This is a prospective, multi-center interventional study of the Galleri multi-cancer early detection test with return of test results for participants enrolled through healthcare systems in North America. The purpose of this study is to evaluate the safety and performance of the Galleri test in a population of individuals aged 50 years and older who are not actively being evaluated or treated for cancer. Participants with a “cancer signal detected” test result will receive targeted diagnostic procedures based on the predicted cancer signal origin(s) to determine if cancer is present. The number and types of diagnostic procedures needed to achieve diagnostic resolution will be assessed. Participant-reported outcomes will be collected at several time points to assess perceptions about the multi-cancer early detection test.
The study will enroll approximately 20,000 eligible participants over an anticipated enrollment period of approximately 18 months at clinical institutions within North America. Participants will be actively followed for approximately 3 years.