Now there’s a proactive tool to screen for cancer
Galleri® is a multi-cancer early detection test, a blood test that screens for many of the deadliest cancers before they become symptomatic,1,2,3 including those with no recommended screening tests today.2,3,4 See a list of what the Galleri test screens for.3
Screen for cancer before symptoms appear
Aggressive cancers can develop quickly and without symptoms. Cancers growing in the body shed DNA into the bloodstream, the DNA fragments can act like a unique "fingerprint" of cancer.3,5,6 The Galleri test may be able to detect such a “fingerprint” before a clinical diagnosis through conventional means.
Watch this short video to learn more about Galleri
The Galleri test is not a hereditary screening test and does not predict your future genetic risk for cancer. The Galleri test is a screening test and does not diagnose cancer. Diagnostic testing is required to confirm cancer.
Confidence in knowing you've done more to screen for cancer
The Galleri test gives you more control when it comes to cancer.
The Galleri test screens for a unique "fingerprint" of cancer from DNA fragments shed from cancer cells.1 Around 1% of people ages 50-79 are expected to receive a Cancer Signal Detected test result.1 This result will include the predicted tissue type or organ associated with the signal, called a Cancer Signal Origin (CSO). After diagnostic evaluation, around 40% of these people are expected to have a confirmed cancer diagnosis.
In study participants with a cancer diagnosis after a Cancer Signal Detected test result, the CSO was accurate 88% of the time.* The predicted CSO provides direction to your doctor on the cancer’s origin and helps guide the next steps in diagnosis.1
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.
*In the PATHFINDER study, Cancer Signal Origin (CSO) prediction accuracy was 88% for participants with a cancer diagnosis among study participants with a Cancer Signal Detected test result.
Backed by rigorous clinical evidence
The Galleri test was evaluated in clinical studies with over 20,000 participants.1,3,5 The test was developed by GRAIL and its clinical laboratory is certified by the International Organization for Standardization (ISO 15189), the Clinical Laboratory Improvement Amendments of 1988 (CLIA), and accredited by the College of American Pathologists (CAP).
GRAIL is transforming cancer screening
GRAIL is a leading healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is pioneering new technologies to continuously advance early cancer detection.
The Galleri test is the first innovation from GRAIL. In fact the idea for Galleri started with the same technology currently used in prenatal testing.7
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.
- 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
- American Cancer Society. Cancer facts & figures 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]
- 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 Sep;32(9):1167-77. doi: 10.1016/j.annonc.2021.05.806
- US Preventive Services Task Force. A,B,C grade recommendations, cancer, screenings. [cited 2023 Oct 23]. https://www.uspreventiveservicestaskforce.org/uspstf/topic_search_results
- Liu MC, Oxnard GR, Klein EA, et al. Sensitive and specific multi-cancer detection and localization using methylation signatures in cell-free DNA. Ann Oncol. 2020 Mar 30;31(6):745-59. doi: 10.1016/j.annonc.2020.02.011
- Thierry AR, El Messaoudi S, Gahan PB, et al. Origins, structures, and functions of circulating DNA in oncology. Cancer Metastasis Rev. 2016 Jul 8;35:347–76. doi: 10.1007/s10555-016-9629-x
- Bianchi DW, Chudova D, Sehnert AJ, et al. Noninvasive prenatal testing and incidental detection of occult maternal malignancies. JAMA. 2015 Jul 14;314(2):162-9. doi: 10.1001/jama.2015.7120