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 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.
How the Galleri test works
The Galleri test scans a blood sample for a cancer-specific signal found on cell-free DNA (cfDNA). If detected, Galleri localizes the origin of the cancer signal with high accuracy.5
Galleri is a screening test and does not diagnose cancer. Diagnostic testing is needed to confirm cancer. Galleri should be used in addition to healthcare provider recommended screening tests
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50+ cancer types
The Galleri test detects a signal shared by 50+ cancer types. In clinical studies, the following cancers were diagnosed after a Cancer Signal Detected result with the Galleri test.1
A
- Adrenal Cortical Carcinoma
- Ampulla of Vater
- Anus
- Appendix, Carcinoma
B
- Bile Ducts, Distal
- Bile Ducts, Intrahepatic
- Bile Ducts, Perihilar
- Bladder, Urinary
- Bone
- Breast
C
- Cervix
- Colon and Rectum
E
- Esophagus and Esophagogastric Junction
G
- Gallbladder
- Gastrointestinal Stromal Tumor
- Gestational Trophoblastic Neoplasms
K
- Kidney
L
- Larynx
- Leukemia
- Liver
- Lung
- Lymphoma (Hodgkin and Non-Hodgkin)
M
- Melanoma of the Skin
- Merkel Cell Carcinoma
- Mesothelioma, Malignant Pleural
N
- Nasal Cavity and Paranasal Sinuses Nasopharynx
- Neuroendocrine Tumors of the Appendix
- Neuroendocrine Tumors of the Colon and Rectum
- Neuroendocrine Tumors of the Pancreas
O
- Oral Cavity
- Oropharynx (HPV-Mediated, p16+)
- Oropharynx (p16-) and Hypopharynx
- Ovary, Fallopian Tube and Primary Peritoneum
P
- Pancreas, exocrine
- Penis
- Plasma Cell Myeloma and Plasma Cell Disorders
- Prostate
S
- Small Intestine
- 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
- Stomach
T
- Testis
U
- Ureter, Renal Pelvis
- Uterus, Carcinoma and Carcinosarcoma
- Uterus, Sarcoma
V
- Vagina
- Vulva
Galleri is a screening test and does not diagnose cancer. Diagnostic testing is needed to confirm cancer.
Supported by robust clinical data, Galleri sets the standard for multi-cancer early detection
20,000+ individuals participated in large clinical studies1,5
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Galleri is revolutionizing cancer screening1
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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;32(9):1167-77. DOI: https://doi.org/10.1016/j.annonc.2021.05.806.
American Cancer Society. Lifetime Risk of Developing or Dying From Cancer. https://www.cancer.org/cancer/risk-prevention/understanding-cancer-risk/lifetime-probability-of-developing-or-dying-from-cancer.html.
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.
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. https://grail.com/wp-content/uploads/2022/09/Schrag_903O_ESMO-2022_Pathfinder-Main_Proferred-Paper-Oral-Presentation.pdf.