It’s all over the news today–the GAO reports that Direct-To-Consumer companies are providing poor-quality services with deceptive marketing. It is not the technologies that the companies that were investigated used to determine the genetic profiles of the subjects that are in question, but rather the interpretation of the results and subsequent marketing that were found to be of poor quality and deceptive. That doesn’t mean that the technical quality of these companies is up-to-snuff, either (recall the recent sample mix-up at 23 and Me).
The problem here is that these DTC companies are marching under the banner of “freedom to look at my own DNA”, all the while providing a service that is of essentially no value. The one or two or dozen SNPs that comprise their “risk predictor” for a given condition have not been validated as providing useful information on the condition in question. To quote Teri Manolio regarding Genome-Wide Association Studies of SNPs in general, “What is becoming clear from these early attempts at genetically based risk assessment is that currently known variants explain too little about the risk of disease occurrence to be of clinically useful predictive value.” (NEJM 363:166-176, 2010).
This is all unfortunate for the companies that are trying to develop useful products based on genetic information, such as Genomic Health appears to be. These companies are doing the ground work to develop meaningful products and prove their value, unlike the DTC companies.
It is no surprise to me, given the potential uses and potential abuse of genetic information, that the FDA would step in to this field, as it recently has said it is going to do. More of a hassle for the companies doing good work in the field, certainly, but this is exactly what the Food, Drug, and Cosmetic Act of 1938 was about.