Incorporate the Galleri® test seamlessly into your practice
GRAIL offers resources and support to help providers add Galleri into their practices. The Galleri test only requires a simple blood draw, allowing integration into existing patient interactions such as annual health checks or routine blood work.
Recommended use
The Galleri test is recommended for use in adults with an 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
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 result indicates that the Galleri test did not detect a methylation pattern associated with cancer.1 Of patients tested with the Galleri test, approximately 99% will have a No Cancer Signal Detected result. When patients receive a No Cancer Signal Detected result, continue with appropriate guideline-recommended cancer screening.2
While the Galleri test does not detect all cancers and a No Cancer Signal Detected does not rule out cancer, this result can provide reassurance to you and your patients.3 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%).2
Sample Test Reports:
A Cancer Signal Detected result indicates that the Galleri test detected cfDNA with methylation patterns often associated with cancer.1 Approximately 1% of patients will receive a Cancer Signal Detected result.1,2 A Cancer Signal Detected result should be followed with a diagnostic assessment guided by the predicted Cancer Signal Origin.2
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%).2
*In the PATHFINDER study for participants with a cancer diagnosis after a "Cancer Signal Detected" result.
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By submitting this form, you agree to GRAIL’s use of this information to contact you, including for marketing purposes. Please do not include any sensitive or confidential information, including health information. For more information, please refer to our privacy notice.
By submitting this form, you agree to GRAIL’s use of this information to contact you, including for marketing purposes. Please do not include any sensitive or confidential information, including health information. For more information, please refer to our privacy notice.
By submitting this form, you agree to GRAIL’s use of this information to contact you, including for marketing purposes. Please do not include any sensitive or confidential information, including health information. For more information, please refer to our privacy notice.
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.
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.
- Klein EA, Richards D, Cohn A, et al. Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set. Ann Oncol. 2021;32(9):1167-77. doi: 10.1016/j.annonc.2021.05.806
- Schrag D, Beer TM, McDonnell CH, et al. Blood-based tests for multi-cancer early detection (PATHFINDER): a prospective cohort study. Lancet. 2023;402:1251-1260. doi: 10.1016/S0140-6736(23)01700-2
- Schrag D, Beer TM, McDonnell CH, et al. Evaluation of anxiety, distress and satisfaction with a multi-cancer early detection test. European Society of Medical Oncology (ESMO) Congress [poster]; 2022 Sep 9-13; Paris, France. https://grail.com/wp-content/uploads/2022/09/Schrag_908P_ESMO-2022_Pathfinder-PROs_Poster_Final.pdf