Licensing & Locations
Menlo Park (MPK)
1525 O’Brien Dr
Menlo Park, CA 94025
CLIA Certificate of Accreditation: 05D2154430
The College of American Pathologists (CAP): 8149563
California Department of Public Health: CDF-00352665
Maryland Department of Health Permit: 3204
Rhode Island Department of Health License: LCO01503
New York State Department of Health Permit: PFI-9558
Pennsylvania Department of Health Permit: 38399
Research Triangle (RTP)
4001 E NC 54 Hwy Assembly Suite 1100
Durham, NC 27709
CLIA Certificate of Accreditation: 34D2231294
The College of American Pathologists (CAP): 9151388
California Department of Public Health: CDS-90007074
Maryland Department of Health Permit: 3526
Rhode Island Department of Health License: LCO01562
New York State Department of Health Permit: PFI-9711
Pennsylvania Department of Health Permit: 39687
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 where in the body the cancer signal is located. Use of Galleri is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment.
Results should be interpreted by a healthcare provider in the context of medical history, clinical signs and symptoms. A test result of “No Cancer Signal Detected” does not rule out cancer. A test result of “Cancer Signal Detected” requires confirmatory diagnostic evaluation by medically established procedures (e.g. imaging) to confirm cancer.
If cancer is not confirmed with further testing, it could mean that cancer is not present or testing was insufficient to detect cancer, including due to the cancer being located in a different part of the body. False-positive (a cancer signal detected when cancer is not present) and false-negative (a cancer signal not detected when cancer is present) test results do occur. Rx only.
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.