Ever since it became apparent that understanding individual genetic makeup and expression patterns could be used to guide medical treatment, entrepreneurs saw an opportunity to market directly to consumers. These tests can be a foundation for personalized medicine, but concern has been expressed about the quality of some tests and testing labs and about the actual clinical utility of the results. Until recently the companies have managed to escape significant attention from the FDA, but that is likely to change based on a recent Government Accounting Report finding substantial abuses. (GAO Report)
The GAO used fictitious consumers to contact the companies and have tests performed. The results were often contradictory from company-to-company and often at odds with the individual’s actual health history or concerns. Important limitations were often not mentioned. Expert follow-up consultations that the companies promised were usually of limited value. The companies made claims about the benefits or use of the tests that were inaccurate, such as the ability to predict what sports a child would be good at or to design supplements to enhance an individual’s health based on the results.
This report, coupled with the FDA’s initiative to provide greater oversight of these tests and to clarify and potentially strengthen the approval process for them, probably will slow up the move to personalized medicine. Although the NIH and FDA recognize the benefits of individual biochemistry guided medicine, clinical utility is the key and much more research is needed to clarify this in most cases and the physician community needs a lot of education and tools to figure out how to take advantage of the expanded knowledge afforded by these techniques. What personalized medicine doesn’t need is a black eye from quick-buck firms, from inaccurate and sloppy testing or from overhyped expectations of benefit which can’t be met. More regulation will help the industry prove itself in the long run.