After a long legal battle, the Food and Drug Administration granted a private California-based biotechnology company the authority to test for Bloom syndrome carrier status Thursday.
This is the first time the government has approved a direct-to-consumer genetic test. The company is called 23andMe.
Bloom syndrome is a rare genetic disorder, generally impacting the Ashkenazi Jewish population. Individuals with Bloom syndrome are categorized by their stunted growth, sensitivity to the sun, and telangiectatic erythema.
Often, people with Bloom syndrome develop cancer. There are no individuals with Bloom syndrome reported to reach the age of 50. Carriers of Bloom syndrome, however, display no symptoms, which is why it is important to test for carrier status.
By mailing in a saliva sample, 23andMe allows users to learn information about their ancestry. Previously, 23andMe allowed its customers to access detailed information about their genetic predisposition to certain diseases, disorders, inherited conditions and carrier status.
But on Nov. 22, 2013, the FDA ordered 23andMe to stop offering its customers the ability to receive their health report. According to the FDA, “serious concerns are raised if test results are not adequately understood by patients or if incorrect test results are reported.”
The FDA believed individuals would make medical decisions based off of their 23andMe results without first consulting a medical professional.
People who purchased 23andMe kits prior to the FDA’s decision were still able to view their health risk information. New customers, however, were not able to access the health feature.
With the approval from the FDA, 23andMe now has a precedent to begin restoring part of its health report feature.