Multi-cancer early detection test

The earlier that cancer can be found, the higher the chance of successful treatment and survival. Yet, too often cancer goes undetected until it has progressed to an advanced stage.

In studies, the Galleri test has shown the ability to detect multiple cancers through a simple blood draw. Most of these cancers cannot be detected through current screening paradigms. When cancer was detected, the Galleri test localized the cancer signal with high accuracy, helping inform next steps to diagnosis.1

The Galleri test is intended to be complementary to, and not a replacement of, U.S. guideline-recommended cancer screening.

For more information, visit www.galleri.com.

 

Important Safety Information

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. 

Results should be interpreted by a healthcare 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 

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.

Galleri is a trademark of GRAIL, Inc.
1. Liu MC, et al. Ann Oncol. 2020; 31(6):745-759. DOI:10.1016/j.annonc.2020.02.011