By Kathy Hibbs, Chief Legal and Regulatory Officer, 23andMe
A few days ago the US Food and Drug Administration accepted for review 23andMe’s submission for a new 510 (k) application. This submission is for one health report, and is part of the FDA’s regulatory review of our health product.
Although the submission focuses on a single rare but serious inherited condition we report to customers — Bloom syndrome — it is an important step in our work with the FDA in the coming months.
Once cleared, it will help 23andMe, and the FDA, establish the parameters for future submissions. More importantly, for our customers, it marks a baseline on the accuracy and validity of the information we report back to them. The submission includes robust validation data covering major components of our product such as the genotyping chip, software and saliva kit.
While we are still in the very early stages of this regulatory review process, we remain committed to transparency and keeping our customers as informed as possible. This by no means is the end of the process even for this one condition. It is likely that 23andMe will hear back from the FDA regarding the material we gave to them, and, we in turn will have to respond to those questions as we move forward. We are pleased to be moving forward with the FDA and committed to our company mission of empowering individuals with their genetic information.
If you would like to know more about the 510 (k) process, you can read more on the FDA’s website.