Breakthrough test performance

Galleri® is a clinically validated cancer screening test designed to allow you to see the previously undetectable


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.

waist up studio portrait of a woman in blue t-shirt with gray hair wearing a stethoscope gazing off camera

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.

Advancing cancer screening with a clinically-validated blood test1,2

The Galleri test is supported by clinical studies with over 20,000 participants1,3,4

Lancet: A prospective study of a multi-cancer early detection (MCED) blood test2

  • Cohort: 6,600+ adults ages 50-79 without clinical suspicion of cancer, and with and without additional cancer risk factors from 7 US sites—intended use population
  • Study design: Prospective, interventional, return-of-results study to evaluate the clinical implementation of an MCED test.
  • Study objectives: Assess the extent of diagnostic testing required to achieve diagnostic resolution, evaluate test performance, and evaluate participant reported outcomes.
  • Key outcomes: When MCED was added to recommended single-cancer screening tests the number of cancers detected approximately doubled. Median time to diagnostic resolution was 79 days (shorter for true positive; longer for false positive). High accuracy of predicted Cancer Signal Origin enabled targeted diagnostic evaluations. Most diagnostic evaluations involved imaging. Key performance metrics were validated and MCED screening was safely implemented. The results from the PATHFINDER study support feasibility of broad screening use of Galleri.
Review the PATHFINDER study

Annals of Oncology: Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set1

  • Cohort: 4,000+ participants without a prior history of cancer from 142 sites, 70% with newly diagnosed cancer, 30% cancer free at enrollment and at 1 year.
  • Study design: Case-controlled observational study to validate an MCED test regarding sensitivity, specificity and Cancer Signal Origin prediction.
  • Study objectives: Validate an MCED test version further refined for use as a screening tool.
  • Key outcomes: The Galleri test demonstrated high specificity with a low false positive rate, sensitivity that varied by cancer class and increased with increasing cancer stage, high accuracy of CSO prediction and detected a cancer signal across a wide diversity of cancers and cancer stages. Results from the CCGA3 study support the feasibility of use in addition to recommended single-cancer screening tests. 
Review the CCGA3 study

Galleri sets the standard for multi-cancer early detection

To achieve the benefits of early detection while minimizing harms, multi-cancer early detection requires low false positive rates, highly accurate localization of organ/tissue origin, and high sensitivity of the deadliest cancer types.5

close up image of the Galleri test box with a female physician out of focus in the background

Screen for more

Galleri detects a signal shared by more than 50 cancer types1 with a single blood draw, most of which lack routine screening tests. In a clinical study, Galleri approximately doubled the number of cancers detected than recommended screening.2 In the same study, 48% of confirmed cancers that were detected by Galleri were in stages I-II.2 The Galleri goes beyond routine cancer screenings (breast, lung, colon, cervical, and prostate) to screen for many cancers.

Multi cancer early version 2

99.5% Specificity1,2

Galleri has a specificity of 99.5%, which means that it has a low false positive rate of 0.5%. A low false positive rate helps minimize unnecessary diagnostic procedures.

Specificity = The proportion of people without cancer who received "No Cancer Signal Detected" results.

43.1% Positive Predictive Value2

The Galleri’s positive predictive value (PPV) is 43.1%, meaning that about 4 out of 10 individuals with a Cancer Signal Detected result are expected to have a confirmed cancer diagnosis following diagnostic workup. Galleri’s PPV helps healthcare providers set expectations when discussing appropriate next steps for diagnostic workup.

Learn more about the Galleri test's PPV

Positive Predictive Value = The proportion of people with Cancer Signal Detected results diagnosed with cancer

98.5% Negative Predictive Value2

The negative predictive value (NPV) for Galleri is 98.5%, which provides confidence that a No Cancer Signal Detected result is likely a true negative.

 

Negative Predictive Value = The proportion of people with No Cancer Signal Detected results without cancer.

93.4% Cancer Signal Origin Accuracy6

The Galleri test’s highly accurate Cancer Signal Origin (CSO) prediction is an essential feature of multi-cancer early detection test. It helps clinicians effectively direct a diagnostic evaluation after a Cancer Signal Detection result.1,2

Cancer Signal Origin Accuracy = The proportion of correctly predicted first (or second) CSO prediction(s) among study participants with cancer and "Cancer Signal Detected" results.

Galleri Test has 18 possible Cancer Signal Origin Predictions1

CSO Reported What Is Included
Anus Anus
Bladder, Urothelial Tract Bladder, Renal Pelvis, Urether, Urethra
Bone and Soft Tissue

Skeletal Muscle and other Connective Tissue, Vascular Tissue, Bone and Cartilage
Cervix Cervix

Colon, Rectum

 Colon, Rectum, Appendix
Head and Neck

Oropharynx, Hypopharynx, Nasopharynx, Larynx, Lip and Oral Cavity (including Oral Tongue), Nasal Cavity, Paranasal Sinuses, Major Salivary Glands

Hematopoietic and Lymphoid Organs 

Bone Marrow, Primary and Secondary Lymphoid Tissue (Lymph Nodes, Extranodal Lymphoid Tissue, Spleen, Thymus) 

Kidney (excluding renal pelvis)

 Kidney
Liver, Bile Duct

Liver, Intrahepatic Bile Duct
Lung Lung, Bronchus

Melanocyte-containing Tissues/ Skin

Melanocyte-containing Tissues (Skin, Uvea and Muscosal Tissue) 
Ovary

Ovary, Fallopian Tube, Primary Peritoneum
Pancreas, Gallbladder

Pancreas, Extrahepatic Bile Duct, Gallbladder
Prostate Prostate
Stomach, Esophagus Stomach, Esophagus

Thyroid

Thyroid
Uterus Uterus

76.3% sensitivity for 12 deadly cancers1

Galleri has high sensitivity (76.3%) for 12 of the deadliest cancers* that comprise two-thirds of all cancer deaths.1,7 Higher sensitivity for the deadliest cancers helps minimize overdiagnosis and/or overtreatment of indolent cancers.1 More aggressive cancers, such as pancreatic cancer, tend to release more cell-free DNA into the bloodstream at early stages and are more likely to be detected by the Galleri test.1,3 The overall sensitivity for cancer detection is 51.5% for all cancers and across all stages. This provides the opportunity to detect many additional cancers when added to recommended single-cancer screening.


Sensitivity = The proportion of people with cancer who received "Cancer Signal Detected" results.

*Anus, bladder, colon/rectum, esophagus, head and neck, liver/ bile duct, lung, lymphoma, ovary, pancreas, plasma cell neoplasm, and stomach

Cancer Classes Sensitivity, proportion of true positives
Liver/Bile-duct
Head and Neck
Esophagus
Pancreas
Ovary
Colon/Rectum
Anus
Cervix
Urothelial Tract
Lung
Plasma Cell Neoplasm
Gallbladder
Stomach
Sarcoma
Lymphoma
Other
Melanoma
Lymphoid Leukemia
Bladder
Breast
Uterus
Myeloid Neoplasm
Kidney
Prostate
Thyroid

See publications supporting Galleri test performance

Review published data

Ongoing clinical evidence program backed by 380,000+ participants

The GRAIL clinical evidence program includes more than 380,000 participants in completed or ongoing studies. To support and validate our technology, studies are being performed at leading health systems and community and academic medical centers in the US and United Kingdom.

Learn More
image depicting the logos of the network of insititutions who have participated or are participating in clinical studies of the Galleri test

Real world experience with over 200,000 Galleri tests completed

.9%

 

of test results were Cancer Signal Detected, consistent with clinical studies2,8

68%

 

of Cancer Signal Detected results had predicted Cancer Signal Origins representing cancers without guideline-recommended screening options8,9

Hear from Galleri patients and providers

Hear their stories

The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those age 50 or older. The test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. The Galleri test is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of the test 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.

  1. 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.
  2. 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 
  3. 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.
  4. Jamshidi A et al Cancer cell 2022
  5. Hackshaw A, Clarke CA, Hartman AR. New genomic technologies for multi-cancer early detection: Rethinking the scope of cancer screening. Cancer Cell. 2022;40(2):109-113. DOI: https://doi.org/10.1016/j.ccell.2022.01.012.
  6. GRAIL, Inc. Data on file: VV-TMF-59592
  7. 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. GRAIL, Inc. Data on file GA-2021-0065.
  8. GRAIL, Inc. Data on File: GA-2022-0078.
  9. US Preventive Services Task Force. Recommended cancer screening tests, Grade A,B,C. [cited 2023 Oct 23]. https://www.uspreventiveservicestaskforce.org/uspstf/topic_search_results