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The Galleri® test: The first clinically-validated MCED test

The Galleri test can detect a signal shared by over 50 types of cancer with 99.5% specificity and predict the cancer signal origin with high accuracy to help guide next steps. This means that in approximately 200 people tested, only 1 person would be expected to receive a false positive result. In study participants, when the Galleri test detected cancer the first or second Cancer Signal Origin prediction was correct 88% of the time when cancer was found after diagnostic evaluation.1

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The Galleri test performance is backed by extensive clinical studies

The support and validation of GRAIL’s science is critical, that is why we have built what we believe to be the largest clinical trial program ever pursued in genomic medicine. We are collaborating with leading health systems, academic medical centers, and industry partners around the world to help make early detection accessible to as many people as possible.

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The Galleri test is complementary to routine screenings

The Galleri test is intended to complement routine single cancer screenings for more comprehensive early cancer detection. Routine screenings are recommended for certain patients for breast, cervical, colorectal, lung and prostate cancers.2

Only screening for a single cancer does not effectively address the high prevalence of cancer given the probability of diagnosis for a specific cancer is uncertain, and the occurrence of individual cancers is relatively low. One in two men and one in three women are diagnosed with some form of cancer in America in their lifetime.

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Instructions for Use
Important safety information

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.

Laboratory/test information
GRAIL’s 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. GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes.




1. Schrag D, McDonnall CH, Naduld L, et al. PATHFINDER: A Prospective Study of a Multi- Cancer Early Detection Blood Test. Presentation at European Society of Medical Oncology (ESMO) Congress September 9-13, 2022; Paris, France

2. United States Preventive Services Task Force (USPSTF)

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