Rethink cancer screening for your health system or provider network
Screen for many of the deadliest cancers with a single blood draw1,2.
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 signal results do occur. The Galleri test should be used in addition to healthcare provider recommended screening tests.
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 signal results do occur. The Galleri test should be used in addition to healthcare provider recommended screening tests.
Leading organizations at the forefront of cancer screening with the Galleri test
How Galleri Works
Galleri screens for many of the deadliest cancers before they become symptomatic, including those with no recommended screening tests today, such as pancreatic or ovarian.1,7,8*
The Galleri test identifies DNA shed by cancer cells into the bloodstream. For patients who receive a cancer signal detected result, the Galleri test will predict the most likely origin of the cancer signal, helping guide the diagnostic workup.1
*Sensitivity in study participants with pancreatic cancer was 83.7% (61.9% for stage I, 60.0% stage II, 85.7% stage III, 95.9% stage IV) and ovarian cancer was 83.1% (50.0% for stage I, 80.0% stage II, 87.1% stage III, 94.7% stage IV).
Galleri is a screening test and does not diagnose cancer. Diagnostic testing is needed to confirm cancer. Galleri should be used in addition to healthcare provider recommended screening tests.
“Multi-cancer early detection tests should be added to routine cancer screening, and that's what we're doing here at Adventist Health.”
Dr. Tyler Kang
Medical Oncologist and Medical Director
Adventist Health Martin O'Neill Cancer Center
‡The PATHFINDER study was conducted with an earlier version of Galleri. Participants responding satisfied, very satisfied, or extremely satisfied to the following question: “Taking all things into account, how satisfied or dissatisfied are you with the multi-cancer early detection test?”
Validated by rigorous clinical studies, the Galleri test detects abnormalities in the methylation patterns of cell-free DNA (cfDNA) that could indicate the presence of cancer. When used alongside guideline recommended screening tests, the Galleri test can improve the chance of finding a cancer signal early.
We collaborated with leading cancer institutes to study the Galleri test, including
Learn more about Galleri
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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.
- Klein EA, Richards D, Cohn A, et al. Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set. Ann Oncol. 2021;32(9):1167-77. DOI: https://doi.org/10.1016/j.annonc.2021.05.806.
- 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/SO140-6736(23)-01700-2.
- Market research GRAIL, Inc. data on file GA-2022-0089.
- Surveillance, Epidemiology, and End Results (SEER) Program (seer.cancer.gov) SEER*Stat Database: Incidence — SEER 18 Regs Research Data, Nov 2018 Sub. Includes persons aged 50 – 79 diagnosed 2006 – 2015. “Early/Localized” includes invasive localized tumors that have not spread beyond organ of origin. “Late/Distant Metastases” includes invasive cancers that have metastasized beyond the organ of origin to other parts of the body. Data on file GA-2021-004.
- GRAIL, Inc. Data on File GA-2022-0089.
- Reddy SR, et al. Cost of cancer management by stage at diagnosis among Medicare beneficiaries. Curr Med Res Opin. 2022;38(8):1285-1294. DOI: doi.org/10.1080/03007995.2022.2047536.
- American Cancer Society. Cancer facts & figures [Figure 3] 2022. https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2022.html [GRAIL, LLC. Data on file: GA-2021-0065].
- US Preventive Services Task Force. A,B,C grade recommendations, cancer, screenings [cited 2023 Oct 23]. https://www.uspreventiveservicestaskforce.org/uspstf/topic_search_results
- Hubbell E, Clarke C, Aravanis A, et al. Modeled reductions in late-stage cancer with a multi-cancer early detection test. Cancer Epidemiol Biomarkers Prev. 2021;30:460-8. DOI: doi.org/10.1158/1055-9965.EPI-20-1134.
- Schrag D, et al. Evaluation of Anxiety, Distress and Satisfaction Using a Multi-Cancer Early Detection (MCED) Test. Presentation at European Society of Medical Oncology (ESMO) Congress September 9-13, 2022; Paris, France.