A California company offering a genetic testing service that claims to pinpoint both health conditions and genetic background has begun operating in Canada, despite being blocked by the U.S. health regulator from offering its full service.
The company 23andme, founded in 2006 by CEO Anne Wojcicki, tests for about 100 health markers based on a sample of your saliva.
Customers apply for the testing kit online, submit a sample and get a response in two to six weeks via email, Wojcicki said in an interview with CBC’s The Exchange with Amanda Lang.
“What we do is we look at your health and your ancestry. That could be things like drug response — are you likely to respond to medication or not? Disease risks — are you susceptible to certain diseases? And ancestry information — where are you from in the world?” she said.
“And one more thing in the medical world, which is your carrier status. Is there something like cystic fibrosis …that you’re going to pass on to one of your children?”
FDA cracks down on health information
The U.S. Food and Drug Administration isn’t worried about the genetics of ancestry, which may tell you where in the world an ancient ancestor once lived.
But it blocked 23andme from sending health information to customers of its genetic testing kits in the U.S.
“The FDA believes that we are a medical device, so we are going through the medical device review process. In Canada we are working with health authorities and they have deemed that we are non-therapeutic and therefore we don’t need pre-market clearance,” Wojcicki said.
She argues that the kind of health information the test can reveal can help people make informed decisions about their future.
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The BRCA gene test for breast cancer — the same gene Angelina Jolie discovered she carried before opting for full mastectomy — is one example.
“We are finding individuals who otherwise would never be screened,” she said.
But that test is already offered in the Canadian health system, at no cost to people at risk, with the additional service of genetic counselling as individuals receive test results and decide what to do.
Genetic testing support
Stuart Nicholls, post-doctoral fellow at the University of Ottawa's faculty of medicine, said there is concern about people receiving this information from a testing kit, with no help in understanding what their options are.
“This is one of the concerns that people have raised, just how useful is this information and are there potentially concerns about maybe making people more anxious about their health and making them worry,” he told CBC.
He is doubtful that people will know how to interpret the kinds of risk factors they may learn from a genetic test on their own, without the help of a doctor or counsellor. Prenatal testing, for example, which gives odds of a child having a health disorder, is a complex field and difficult to understand.
“There's also no evidence that if you received a result that you were more likely to, say, get heart disease, that you would make the necessary lifestyle changes to address that risk,” he said.
Timothy Caulfield, a researcher in health law and policy at the University of Alberta, said he was surprised 23andme came into Canada when it has unresolved issues with the U.S. regulator.
“The FDA in the U.S. thought that their health claims were not supported by the evidence. At a minimum, they haven’t gone through the process to get approval from the FDA to make the kind of claims they were making about diagnosis and future health risks,” he said.
Caulfield said there may be pressure on the medical system for unnecessary testing as people take their findings to their family doctor.
“I’m skeptical about the value of this kind of genetic information. We’re finding that the impact of individual genes or clusters, as opposed to the risks that we already know — being overweight, smoking, etc. — is not significant,” he said.
What about privacy?
Another concern has been raised about the privacy of your genetic information and how 23andme will use it.
Wojcicki said consumers will be able to draw on the large database of health information it expects to accumulate through testing.
“Instead of having the pharma companies and researchers in the world looking at the discoveries, we can actually mobilize and we can be the ones actually driving this research and saying we want to know which medications are working for us,” she said.
However, Canada’s privacy commissioner has raised concerns about the privacy of genetic tests.
At this time, there are no laws in Canada that specifically address the use of genetic test results by insurance companies, the privacy commission noted in a research paper this July.
The Canadian Life and Health Insurance Association has agreed its members will never require a genetic test from a customer, but say that if there is such a test, “the insurer would request access to the information, just as it would for other aspects of the applicant’s health history.”