Galleri Early Cancer detection Test
Beating cancer starts with knowing you have it
Finding cancer early is important to improve treatment outcomes and survival.1
The vast majority of cancers show no symptoms until later stages, when treatment options may be limited. Today, many cancers are found too late, when outcomes are often deadly.
Finding cancer early is important
Thinking about the possibility of cancer can be overwhelming, but taking steps to find cancer early can help you feel more in control. Often, the earlier that cancer can be found, the higher the chance of better outcomes.1
The Galleri test can be included in a routine visit with your healthcare provider through a simple blood draw. Talk to your healthcare provider today about your risk for cancer, and whether the Galleri test is right for you.
The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older. It is intended to be used in addition to and not replace other cancer screening tests your healthcare provider recommends.
Not all cancers can be detected by the Galleri test. Your healthcare provider will discuss appropriate follow-up testing to confirm if cancer is present.
Based on a clinical study of people ages 50 to 79, around 1% received a Cancer Signal Detected result which included predicted Cancer Signal Origin(s). After diagnostic evaluation, around 40% of people received a confirmed cancer diagnosis (Positive Predictive Value, PPV).9
In another clinical study that included participants with newly diagnosed cancer, 51.5% of these participants received a Cancer Signal Detected result (sensitivity) and a predicted Cancer Signal Origin across 50 different cancer types. The predicted Cancer Signal Origin (cancer location) was accurate 88.7% of the time. The study also included participants without cancer, 0.5% of these participants received a Cancer Signal Detected result (false positive).7,8
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. 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. Rx only.