Order the Galleri® test
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Why choose the Galleri® test
Gallieri is the only available multi-cancer early detection blood test with demonstrated performance in both case-control and interventional, intended-use studies1-4*
Screens for over 50 cancer types,
with high sensitivity for many of the deadliest cancers in early stages1,5†
>7x as many cancers detected
when added to standard-of-care screening for breast, cervical, colorectal, and lung cancers.3‡
Lowest false positive rate
of any MCED test at 0.4%3,6§
Predicts the cancer signal origin
with high accuracy7
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. The Galleri test should be used in addition to healthcare provider recommended screening tests.
*The Galleri test’s key performance metrics were derived from the outcomes of an interventional clinical study of patients [individuals] presenting for screening without clinical suspicion of cancer, a study population that reflects the intended use population.
†7 of 12 cancers that account for two-thirds of US cancer deaths have a stage I-II sensitivity of greater than or equal to 50%. ‡USPSTF A or B rating, based on the first ~25,000 participants with 1 year of follow-up. §Test performance metrics do not represent results of a head-to-head comparative study. Separate studies have different designs, objectives, and participant populations, which limits the ability to draw conclusions about comparative performance.
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Have a question?
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 No Cancer Signal 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.
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. The GRAIL clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes.
1. Klein EA, et al. Ann Oncol. 2021;32(9):1167-77.
2. Schrag D, et al. Lancet. 2023;402(10409):1251-60.Inc.
3. Nabavizadeh N, et al. Safety and performance of MCED test in an intended-use population: initial results from the registrational
PATHFINDER 2 study [proffered presentation]. ESMO Congress; 2025 Oct 17-21; Berlin.
4. GRAIL, Inc. Demonstrated performance in
individuals screened for cancer. [Data on file: GR-2025-0257]
5. GRAIL, Inc. CCGA3 Stage I/II Sensitivity [Data on file: GA-2023-0113]
6. GRAIL, Inc. False positive rate. [Data on file: GR-2025-0256]
7. Enhanced Cancer Signal Origin prediction. [GRAIL, Inc. Data on file:
VV-TMF-59592]