Last month, a mix-up at the genetic testing company 23andMe caused 87 people to receive incorrect results. In one case, a woman was told her son carried genes for a life-threatening disorder when in fact, he didn’t. Another woman who thought she was white, was told her genes resembled those of an African American. In a third case, an actual woman was told she was a man.
The gaffe has focused attention on the question of whether the government should begin to regulate the burgeoning genetic testing industry more aggressively.
Supporters of this view argue that some companies in the space have made claims that are not supported by fact, and that the results of genetic testing are too complicated for people to interpret by themselves. People who are told they don’t have genes that put them at very high risk for developing breast cancer might stop getting mammograms, for example.
The flip-side to the argument is that a heavy dose of regulation might stifle innovation and render the tests too expensive and unnecessarily difficult to access. In addition, it’s far from clear that the FDA has the resources to verify the complex scientific claims being made by genetic testing companies.
Amid the debate, the FDA has begun to intervene. This spring, it blocked an effort by Pathway Genomics to market genetic tests in drug stores. Soon thereafter, it notified 5 companies that were marketing testing kits over the Internet that their tests were medical devices which needed to pass through normal regulatory processes.
Despite these early interventions, genetic testing remains in the Wild West phase of commercial development. Caveat emptor.