Self-governance threatened, provincial association says.

trating major drug chains and the Internet. “None of the genetic tests now offered directly to consumers has undergone premarket review by FDA to ensure that the test results being provided to patients are accurate, reliable, and clinically meaningful.” The FDA recently warned 19 companies that it considers genetic tests as meeting “the statutory definition of a medical device,” which would make them subject to full regulatory review. The FDA is also examining standardization of direct-to-consumer tests (www.cmaj .ca /cgi/doi/10.1503 /cmaj .109-3669). In Ottawa, Health Canada is taking a far more relaxed approach. Personal test kits are “neither prohibited by law, nor subject to federal regulation,” said spokesperson Christelle Legault in an email. But the department’s stance is dramatically different — and far more cautious — with regard to genetic tests employed by drug developers. All devices intended to be used for pharmacogenetic testing “are classified as Class III medical devices and require a premarket scientific assessment of [their] safety and effectiveness,” federal guidelines stipulate, (www.hc-sc.gc.ca /dhp mps/brgtherap/applic-demande /guides /pharmaco/pharmaco_guid_ld-eng.php). Such genetic testing devices must be licensed or authorized “if the test results are to be used for diagnostic purposes, patient management, or are to be submitted to Health Canada in support of a clinical trial application or drug submission” as the devices may have “a profound impact on the safety and effectiveness of the drug for which the assay/test is performed,” the guidelines add. — Paul Christopher Webster, Toronto, Ont.