Invitae receives FDA market authorization for Common Hereditary Cancers Panel

Invitae gained FDA market authorization for its Common Hereditary Cancers Panel. This represents the first broad panel that is used to identify germline variants associated with hereditary cancer to gain market authorization from the FDA. Through this application, Invitae was able to establish a new category of device based on its testing technology and methodology which provides potential marketing differentiation and opportunities for its largest testing category. In 2021, the company submitted a de novo application using the Common Hereditary Cancers Panel as an example of a methods-based approach to validation. The FDA worked closely with Invitae to review the test and its supporting data, which led to this authorization being granted on September 29, 2023.