The Galleri test screens for multiple cancers

The Galleri test does not detect a signal for all cancers and not all cancers can be detected in the blood.

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The Galleri test does not detect a signal for all cancers and not all cancers can be detected in the blood.

The Galleri test screens for a signal shared by 50+ types of cancer2:

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

How does the Galleri test work?

Cancers growing in the body shed DNA into the bloodstream.1,2,3 Although there are many types of cancer, the DNA fragments can act like a unique “fingerprint” of cancer. The Galleri test screens for many of the deadliest cancers before they become symptomatic, including those without recommended screening tests.1,4 The test results provide a predicted Cancer Signal Origin* to help your healthcare provider determine the next steps for diagnosis.5

Learn more about the science behind Galleri

*In the PATHFINDER study, Cancer Signal Origin (CSO) prediction accuracy was 88% for participants with a cancer diagnosis among study participants with Cancer Signal Detected test result.

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Screen for cancer before symptoms appear

Every time you take the test, Galleri screens more than 100,000 DNA regions and over 1 million specific DNA sites2 to screen for many of the deadliest cancers before they become symptomatic.1,2,5 Cancer can develop at any time. Galleri is a test that identifies DNA in the bloodstream shed by cancer cells and screens for signal shared by multiple cancers at time of testing.

Galleri is a screening test and does not diagnose cancer. Diagnostic testing is needed to confirm cancer. The Galleri test is not a genetic risk assessment and does not predict future genetic risk for cancer.

illustrated graphic video explaining how the Galleri test works

Understanding your results

You will receive your test result about two weeks after your blood sample is received at the GRAIL lab.

There are two possible results:

— No Cancer Signal Detected
— Cancer Signal Detected

Nearly 99% of people who use the Galleri test will screen negative — which is exactly what you want to hear.5 Continue with routine cancer screening tests your healthcare provider recommends.

If a cancer signal is found, results also can predict the tissue type or organ associated with the cancer signal. This vital information can help guide your healthcare provider with the next steps.5


Learn more about test results

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. Galleri is a screening test and does not diagnose cancer. Diagnostic testing is needed to confirm cancer.


pink square graphic with an exclamation mark icon in the upper right corner with the text "cancer signal detected" in the bottom left corner, overlapping a blue square graphic with a check mark icon in the upper right corner with the test "no cancer signal detected" in the bottom left corner

Get started with the Galleri® test

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Patients

Patients

I am interested in learning more about the Galleri test

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Healthcare Providers

Healthcare Providers

I am a healthcare provider interested in offering the Galleri test to my patients

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Employers

Employers

I represent an employer interested in offering the Galleri test to my organization’s employees

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Health Systems

Health Systems

I represent a health system interested in making the Galleri test available to my patient population

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.

  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 Sep;32(9):1167-77. doi: 10.1016/j.annonc.2021.05.806

  2. 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 Mar 30;31(6):745-59. doi: 10.1016/j.annonc.2020.02.011

  3. Thierry AR, El Messaoudi S, Gahan PB, et al. Origins, structures, and functions of circulating DNA in oncology. Cancer Metastasis Rev. 2016 Jul 8;35:347–76. doi: 10.1007/s10555-016-9629-x

  4. US Preventive Services Task Force. A,B,C grade recommendations, cancer, screenings. [cited 2023 Oct 23]. https://www.uspreventiveservicestaskforce.org/uspstf/topic_search_results

  5. 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