Disclaimers and Resources:
*The Galleri test does not detect a signal for all cancers. Not all cancers can be detected in the blood. False positive and false negative results do occur. 1 in 100 can expect to receive a CSD result, and approximately 60% of these individuals will receive a confirmed cancer diagnosis. The overall sensitivity in study participants with head and neck cancer was 85.7% (63.2% for stage I, 82.4% stage II, 84.2% stage III, 96.0% stage IV).
**“Early/Localized” includes invasive localized tumors that have not spread beyond the organ of origin; “Late/Metastasized” includes invasive cancers that have metastasized beyond the organ of origin to other parts of the body.
***Galleri is a screening test and does not diagnose cancer. Diagnostic testing is needed to confirm cancer. The Galleri test is not a genetic risk assessment and does not predict future genetic risk for cancer. The Galleri test does not detect a signal for all cancers and not all cancers can be detected in the blood. False positive and false/negative results do occur. Galleri should be used in addition to healthcare provider recommended screening tests.
Important Safety Information: The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those age 50 or older. The test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. The Galleri test is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of the test is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment.
Lab / Test information: The GRAIL clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. The Galleri test was developed and its performance characteristics were determined by GRAIL. The Galleri test has not been cleared or approved by the Food and Drug Administration. This test is not Health Canada or FDA approved, and has not been endorsed by any professional medical societies at this time. The GRAIL clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes.
1 Extrapolated from cancer death rates available at https://cancer.ca/en/research/cancer-statistics/cancer-statistics-at-a-glance [cited on Oct 14, 2025]
2 SEER Stat Database: Incidence - SEER 18 Regs Research Data, Nov 2017 Sub. Includes persons aged 50+ diagnosed 2006-2015. GRAIL Ddata on file GA-2021-0065
3 American Association for Cancer Research. Cancer progress report 2023. https://cancerprogressreport.aacr.org/progress/
4 Schrag D, Beer TM, McDonnell CH, et al. Blood-based tests for multi-cancer early detection (PATHFINDER): a prospective cohort study. Lancet. 2023;402:1251-1260. doi: 10.1016/S0140-6736(23)01700-2
5 Nabavizadeh N, McDonnell C, Kurbegov D, et al. Safety and Performance of a Multi-Cancer Early Detection (MCED) Test in an Intended-Use Population: Initial Results from the Registrational PATHFINDER 2 Study. ESMO 2025. Presentation LBA64.