traits" and genetic ancestry.
However, the U.S. Food and Drug Administration told the Mountain View, Calif.-based company in November 2013 to stop marketing health-related reports as part of its home-testing kits.
The company had offered saliva-testing kits that customers could send back for reports on their heritage and genetic risk for dozens of health conditions.
In a warning letter posted online, the FDA said the company had not shown the tests are safe or effective. It warned that erroneous results could cause customers to seek unnecessary or ineffective medical care.
In announcing its Canadian launch, 23andMe noted that its health reports are "not cleared by the FDA" and can only be purchased in Canada by Canadians. It said American customers may purchase their ancestry-only product.
But Canadians, it said, will have access to "108 health-related reports."
It said they include "genetic risk factors for various health conditions, drug response, trait reports and inherited conditions."
The company also said more than 20,000 Canadians have already used 23andMe "to explore their own genetic information."
"The health information available to Canadians focuses on individual genetic markers with well-established associations that have clinical validity," said 23andMe CEO and co-founder Anne Wojcicki.
