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
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 daysfrom the time the sample arrives at GRAIL’s laboratory.
The Galleri test provides two types of results
+ Top Predicted Cancer Signal Origin(s)
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
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- 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.
- 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).
- 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.
- With Galleri, annual screening provides the opportunity to detect more cancers early.
- Kulis M, Esteller M. DNA methylation and cancer. Adv Genet. 2010;70:27 – 56.