In the weeks since the Food and Drug Administration told 23andMe that it must cease marketing its personal genome service there has been quite a bit of chatter about how the agency is being overly cautious, or too paternalistic, grinding up the gears of a fledgling industry while telling the American public that it knows better than them about what health information they can handle.
Those voices may have gone too far and may not recognize the tricky territory FDA is in today, writes Michael White, a systems biologist at Washington University in St. Louis, in Pacific Standard magazine.
At the same time it told 23andMe to stop selling its health-related services, FDA also approved the first next-generation DNA analysis system, Illumina's MiSeqDx, White notes.
White says that the approval shows FDA understands the "growing significance of genetic testing in medicine," but adds that the agency is dealing with a new set of questions. Here's a big issue: While most everyone agrees that people should have access to their own genomic information, what if the tests they take to get that information don't work?
In addition, the plummeting cost of sequencing means that genome-based medicine and personal health offerings are expanding rapidly.
"It sounds great in principle, but the result is a major headache for the FDA, because modern genetic medicine is demolishing regulatory concepts and categories that the agency has long used to ensure that drugs and diagnostics are safe and effective," White says.
The problem is that consumer genetics companies are blurring the lines between recreational genomics and medical tests. FDA is tasked with monitoring the latter for analytical and clinical validity. That may be easier said than done, particularly when tests analyze hundreds or thousands of genomic regions, when clinical validity can vary based on the individual mutation, and when new studies about these mutations are being released on a regular basis.
"It doesn’t help that these services are often advertised with the dubious claim that they will empower you to take your health into your own hands," White adds.