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Galleri Multi-Cancer Early Detection Test
Introducing, the Galleri® test, a Multi-Cancer Early Detection blood test.
The Galleri® Multi-Cancer Early Detection (MCED) test is an innovative cancer screening tool that uses a simple blood sample to detect a common cancer indication present in 50 types of cancer. It is effective in identifying certain cancers that currently lack recommended screening methods. Furthermore, it has the capability to identify elusive, aggressive, and often fatal cancers such as pancreatic, ovarian, and esophageal cancers.
The MCED test is not intended to replace the recommended yearly cancer screenings in the United States, but rather to complement them. It looks for signals in the blood that may be associated with cancer. When it detects a cancer signal, the test can often pinpoint the cancer's source in the body, which can help the care team plan the next steps for either treatment or additional diagnostic testing.
The MCED test can detect a signal shared by many cancers before symptoms become obvious.
All we need is a blood sample, you will receive your results in as little as 2 weeks.
Your results will either say “No Cancer Signal Detected” or “Cancer Signal Detected".
The MCED test is recommended for adults at a higher risk for cancer, particularly people aged 50 or older. This new blood test is meant to add to, not replace, other cancer screening tests your healthcare provider suggests. It's important to know that the MCED test does not find all cancers and does not assess your genetic risk for developing cancer in the future.
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.
The GRAIL laboratory is CLIA-certified and CAP-accredited. The Galleri test was developed and its performance characteristics were determined by GRAIL. The Galleri test has not been cleared or approved by FDA. The GRAIL laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is for clinical purposes. Administration. GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes.
