The Galleri® Multi-Cancer Early Detection (MCED) test is a new cancer screening test that can detect a shared cancer signal across 50 types of cancer through a simple blood sample. The new MCED test can detect types of cancers that currently have no recommended screening tests. It can also alert you to hard-to-detect, aggressive and often fatal types of cancer like pancreatic, ovarian and esophageal cancers.
The MCED test, which should be used together with U.S. guideline-recommended annual cancer screenings, looks for signals in the bloodstream that may be linked to cancer. If a cancer signal is detected, the test can often pinpoint its origin in the body to help the care team develop the next steps for treatment or additional diagnostic testing.
The MCED test detects signals for 50 types of cancer
A simple blood sample with results in about two weeks
Can often pinpoint where the cancer signal comes from
The MCED test is recommended for adults with an elevated risk for cancer, such as those aged 50 or older. This new blood test should be used in addition to, not in place of, other cancer-screening tests recommended by your health care provider.
The MCED test does not detect all cancers, nor does it measure your genetic risk of developing cancer in the future.
Mercy has reviewed the risk factors that increase a person's chance to develop cancer. Find out if you might benefit from the MCED test:
The MCED 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 health care provider. This test is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of this 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 health care provider in the context of medical history, clinical signs and symptoms. A test result of “Cancer Signal Not 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.
Laboratory / Test Information
The MCED test clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. The test was developed, and its performance characteristics were determined by GRAIL. The test has not been cleared or approved by the Food and Drug Administration. The clinical laboratory is regulated under CLIA to perform high-complexity testing. This test is intended for clinical purposes.
Galleri® is a registered trademark of GRAIL, LLC, and is manufactured by GRAIL.
The vast majority of cancers show no symptoms until later stages, when treatment options may be limited. The Multi-Cancer Early Detection test searches for over 50 types of cancer, many of which are hard to detect and not commonly screened for.