An editorial published in last week’s issue of Nature, entitled “Transparency and honesty are essential if the genetic-testing industry is to live up to its potential,” encourages the FDA to go light on regulation with respect to the budding genetic testing industry. The article recognizes the fact that, as a relatively new commercial product, now is the time to set a precedent about how the industry should be treated. FDA regulation, they claim, “could easily have the effect of driving less than desirable players underground, where sub-standard tests will remain as easy to buy as black-market DVDs.” As an alternative to government quality control, the authors propose an international, online database where “test-makers would be required to upload data about their tests and the studies that back them.”

The article continues to say that “should it become clear that the [unregulated] system is allowing harm, then enhanced regulation will be appropriate.” Furthermore, “It is also worth noting that the scientists who have driven this revolution need to assume a prominent role in ensuring that its benefits are not mishandled.” We understand, from our study of networks and cascade behavior, that now, in its nascent years, it is indeed high time to set a precedent about how genetic testing as a commercial product should be treated. However, also from our study of cascade behavior, we also recognize an inherent danger in the unregulated, followed by regulated behavior.

Despite making information about genetic testing products available to all via an online database, there remains the potent factor of cascade behavior that may lead a population to ignore good data and simply follow the crowd. Regardless of the database, an unregulated market may end up promoting poor products despite accessible knowledge of superior goods.

Thus, perhaps a more sound approach would be to introduce FDA regulated endorsement on the initial products—that is, on promising, fledgling companies, right now. Those making the judgments on the FDA endorsements would be the aforementioned scientists who have “driven this revolution,” employed by the FDA. Thus, with the approval of those who understand the science behind genetic testing, and with the rigor of FDA safety and reliability studies, a network cascade to promote high-quality genetic tests can be generated. Essentially, using our understanding of networks, the quality of FDA regulation can be injected into the market without actually imposing regulation.

To wait until after the industry is established before creating a network cascade that would direct the market toward high-quality products would only incur massive expenses that could be avoided if action were to be taken now.

http://www.nature.com/nature/journal/v452/n7188/full/452666a.html