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 Galleri test is a qualitative, next-generation sequencing-based, in vitro diagnostic test intended for the detection of DNA methylation patterns using cell-free DNA isolated from human peripheral whole blood. DNA methylation is a natural process used by cells to regulate gene expression. 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.
The price for the Galleri test is $1695.00.