The earlier that cancer is diagnosed, the greater the chance of successful treatment and survival.1 Often, symptoms of cancer may not appear until later stages when treatment options may be more aggressive and less effective, and the chances of survival are lower.2
The Galleri multi-cancer early detection test detects more than 50 types of cancer through a routine blood draw with a low false-positive rate of 0.5%.3
When a cancer signal is detected, the Galleri test predicts the origin of the cancer signal with high accuracy to help guide the next steps to diagnosis. Using the Galleri test alongside existing screening tools is expected to improve early cancer detection for patients at an elevated risk of cancer, such as those aged 50 or older.
The Galleri test’s performance is supported by rigorous clinical studies with more than 20,000 participants representing diverse populations.3 – 5
The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older. The Galleri test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. Galleri is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of Galleri is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment.
Results should be interpreted by a healthcare provider in the context of medical history, clinical signs and symptoms. A test result of “Cancer Signal Not Detected” does not rule out cancer. A test result of “Cancer Signal Detected” requires confirmatory diagnostic evaluation by medically established procedures (e.g. imaging) to confirm cancer.
If cancer is not confirmed with further testing, it could mean that cancer is not present or testing was insufficient to detect cancer, including due to the cancer being located in a different part of the body. False-positive (a cancer signal detected when cancer is not present) and false-negative (a cancer signal not detected when cancer is present) test results do occur. Rx only.
GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists (CAP). 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. GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes.
Surveillance, Epidemiology, and End Results (SEER) Program (www.seer.cancer.gov) SEER*Stat Database: Incidence — SEER 18 Regs Research Data, Nov 2018 Submission. Includes persons aged 50 – 79 diagnosed 2006 – 2015 “Early/Localized” includes invasive localized tumors that have not spread beyond organ of origin, “Late/Metastasized” includes invasive cancers that have metastasized beyond the organ of origin to other parts of the body. Noone AM, Howlader N, Krapcho M, et al. (eds). SEER Cancer Statistics Review, 1975 – 2015, National Cancer Institute, Bethesda, MD, http://seer.cancer.gov/csr/1975_2015/, based on November 2017 SEER data submission, posted to the SEER website April 2018.
Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021 Jan;71(1):7 – 33.
Klein E, et al. Clinical validation of a targeted methylation·based multi-cancer early detection test. Oral presentation at: American Association for Cancer Research; April, 2021; LB013.