Clairvoyance and clinical practice
In recent weeks, it has come to light that British Columbia will be home to a lab that is expected to provide direct-to-consumer genetic testing services (DTC-GT). It should come as no surprise that this order-it-yourself service has been growing in popularity over the years; the idea that anyone can get information on their predispositions to illnesses and diseases by simply mailing in a saliva sample is hard to resist.
While this service is not new, it is believed that a lab such as this one that is operating independent of any research protocol will be the first of its kind in BC, thereby presenting unique challenges for this College and government. The Collège des médecins du Québec is also keeping a close eye on its own jurisdiction, as genetic testing for "personalized health care" has become a very active issue there.
In general, much of genetic testing is at the research end of the spectrum as opposed to being a standard of care. Compared to traditional genetic testing (e.g. testing for single gene mutations for diseases such as Huntington’s disease) based on a referral from the treating physician to the laboratory physician, DTC-GT tests are marketed to patients who are well and the results may be of uncertain clinical utility. Unlike traditional genetic tests which include pre- and post-test counselling, DTC-GT often predict probability of certain disease states, many of which may be greatly influenced by environmental and lifestyle factors.
Currently the College’s Diagnostic Accreditation Program does not accredit genetic testing laboratories. Preliminary conversations with the Ministry of Health are already underway on what patient safety and consumer protections are necessary in this new emerging, highly technical business of genomics testing. Besides the uncertain clinical utility of DTC-GTs, significant privacy issues exist and must also be considered.
Doctors of BC recently released a policy statement on DTC-GT, and I encourage you to read this. With all the promise and hype surrounding this technology, the most important of questions facing physicians is how do they parlay these reports into factual information to patients? The short answer is that more investigation and conversations with health partners are needed. The College is committed to being part of the conversation, and ensuring that patient safety and public protection is at the forefront, whether that be through accreditation of facilities, or through guiding the profession, or both.
Registrants may be interested in reading professor Timothy Caulfield’s analysis on this topic in a recent BMJ blog: Genetics and Personalized Medicine: Where’s the Revolution?
H.M. Oetter, MD
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