Next-generation sequencing, or NGS, has been touted as a potential game-changer in health care, but it is still in early stages and not many NGS products have passed through FDA yet. But, even with its limited experience, the agency has noticed some repeat issues in NGS submissions that it hopes future sponsors can learn from.
A significant promise of NGS lies in its potential to help personalize treatments to patients based on their genetic makeup. It is the foundation of bold research projects, including some...