A saliva-based DNA service providing genetic reports based on ancestry and family history, 23andMe, recently announced a $60 million deal with Genentech for access to data on people with Parkinson’s. 23andMe’s personal genetic testing kits were approved for sale (at $199 per kit) in Canada last fall.
With the assistance of the Michael J. Fox Foundation, 23andMe has recruited 12,000 people with Parkinson’s (offering the kits free of charge) and will provide access to Genentech to 3,000 of those tested, who have agreed to donate their DNA for research purposes. It’s not known how many of these participants are Canadians. Genentech will need to follow up with research subjects to obtain further health information and/or medical records. It plans to conduct research into new targets for Parkinson’s drugs and diagnostic tests.
In late 2013 the U.S. FDA (Food and Drug Administration) told 23andMe that it could no longer return health information to its customers, out of concern that the information wasn’t accurate. Deemed a medical device in the U.S., 23andMe was ordered to cease providing medical information in its reports to consumers. Health Canada has determined that the kits are not therapeutic, so it only regulates the safety of the collection kit itself, not how the information from the genetic tests is reported and used.
Unlike the United States, Canada does not have genetic privacy or discrimination legislation. Consumers in Canada are vulnerable to discrimination and should be aware that there is no legislation that protects Canadians who participate in genetic research or undergo genetic testing. In the United States, Americans are protected under The Genetic Information Nondiscrimination Act (GINA). However, for Canadians, there is potential risk to their privacy as well as insurance and employment implications.
Parkinson Society Canada (PSC) is addressing these potential risks, advocating to protect Canadians against genetic discrimination. In December 2014, PSC President & CEO Joyce Gordon testified in favour of genetic fairness legislation to the Senate Committee on Human Rights. You can learn more about this advocacy work here.
In addition to privacy and discrimination issues, Canadians living with Parkinson’s disease and their families should be aware that 23andMe’s testing kits cannot confirm a Parkinson’s disease diagnosis. Only your physician or neurologist can make a diagnosis.