First, let me say that I'm very much in favor of the direction that 23andMe is headed. Personalized genetic medicine is the future. Generic small molecule treatments (and by generic, I mean that they're given to patients based on the disease and not based on the patient+disease profile) have pretty much hit their limit of efficacy and biologics are a lot like supersonic airliners: they'd be great in theory if there weren't so many problems with them in practice.

I also sympathise with the way that the GAO, the FDA, and a number of other groups that have been weighing in on this issue have been lumping together 23andMe with some of the less reputable players in this burgeoning industry.

That said, I still don't agree with what 23andMe is doing. I've nearly completed a Ph.D. in computational biochemistry and have been helping my wife with her thesis in cell signaling, and the only thing I can tell you about the information contained in a genetic profile that 23andMe provides you is that you can't really tell much, if anything, from the profile that 23andMe provides you. Even supposedly straight-forward genetics like the presumably Mendelian pattern of inheritance in CFTR SNPs can get complicated fast. For example: http://www.ncbi.nlm.nih.gov/pubmed/14966131

Of course, the real problem with 23andMe isn't with 23andMe but with the FDA. The FDA's job, first and foremost, is to keep people safe. IT IS NOT THE FDA's CONCERN TO SEE NEW TREATMENTS DEVELOPED! The result of this is that the medical community and the pharmaceutical industry are caught in a bit of a catch-22. Everyone that I've spoken too (including past CSO's of large-name pharmaceutical companies) recognizes that including genetic profiling of patients in drug trials might reveal that different people benefit from some drugs more than others, and that this is linked to genetics. In fact, you can probably recognize this yourself: When you get a headache, what do you reach for? For me, Ibuprofen does the trick, but Acetaminophen (Paracetemol) does nothing. For my wife, it's the reverse. This is almost definitely linked to genetics.

The problem is that genetic profiling for drug trials is expensive and, get this, as of yet unproven to make a difference! Therefore, even if a pharmaceutical company went to the expense of including genetic profiling in their drug trial, the FDA would reject the results based on the fact that genetic profiling is unproven. So, nobody does genetic profiling. So you can't prove the usefulness of genetic profiling. etc.

Now, you might think that 23andMe has a chance of solving this issue, by allowing people to take control of their own genetic profiling, but I think they're actually doing more harm than good. Unless you are highly trained in genetics and keep up with recent literature, you're not going to know what to do with that profile. If you bring that profile to a doctor, they will pretty much have to disregard it without a second thought (see FDA argument above). Honestly, with the current state of medical research and pharmaceutical regulation, a 23andMe profile is worth the paper you printed it on. What's worse, the more doctors get pestered with people bringing in their own profiles, the less likely they are to pay heed to any of it, and the distraction that this causes the FDA, worrying about whether they should regulate 23andMe or not, prevents the root issue from being addressed.

I liken 23andMe to Quest Diagnostics. If you've visited a doctor recently, you're probably familiar with Quest. But when was the last time you went to Quest asking for a blood test without being prompted to do so by a physician? Honestly, you'd probably learn more on your own looking at the results of a cholesterol test or CBC than by perusing your own genetic profile. Until the U.S. (or, more likely these days, the E.U.) makes a major push for research into personalized genetic medicine, 23andMe will be little more than a novelty.