A new era of cancer screening is here with Galleri®1
Breakthrough test performance with a clinically-validated blood test. Galleri is supported by clinical studies with over 20,000 participants.1,2
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
Detection of a signal shared by multiple types of cancer with a single blood test2
Galleri screens for a signal shared by more than 50 cancer types with a single blood test, most of which lack recommended screening tests.1,3 In a clinical study, Galleri approximately doubled the number of cancers detected with recommended screening.2 Galleri goes beyond routine cancer screenings (breast, lung - for those at risk, colon, cervical, and prostate) to screen for additional cancers, such as stomach and pancreatic.1,3
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.
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 0.5% false positive rate, meaning 1 in 200 people who do not have cancer will receive a "Cancer Signal Detected" result.1,2 This helps minimize the chances that an individual without cancer receives a "Cancer Signal Detected" result, and therefore can help minimize unnecessary diagnostic procedures to confirm cancer.
False positive and false negative results do occur.
Highly accurate prediction of the tissue type or organ associated with the cancer signal
The predicted Cancer Signal Origin (CSO) helps guide next steps to confirm cancer. With a Cancer Signal Detected result, Galleri predicts one or two Cancer Signal Origins. This prediction offers information about the tissue type or organ associated with the cancer signal. There are 21 possible Cancer Signal Origins. In patients with a confirmed cancer diagnosis following a Galleri Cancer Signal Detected result, the test was accurate 88% of the time in predicting the first or second Cancer Signal Origin.2 If the predicted Cancer Signal Origin does not result in a cancer diagnosis it could mean the cancer could not be detected or is in another location.
Detects a signal shared by deadly cancers that lack recommended screenings
These deadly cancers tend to release more cell-free DNA into the bloodstream at early stages, are responsible for two-thirds of cancer deaths, and are more likely to be detected by the Galleri test.1,4
The Galleri test looks for a signal associated with active cancer and does not predict future genetic risk for cancer.
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.
GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists (CAP). 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.
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, 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.
US Preventive Services Task Force. Recommendations Cancer. Accessed 7Mar2023. https://www.uspreventiveservicestaskforce.org/uspstf/topic_search_results.
American Cancer Society. Cancer Facts & Figures 2022. Atlanta: American Cancer Society; 2022 https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2022.html. Data on file GA-2021-0065.