Now there’s a proactive tool to screen for cancer -Galleri®
The Galleri test is a clinically-validated blood test. The Galleri test is supported by clinical studies with over 20,000 participants.1,2
Multi-cancer early detection testing may feel brand new, but it’s actually based on common and widely adopted science. In fact, the idea for Galleri started with the same technology currently used in prenatal testing.3
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. Adding the Galleri test to guideline recommended screening tests allows you to do more to screen for cancer.6
We collaborated with leading cancer institutes to study the Galleri test, including
50+ types of cancer identified2
The Galleri test screens for a signal shared by over 50 cancer types, most lacking recommended screening tests.1,4 In a clinical study with a shared cancer signal, adding the Galleri test to recommended single-cancer screening approximately doubled the number of cancers detected with recommended screening alone.2
Today, doctors screen individually for 5 specific cancers — colorectal, lung (for those at risk), breast, cervical, and prostate. While these single-cancer screenings play an important role, adding the Galleri test allows you to go beyond these 5 cancers to screen for additional cancers, such as stomach and pancreatic.1,4*
Galleri is a screening test and does not diagnose cancer. Diagnostic testing is needed to confirm cancer. The Galleri test does not detect a signal for all cancers and not all cancers can be detected in the blood.
*Sensitivity in study participants with stomach cancer was 66.7% overall (16.7% for stage I, 50.0% stage II, 80% stage III, 100% stage IV), and pancreatic cancer was 83.7% overall (61.9% for stage I, 60.0% stage II, 85.7% stage III, 95.9% stage IV).
Low false positive rate
The false positive rate is the proportion of people without cancer who receive a Cancer Signal Detected result.
The Galleri test has a false positive rate of just 0.5% among those without cancer.1,2 Meaning, if 200 people who don’t have cancer get the test, only one person will receive a false positive test result.1
The low false positive rate minimizes the chances that an individual without cancer receives a Cancer Signal Detected result and can reduce unnecessary diagnostic procedures to confirm cancer.
False positive and false negative results do occur.
Highly accurate prediction of the cancer origin
The Galleri test screens for a unique “fingerprint” of cancer from DNA fragments shed from cancer cells and provides direction to your healthcare provider on the cancer’s origin and helps to guide the next steps for diagnosis.2*
Around 1% of people ages 50-79 are expected to receive a Cancer Signal Detected test result. This result will include the predicted tissue type or organ associated with the signal, called a Cancer Signal Origin (CSO). There are 18 possible Cancer Signal Origins. After diagnostic evaluation, around 40% of these people are expected to have a confirmed cancer diagnosis.
In a clinical study, people with a cancer diagnosis following a Cancer Signal Detected result, the CSO was accurate 93.4% of the time. This helps your healthcare provider select the appropriate diagnostic tests to confirm cancer. If the predicted Cancer Signal Origin does not result in a cancer diagnosis, it could mean the cancer is not present, limitation of diagnostics testing, or incorrect cancer signal origin.
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. Galleri should be used in addition to healthcare provider recommended screening tests.
*GRAIL, Inc. Data on file: VV-TMF-59592
Screen for some of the deadliest cancers
The Galleri test screens for a unique "fingerprint" in many of the deadliest cancers before they become symptomatic — through a simple blood draw.1,5
Deadly cancers can develop quickly and without symptoms — and most lack a recommended screening test. The Galleri test screens for screens for a signal shared by more than 50 cancers. These include the 12 deadliest cancers responsible for approximately two-thirds of cancer deaths, according to the American Cancer Society.1,5
These cancers are known to release more DNA fragments into the bloodstream at early stages before symptoms appear.
The Galleri test identifies DNA in the bloodstream shed by cancer cells and does not predict future genetic risk for cancer.
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.
For healthcare providers
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 Sep;32(9):1167-77. doi: 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/S0140-6736(23)01700-2
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
US Preventive Services Task Force. A,B,C grade recommendations, cancer, screenings. [cited 2023 Oct 23]. https://www.uspreventiveservicestaskforce.org/uspstf/topic_search_results
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]
Hackshaw A, Cohen SS, Reichert H, et al. Estimating the population health impact of a multi-cancer early detection genomic blood test to complement existing screening in the US and UK. Br J Cancer. 2021;125(10):1432-1442. doi: 10.1038/s41416-021-01498-4.