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The Galleri test is a qualitative, sequencing-based, in vitro diagnostic test used to detect DNA methylation patterns using cell-free DNA isolated from human peripheral whole blood. Certain DNA methylation patterns can serve as a signal of cancer and provide information about the origin of the cancer signal.
The Galleri test should be used in addition to guideline-recommended cancer screening, such as mammography, colonoscopy, prostate specific antigen (PSA) or cervical cancer screening. Galleri can benefit patients with an elevated risk of cancer due to age, such as those aged 50 or older.
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. 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 the tissue type or organ associated with the cancer signal to help your healthcare provider determine next steps.
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