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
The Galleri test provides two types of results
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.
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
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
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.