Patient Stories
Real life, personal experiences that offer a glimpse into the impact of multi-cancer early detection
Darla, Pancreatic Cancer
Darla accepted her insurance company’s offer to take the Galleri test, which yielded a Cancer Signal Detected result with a Cancer Signal Origin pancreas, despite experiencing no symptoms.
Kevin, Esophageal Cancer
Kevin, a healthy, fit firefighter of 30 years, took the Galleri test when it was offered as a proactive measure by his fire department.
Valerie, Gallbladder Cancer
In an effort to stay on top of her health, Valerie took the Galleri test and was shocked to receive a Cancer Signal Detected result with a Cancer Signal Origin of gallbladder.
Jack, Head and Neck Cancer
Jack’s family did not have a history of cancer, while his wife’s did – so neither thought he was likely to receive a Cancer Signal Detected result from the Galleri test.
Roger, Pancreatic Cancer
Pancreatic cancer was Roger’s worst fear, but ultimately he felt fortunate it was detected as early as it was.
The Galleri test does not detect a signal for all cancers, and not all cancers can be detected in the blood. False-positive and false-negative results do occur. Galleri is a screening test and does not diagnose cancer. Diagnostic testing is needed to confirm cancer. The Galleri test should be used in addition to healthcare provider recommended screening tests.
Based on a clinical study of people ages 50 to 79 around 1% are expected to receive a cancer signal detected result which includes predicted cancer signal origins. After diagnostic evaluation, around 40% of these people are expected to have a confirmed cancer diagnosis.
The overall sensitivity in study participants with esophageal cancer was 85.0% (12.5% for stage I, 64.7% stage II, 94.1% stage III, 100% stage IV).
The overall sensitivity in study participants with gallbladder cancer was 70.6% (0% for stage I, 33.3% stage II, 75.0% stage III, 100% stage IV).
The overall sensitivity in study participants with head and neck cancer was 85.7% (63.2% for stage I, 82.4% stage II, 84.2% stage III, 96.0% stage IV).
The overall sensitivity in study participants with pancreatic cancer was 83.7% (61.9% for stage I, 60.0% stage II, 85.7% stage III, 95.9% stage IV).
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 “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.
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 U.S. 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.
