Introducing the Galleri® test
Unlock the potential of multi-cancer early detection
Galleri is a multi-cancer early detection (MCED) test that looks for a signal shared by more than 50 types of cancer1 through a simple blood draw. Most of these cancers have no recommended screening and often go unnoticed until symptoms appear. Adding the Galleri test to recommended cancer screening increases the chance of early cancer detection and may lead to successful treatment.2
Revolutionizing cancer screening
Age is the biggest risk factor for cancer. The risk of cancer increases exponentially after the age of 50. In fact, adults over age 50 are 13 times more likely to have cancer compared to people under the age of 50.3
Unfortunately, cancer can impact anyone. Approximately 90% of cancers are not hereditary.4
Routine cancer screening looks for only 5 cancer types - breast, colorectal, cervical, prostate, and lung.6 Many cancers are often found too late, when patients present with symptoms of late-stage disease, making prognosis poor and treatment more difficult.7
The earlier that cancer is diagnosed, the greater the chance of successful treatment and survival.8 Routine screening improves the chances of finding cancer in earlier stages when treatment may be more successful.7
Routine single-cancer screening tests, such as mammography and colonoscopy, save lives.9
However, an individual undergoing single-cancer screening, such as for colorectal cancer, is more likely to be diagnosed with a different cancer than the one being screened.10 Galleri goes further than routine cancer screenings to screen for more cancers, such as stomach and pancreatic cancer.1
Adding multi-cancer early detection gives healthcare providers a chance to screen for cancers that often remain asymptomatic until it is too late to meaningfully intervene.1
Advanced pattern-recognition of a unique cancer signal in the blood
Galleri leverages state-of-the-art DNA sequencing technology, in combination with pattern recognition, to screen for the presence of a cancer signal and localize its most likely origin.1,11
All cells, non-cancer and cancer, release DNA fragments, known as cell-free DNA (cfDNA), into the blood. Certain cfDNA methylation patterns are associated with cancer and can be considered a cancer signal. DNA methylation is a process used by cells to regulate gene expression. In cfDNA from cancer, certain regions of DNA are often hypermethylated or hypomethylated and are associated with specific patterns. These abnormal methylation patterns and the resulting change in gene expression can contribute to cancer initiation and progression.11,12
Screening for multiple cancers with Galleri
Cancer Signal Detection
The Galleri test analyzes cfDNA fragments to detect abnormalities in methylation patterns that could indicate the presence of cancer.1
Galleri has been trained on the largest known methylation database to identify patterns common to many cancers. It checks over 1 million methylation sites covering >100,000 genomic regions in DNA11. The Galleri test applies machine learning and pattern-recognition to identify abnormal DNA methylation patterns and detect a cancer signal shared by more than 50 types of cancer.1
Cancer Signal Origin Prediction
cfDNA methylation patterns are not only cancer-specific, but also provide tissue type or organ origin information.11
If a cancer signal is detected, Galleri predicts the tissue type or organ associated with the cancer signal to help guide the next steps to diagnosis.1,2
When a cancer signal is detected, Galleri uses pattern-recognition to compare the patient’s cfDNA methylation pattern to the patterns of 21 possible Cancer Signal Origin (CSO) predictions. If the CSO prediction has a very strong match to the patient’s methylation pattern, then only one CSO prediction is reported. Otherwise, the two best CSO predictions are reported. Galleri’s ability to predict the Cancer Signal Origin can help healthcare providers select appropriate diagnostic tests and procedures when a cancer signal is detected.1,2
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.
Surveillance, Epidemiology, and End Results (SEER) Program (seer.cancer.gov) SEER*Stat Database Incidence - SEER Research Limited-Field Data, 21 Registries, Nov 2020 Sub (2000-2018) - Linked To County Attributes -Time Dependent (1990-2018) Income/Rurality, 1969-2019 Counties, National Cancer Institute, DCCPS, Surveillance Research Program, released April 2021, based on the November 2020 submission. Risk Factor Data on file: American Cancer Society Cancer Prevention Studies II/III.
NIH/National Cancer Institute. Genetic testing for inherited cancer susceptibility syndromes. Accessed 3Mar2023. https://www.cancer.gov/about-cancer/causes-prevention/genetics/genetic-testing-fact-sheet.
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.
US Preventive Services Task Force. A,B,C Grade Recommendations Cancer. https://www.uspreventiveservicestaskforce.org/uspstf/topic_search_results.
Siegel R, Miller K, Fuchs H, et al. Cancer statistics, 2022. CA Cancer J Clin. 2022;72:7-33. DOI: https://doi.org/10.3322/caac.21708.
Surveillance, Epidemiology, and End Results (SEER) Program (seer.cancer.gov) SEER*Stat Database: Incidence — SEER 18 Regs Research Data, Nov 2018 Submission. Includes persons aged 50 – 79 diagnosed 2006 – 2015 “Early/Localized” includes invasive localized tumors that have not spread beyond organ of origin, “Late/Metastasized” includes invasive cancers that have metastasized beyond the organ of origin to other parts of the body.
NIH/National Cancer Institute. Cancer Screening/Research. Accessed 3May2023. https://www.cancer.gov/about-cancer/screening/research/what-screening-statistics-mean.
Clarke CA, Hubbell E, Ofman JJ. Multi-cancer early detection: a new paradigm for reducing cancer-specific and all-cause mortality. Cancer Cell. 2021;39(4):447-448. DOI: https://doi.org/10.1016/j.ccell.2021.02.004.
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;31(6):745-759. DOI: https://doi.org/10.1016/j.annonc.2020.02.011.
Wajed S, Laird P, DeMeester T. DNA Methylation: An alternative Pathway to Cancer. Ann Surgery. 2001;234(1):10-20. DOI: https://doi.org/10.1097/00000658-200107000-00003.