Last week, proponents of low-cost personalized genetics testing made inroads with regulators when the Food and Drug Administration agreed to accept the first 510(k) health-report submission from 23andMe. It is a major first step if the company hopes to be awarded FDA approval to once again sell its $99 health report product, which previously, customers could use to learn the genetic likelihood that they are to encounter a disease like Alzheimer's.
"This submission is for one health report, and part of the FDA's regulatory review of our health product," wrote Kathy Hibbs, 23andMe's chief legal and regulatory officer in a blog post. The submission in this instance focuses on a single inherited condition called Bloom syndrome. Now, the FDA will have 90 days to critique the submission, which will help 23andMe establish the parameters for future reports.
"Once cleared, we expect this submission will provide 23andMe with a foundation to accelerate the process for future submissions," a company representative tells Fast Company in an email.
23andMe ceased providing new U.S. customers with health data last fall, after the FDA sent CEO Anne Wojcicki a stern warning letter stating that the service was being sold "without marketing clearance or approval in violation of the Federal Food, Drug, and Cosmetic Act." 23andMe's ancestry product—which will tell a user what percentage of their DNA is neanderthal, for example—is still for available for purchase, since it does not require FDA approval.
Personalized genetic testing is a hot-button issue in the medical field. Critics argue that without proper context and interpretation, which few doctors are qualified to provide, genomics data can do more harm than good when placed in the hands of customers—especially if the results are scary.
"While we are still in the very early stages of the regulatory review process," added a 23andMe representative, "we remain committed to transparency and keeping consumers as informed as possible."