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" was considered an educational product that did not require regulation, but last November the FDA ruled that the test kit was a medical device that needed to be regulated.
In a strongly worded letter, the FDA cautioned that the tests and the accompanying analysis were not necessarily accurate and the health information could prompt consumers to seek unnecessary and harmful medical interventions.
The kits continue to be sold, but 23andMe provides only genealogical information to its clients.
Ms. Wojcicki said the company is co-operating fully with the FDA and committed to getting the product approved in the United States, but meanwhile it is expanding globally. The company has more than 750,000 clients in more than 50 countries, including 20,000 in Canada who acquired the kits in the U.S.
"Every country has a different regulatory environment, and that presents different challenges and opportunities," Ms. Wojcicki said.
She noted too that the health information offered in Canada is different from what was initially offered in the U.S. "We receive and respond to feedback and we continue to evolve, including redesigning our health reports," she said.
In the U.S., the direct-to-consumer genetic test initially sold for $999 (U.S.). Later, in a bid to expand the market, the price was lowered to $99 and, as technology improved, clients were offered information on more than 250 health conditions that had genetic markers.
In Canada, the genetic test kit will cost $199 (Canadian). The health reports offered by 23andMe will include information on 108 health conditions where the scientific evidence is strongest, as well as ancestry information.
Timothy Caulfield, who holds the Canada Research Chair in Health Law and Policy at the University of Alberta, said he is skeptical about the usefulness of this sort of genetic testing, but assumes it will be relatively popular.
"On a personal level, I find it entertaining," he said. "But will having this information improve your health? It's doubtful."
Prof. Caulfield said his worry is that people will place too much importance on learning, for example, that they have one of the genetic traits that put them at increased risk of developing heart disease. "You have to keep this stuff in perspective," he said. "Controlling your blood pressure is way more important and is going to have much more impact, and you don't need a genetic test for that."
Bartha Knoppers, director of the Centre of Genomics and Policy at McGill University, and a global expert on the ethical aspects of genetics, expressed similar concerns.
"Genetic testing sounds impressive, but how much more is it going to tell you about your health risks that your mother hasn't already told you?" she said.
Jeff Pollard, scientific director of 23andMe, said that, in its health reports, the company tries to provide the latest scientific information on what various genetic markers might mean, but stresses that the findings should always be discussed with a health professional. He said clients should be thoughtful about how they share the data.
"Overall, though, we believe this information is empowering people," Dr. Pollard said. "Genetic information can be powerful and we think this is going to drive precision and personalized medicine."
Editor's Note: 23andMe Inc. is based in Mountain View, California, not Palo Alto, as reported in an earlier version of this story.