Help attract patients and improve cancer screening adherence*
†If the Galleri test was offered at the same time and location as their
preventive cancer screening tests.
‡If forced to find a new PCP (i.e., due to moving).
*Among those currently non compliant with at least one cancer screening, n=261.
**Galleri Health System Patient Survey market research, data on file 2021. Study demographics included 1,001 respondents, age 50+, including high-risk individuals age 35 – 49 (n=150). Respondents had private or commercial health insurance, Medicare, or government insurance coverage and had visited a PCP in the past two years.
Learn how Galleri can advance your health system and help your patients
Multi-cancer early detection through a simple blood draw
Early cancer detection
Detects 50+ cancer types, many of which do not have screening tests.2§§
Testing with ease
Can be easily incorporated into a routine healthcare visit.
If a cancer signal is found, predicts where in the body the cancer is located with 89% accuracy.2
Adrenal Cortical Carcinoma
Ampulla of Vater
Bile Ducts, Distal
Bile Ducts, Intrahepatic
Bile Ducts, Perihilar
Colon and Rectum
Esophagus and Esophagogastric Junction
Gastrointestinal Stromal Tumor
Gestational Trophoblastic Neoplasms
Lymphoma (Hodgkin and Non-Hodgkin)
Melanoma of the Skin
Mesothelioma, Malignant Pleural
Merkel Cell Carcinoma
Nasal Cavity and Paranasal Sinuses
Neuroendocrine Tumors of the Appendix
Neuroendocrine Tumors of the Colon and Rectum
Neuroendocrine Tumors of the Pancreas
Oropharynx (HPV-Mediated, p16+)
Oropharynx (p16-) and Hypopharynx
Ovary, Fallopian Tube and Primary Peritoneum
Plasma Cell Myeloma and Plasma Cell Disorders
Soft Tissue Sarcoma of the Abdomen and Thoracic Visceral Organs
Soft Tissue Sarcoma of the Head and Neck
Soft Tissue Sarcoma of the Retroperitoneum
Soft Tissue Sarcoma of the Trunk and Extremities
Soft Tissue Sarcoma Unusual Histologies and Sites
Uterus, Carcinoma and Carcinosarcoma
Ureter (and Renal Pelvis)
FAQs for the Galleri test
The Galleri test may be offered to healthcare system employees, primary care practices, high-risk clinics, or as part of an executive benefits package. The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older. It is intended to be used in addition to, and not replace, other cancer screening tests a healthcare provider orders.
The Galleri test is being used by the Mayo Clinic, M Health Fairview, and the Providence health system at its California, Washington, and Oregon points-of-care locations. The test is being rolled out by additional healthcare systems on an ongoing basis.
The Galleri test is a qualitative, next-generation sequencing-based, in vitro diagnostic test intended for the detection of DNA methylation patterns using cell-free DNA (cfDNA) isolated from human peripheral whole blood. DNA methylation is a natural process used by cells to regulate gene expression. Certain DNA methylation patterns can serve as a signal of cancer and, if found, using pattern recognition, the Galleri test can predict the cancer signal origin.
The Galleri test looks for signals present in the blood that may be associated with cancer at the time of your blood draw. If a cancer signal is detected, Galleri results can point to where in the body the cancer is coming from to help the healthcare provider guide next steps.
The Galleri test detects methylation patterns of cell-free DNA (cfDNA) that could indicate the presence of cancer. When a cancer signal is detected, the test predicts the origin of the cancer signal with high accuracy. The Galleri test does not detect specific genetic mutations and does not determine an individual’s genetic risk for cancer.
Galleri is recommended for adult patients with an elevated risk of cancer, such as those aged 50 or older. The Galleri test should be used in addition to guideline-recommended cancer screening, such as mammography, colonoscopy, prostate-specific antigen (PSA), or cervical cancer screening.
The Galleri test is not intended to replace guideline-recommended cancer screening tests. One of the most pressing unmet needs in early cancer detection is to identify cancers for which there are no existing recommended screening tests. Galleri is designed to detect many cancer types, including those that lack routine screenings. The United States Preventive Services Task Force (USPSTF) currently recommends screening paradigms for lung (for high-risk smokers), breast, cervical, prostate, and colorectal cancers.
Using the Galleri test alongside existing cancer screening programs, such as mammograms and colonoscopies, is expected to increase the chance of early cancer detection. In addition to detecting many cancers that lack recommended screenings, the Galleri test may also find cancers missed during routine screening, cancers in individuals who were non-adherent to current cancer screening tests, cancers that occurred during screening intervals, or cancers that occurred in individuals who lack access to existing screening tests.2
Important Safety Information
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.
Laboratory / test information
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.
Learn how Galleri can help your patients
- Surveillance, Epidemiology, and End Results (SEER) 18 Regs Research Data, Nov 2017 Submission. Includes persons aged 50 – 79. Sensitivity and specificity from Liu MC, et al. Ann Oncol. 2020;31(6):745 – 759; doi: 10.1016/j.
- 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 – 1177. doi: 10.1016/j.annonc.2021.05.806.
- Amin MB, Edge S, Greene F, et al. (Eds.). AJCC Cancer Staging Manual (8th edition). Springer International Publishing: American Joint Commission on Cancer; 2017