The Annals of Internal Medicine reported this April of 2014 (Volume 160, number 7, page 507-509) that there is a concern amongst academic medicine as to the value and direction that some laboratories are provided when testing an individual’s genetic background. Rather surprisingly, I was about to have my own saliva tested. This was prompted by a patient of mine who told me about his testing and how much he enjoyed learning about his genetic “tree”. Then this article arrived the next day, as it were. It sent a tone of caution in my direction. Basically, the Annals concerns “generally fall into 4 categories: test validity, test utility, results management and data privacy”. The article raises this issue that physicians are not, as yet, educated as to how to counsel patients who present with their “data”. The Health Care System also could become overwhelmed with patients insisting further testing be done to identify or verify IF there is “anything to be worried about” when evaluating a “genetic report”. The main company behind this testing is called “23andMe”. The company’s press release on 25 November 2013 stated, “We recognize that we have not met the FDA’s expectations” but goes on to state that the company is “committed to fully engage with them”. The Annals finally states ” it would seem logical for the company (23andMe) to invest in research that determines the actual clinical value of their tests, and they should be expected to meet the same evidence standards as other device manufacturers under FDA jurisdiction”.
We shall see and follow this issue in upcoming blogs.