Multi-Cancer Early Detection Through a Simple Blood Test
A multi-cancer early detection blood test works by analyzing fragments of DNA circulating in the bloodstream that may be released by cancer cells. The test is designed to identify signals associated with the presence of existing cancers at the time of testing.
It does not evaluate inherited genetic risk or predict the likelihood of developing cancer in the future, and should be used as a complement to routine, provider-recommended cancer screenings.
What is a Multi-Cancer Blood Test ?
A multi-cancer blood test is designed to help identify signals associated with multiple types of cancer through a single blood draw.
The test analyzes fragments of DNA that may be shed into the bloodstream by cancer cells and looks for patterns that suggest the presence of cancer.
The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those age 50 or older. The test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. The Galleri test is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of the test 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.
The GRAIL clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. 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. The GRAIL clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes
Important to note
The Galleri® test does not detect signals for every type of cancer, and not all cancers can be identified through a blood sample. False-positive and false-negative results are possible. This test is intended to complement—not replace—standard, healthcare provider-recommended cancer screening tests.
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