Galleri

Multi-Cancer Early Detection Test

Multi-cancer early detection through a simple blood draw

The Galleri test provides:

Early cancer detection

The Galleri test detects many cancers that do not have routine screening tests, helping you protect your patients’ health.2,3

Simple implementation

Requiring only a single blood draw, the Galleri test offers a convenient way to get screened for cancer signals.

Broad and actionable

The Galleri test detects over 50 types of cancer and predicts the origin of the cancer signal with high accuracy to guide to next steps.3

Actionable results and next steps

The Galleri test detects abnormalities in the methylation patterns of cell-free DNA (cfDNA) that could indicate the presence of cancer.
When a cancer signal is detected, the test identifies the origin of the signal with high accuracy to help guide the next steps to diagnosis. Test results should be available to the ordering healthcare provider within 10 business days from the time the sample arrives at GRAIL’s laboratory.

The Galleri test provides two types of results

Cancer Signal Not Detected
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The Galleri test does not detect all cancers and not all cancers can be detected in the blood. The result of Cancer Signal Not Detected” does not rule out cancer.
Continue routine recommended screening + annual Galleri testing4
Cancer Signal Detected
+ Top Predicted Cancer Signal Origin(s)
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A test result of Cancer Signal Detected” must be confirmed by diagnostic tests in accordance with standard medical practice.
Diagnostic testing
This could mean that the individual has a cancer that was not identified by the selected follow-up diagnostic procedures, or that the result of the Galleri test is a false positive and that the individual does not have cancer.
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Next steps based on healthcare provider’s independent medical judgment.
Cancer confirmed: refer to cancer care

In the event that a diagnostic evaluation after a Cancer Signal Detected” result with the Galleri test does not confirm cancer, patients may be eligible for a complimentary retest with the Galleri test.

The request for a retest must be placed by the healthcare provider managing the patient’s diagnostic evaluation. The retest must be administered within 3 – 6 months after the initial Galleri test. To initiate a request for a retest, the healthcare provider should contact their GRAIL representative or contact GRAIL Customer Service.

A breakthrough innovation for early cancer detection

The Galleri test uses next-generation sequencing (NGS) and machine-learning algorithms to analyze methylation patterns of cell-free DNA (cfDNA) in the bloodstream.1

All cells — cancer and non-cancer — shed DNA into the bloodstream. cfDNA can carry cancer-specific information in its methylation patterns. DNA methylation is a process used by cells to regulate gene expression.5

The significance of methylation patterns 

In cancer, abnormal methylation patterns and the resulting changes in gene expression can contribute to tumor growth.5 Therefore, certain DNA methylation patterns can serve as a signal of cancer and provide information about the cancer signal’s origin. Through its proprietary methylation technology, the Galleri test can detect the presence of more than 50 types of cancer and predict the origin of the cancer signal with high accuracy.2,3

4 2 biology illustration image

Important safety information

The Galleri test does not detect all cancers and should be used in addition to routine cancer screening tests. Results should be interpreted by a healthcare provider. A Cancer Signal Not Detected” result does not rule out cancer. A Cancer Signal Detected” result requires confirmatory diagnostic evaluation (e.g. imaging), and if cancer is not confirmed, it may not be present, may not be detectable by diagnostic follow-up testing or may be located in a different part of the body. False-positive and false-negative test results do occur. Rx only.

Laboratory / test information

The GRAIL laboratory is CLIA-certified and CAP-accredited. The Galleri test was developed, and its performance characteristics were determined by GRAIL. The Galleri test has not been cleared or approved by FDA. The GRAIL laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is for clinical purposes. 

  1. Liu MC, Oxnard GR, Klein EA, et al.; CCGA Consortium. Sensitive and specific multi-cancer detection and localization using methylation signatures in cell-free DNA. Ann Oncol. 2020;31(6):745 – 59.
  2. The Galleri test does not detect all cancers and should be used in addition to, and not instead of, routine cancer screening tests recommended by clinical guideline organizations such as the American Cancer Society or the US Preventive Services Task Force (USPSTF).
  3. Klein E, et al. Clinical validation of a targeted methylation·based multi-cancer early detection test. Oral presentation at: American Association for Cancer Research; April, 2021; LB013.
  4. With Galleri, annual screening provides the opportunity to detect more cancers early.
  5. Kulis M, Esteller M. DNA methylation and cancer. Adv Genet. 2010;70:27 – 56
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