What cancers does Galleri® screen for?

See the list of cancers diagnosed after a Galleri Cancer Signal Detected result:

Types of cancer detected
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
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How does the test work?

All cells in your body, including cancer cells, release DNA fragments into the bloodstream when they complete their life cycle and die. These fragments are known as cell-free DNA.1 The Galleri test screens your blood sample for cell-free DNA and identifies whether it comes from healthy or cancer cells.2

DNA from cancer cells has specific methylation patterns that identify it as a cancer signal. Methylation is a natural process that can change the activity of DNA. Methylation patterns also contain information about the tissue type or organ associated with the cancer signal.3

illustrated video poster of the Galleri test sitting on a table in an examination room with an anatomy poster on the wall behind it

Galleri looks for a signal associated with cancer

Through a blood sample, Galleri looks for a signal associated with active cancer. Every time you take the test, Galleri checks more than 100,000 DNA regions and over a million specific DNA sites to screen for a signal shared by 50+ cancers at the time of your blood draw.3 If a cancer signal is detected, results from the test can predict the tissue type or organ associated with the cancer signal.2

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 it doesn’t determine your future risk of developing cancer.2,4

illustration of a pink strand of DNA on a blue background

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

Galleri looks for a cancer signal shared by more than 50 cancer types.2 You will not receive a list of the 50+ types of cancer and a result for each one.

If Galleri detects a cancer signal, your result will include one or two Cancer Signal Origins which predict the tissue type or organ associated with the cancer signal.

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.

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

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

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.

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.

  1. Thierry A, El Messaoudi S, Gahan P, et al. Origins, structures, and functions of circulating DNA in oncology. Cancer Metastasis Rev. 2016;35:347–76. DOI: https://doi.org/10.1007/s10555-016-9629-x.

  2. 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.

  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. 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.