Personal Genome Service regulatory update

FDA approved a 510(k) under the de novo pathway for a single-condition health report for Bloom syndrome generated with the company’s Personal Genome Service (PGS). Bloom syndrome is an inherited disorder characterized by short stature, sun-sensitive skin changes, an increased risk of cancer, and other health problems.

This is the first direct-to-consumer test approved in the U.S. As part of the approval, FDA is requiring 23andMe to provide the results “in a way that consumers can understand and use” and information to consumers about how to access a board-certified clinical molecular geneticist. FDA said it will classify carrier screening tests as class II devices and exempt them from premarket review. ...