The Galleri® test screens for many of the deadliest cancers before they become symptomatic.
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 should be used in addition to healthcare provider recommended screening tests.
Adding Galleri to your cancer screenings can increase your chance of finding cancer early. Galleri does not replace other screening tests your healthcare provider recommends.
Recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older. People without symptoms can take the test. Your healthcare provider can determine if the test is right for you.
The Galleri® test screens your blood sample (2 tubes of blood) and identifies DNA fragments shed into the blood by developing cancers
Although there are many types of cancer, these DNA fragments act like a unique “fingerprint” often associated with cancer.
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Through your healthcare provider; a prescription is required
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At your healthcare provider’s clinic or laboratory
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About 2 weeks after your blood sample is received at the GRAIL laboratory
Evaluated in a large clinical study, the Galleri test screened for a signal shared by 50+ types of cancer.
Included in the 50+ types of cancer are 12 aggressive cancers responsible for 2/3rds of cancer deaths. Aggressive cancers shed more DNA and are more likely to have a Cancer Signal Detected result.
Sensitivity varies by cancer type and stage. For more information visit: Galleri.com/test-report
There are two possible test results.
This result means DNA fragments associated with cancer were not found in the blood sample. The test does not detect all cancers and not all cancers can be detected in the blood. This result does not completely rule out the possibility of cancer.Based on a clinical study, people with this result were unlikely to have cancer. In fact, less than 2 out of 100 people with this result received a cancer diagnosis.
Next steps:
Continue with routine cancer screenings your healthcare provider recommends.
Adding Galleri to recommended screenings at your annual wellness visits can improve your chance of finding cancer early. Ask your healthcare provider when is best to test again.
This means DNA fragments often associated with cancer were
found in the blood sample. This result will also include a prediction of
the tissue type or organ associated with the cancer signal, called a
Cancer Signal Origin. Next steps: This result is not a cancer diagnosis
and requires follow-up diagnostic testing which may include lab work
or imaging ordered by your healthcare provider to confirm cancer.
Learn more about results:
Galleri.com/results
Most health insurance plans do not cover the cost of the Galleri test. You may be able to use pre-tax dollars in your flexible spending account (FSA) or health savings account (HSA) to pay for the Galleri test. Check with your FSA or HSA administrator or insurance provider to determine eligibility
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.
Laboratory/Test Information: The GRAIL clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. 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. The GRAIL clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes.
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