Here Comes the FDA

Maybe the FDA could set up a sort of Consumer Reports for genetic testing.

Over the last few years, a bunch of companies have sprouted up that offer genetic testing over the Internet. The most controversial of these are the ones that offer consumers the chance to predict their future health risks.

These particular direct to consumer (DTC) tests took a real kick in the teeth from Congress this month. It was a big enough wallop that I don’t think the companies will be able to survive in their current form. The real question now is what they will look like when all of this shakes out.

There has been some low level concern by the FDA about this sort of testing for quite a while now. But what really focused their attention was when a small company from San Diego made plans to offer their test through Walgreens. What the FDA saw was a test that promised more than it could deliver.

To be honest, this is true in one way or another about most if not all of these genetic testing companies. Few of them are able to deliver everything that many consumers think they can.


So the FDA has set out to right this wrong. Unfortunately, because of the industry’s lack of organization, the FDA lumps all these testing companies together. This is not fair.

Some companies like 23andMe, deCODEme and Navigeneics are basically good companies that need some FDA guidance. Other companies are rip-offs that should be shut down. One of the genetic testing industry’s tasks now is to provide the FDA with the tools to distinguish between these two groups of companies.

What might help is some sort of Better Business Bureau for genetic testing. Or maybe some sort of self policing umbrella organization that only the best companies can join. Or some outside group that evaluates each company. Any of these would help both Congress and consumers have a better idea about which companies they should use for their testing.

These companies can already be CLIA certified but that isn’t necessarily that helpful from a results perspective. It is important in that it tells a consumer that the company runs the tests very well according to professional standards. What it doesn’t do is tell consumers which claims are believable, which ones are iffy, and which ones are straight out lies.

Even though it will be very tricky to police the results, these companies need to figure out a way to do this or they’ll continue to get lumped together. And consumers will lose the chance to get testing through some of the better companies.

Maybe the FDA could set up a sort of Consumer Reports for genetic testing. It would be staffed by a few genetic scientists who would look at the scientific merit of these tests and determine whether the claims are true or not. This would then be published on a website and companies that were up to snuff would get a seal of approval.

Right now I don’t think any company except maybe DNA Direct would get that seal. So maybe we need some sort of rating system instead. One DNA helix means stay away, five means a perfectly legitimate company, etc. This could let consumers know which are the better companies without the FDA having to straightjacket the industry into irrelevance.

I'll tackle the problem of interpreting and presenting data in my next blog. What I’ll try to do is propose some ways to present the data so that any potential customers won’t be bamboozled (or at least minimize the risk).

Before I leave, I do want to voice a word of caution. A working assumption in the discussion here is that the better companies are pretty good. A sting operation by the GAO (no, really) may cast some doubt on this.

As you listen to this YouTube video, think about the fact that the first example is from Navigenics, one of the good companies. The good ones need to be more careful with their communications to the public or they may be wrongfully lumped in with the bad ones. Or with too many examples like this, maybe I should say rightfully…

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