Implementing Galleri® in your practice
GRAIL has resources and support to help providers integrate Galleri into their practices. The Galleri test only requires a simple blood draw, allowing integration into existing patient touchpoints such as annual health checks or routine blood work.
The Galleri test is recommended for use in adults with elevated cancer risk, such as those aged 50 or older. It should be used in addition to recommended cancer screenings. Use of Galleri is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment.
Receiving your patients' Galleri test results
Galleri test results will be released to the ordering healthcare provider about two weeks after a patient’s sample has been received at GRAIL’s laboratory. Healthcare providers can access test results via the Provider Portal and/or by fax. Provider Portal users will be able to set up email notifications when new results are ready.
Understanding Galleri test results
Sample Test Report:
A "No Cancer Signal Detected" test result indicates that the Galleri test did not detect DNA methylation patterns that are associated with cancer. A test result of "No Cancer Signal Detected" does not rule out cancer. In the PATHFINDER clinical study, on average, fewer than 2 out of 100 people with a "No Cancer Signal Detected" result received a cancer diagnosis (Negative Predictive Value or NPV was 98.5%).1 When patients receive a “No Cancer Signal Detected” result, continue with appropriate guideline-recommended cancer screening. Consider adding Galleri to annual wellness visits in order to improve the chances of finding cancer early, when it may be more treatable.2
Sample Test Reports:
1-2% of patients with an elevated risk for cancer taking the Galleri test receive a "Cancer Signal Detected" result.1 The Galleri test detected DNA methylation patterns that are often associated with cancer. In the PATHFINDER clinical study, on average, 4 out of 10 people with a "Cancer Signal Detected" result received a cancer diagnosis (Positive Predictive Value or PPV was 43%).1 Every “Cancer Signal Detected” result includes up to two Cancer Signal Origin predictions to guide diagnostic evaluation. With 88% accuracy* in predicting the Cancer Signal Origin, Galleri can help determine appropriate next steps to aid in rapid cancer diagnosis.1
*In the PATHFINDER study for participants with a cancer diagnosis after a "Cancer Signal Detected" result.
Navigating the Galleri test result report
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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.
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.
Schrag D, McDonnall CH, Naduld L, et al. PATHFINDER: A Prospective Study of a Multi-Cancer Early Detection Blood Test. Presentation at European Society of Medical Oncology (ESMO) Congress September 9-13, 2022; Paris, France.
Sasieni P, Clarke CA, Hubbell E. Impact of MCED screening interval on reduction in late-stage cancer diagnosis and mortality. Presentation at European Society for Medical Oncology (ESMO) Virtual Congress; September 16-21, 2021.