To request the test you will need the Galleri Key provided to you by AFFI
Introducing the Galleri multi-cancer early detection test
Galleri is a blood test that can detect 50+ cancer types and can be taken annually.1,2
The Galleri test is available by prescription only. The Galleri test does not detect a signal for all cancers, and false positive or false negative results can occur. The Galleri test should be used in addition to healthcare provider recommended screening tests.
Patient Story: Roger, Cancer Signal Detected with the Galleri test
Patient Story: Roger, Cancer Signal Detected with the Galleri test
The Galleri test is available by prescription only. The Galleri test does not detect a signal for all cancers, and false positive or false negative results can occur. The Galleri test should be used in addition to healthcare provider recommended screening tests.
Why is early detection important?
The Galleri test allows you to screen for more cancers when used in addition to single cancer screening tests.1,4 The Galleri test identifies DNA in the bloodstream shed by cancer cells and does not predict your future genetic risk for cancer.
Only 5 cancers have have recommended screening tests:
breast, cervical, colorectal, lung (for those at risk), cervical and prostate.1
The Galleri test does not detect a signal for all cancers, and false positive or false negative results can occur. The Galleri test should be used in addition to healthcare provider recommended screening tests.
Who is eligible?
AFFI active members and spouses of active members may request the Galleri test at a reduced cost of $649 using the Galleri Key provided to you.
The Galleri test is available by prescription only. 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.
Use of Galleri is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment.
What does the Galleri test result mean?
The Galleri test detected DNA fragments associated with cancer in your blood sample. About 1 out of every 100 test has a Cancer Signal Detected result.4
This result will also include a prediction of the issue type or organ associated with the cancer signal, called a Cancer Signal Origin (CSO). This provides direction to your doctor on the cancer’s origin and can help guide the next steps for diagnosis.2,5
In a clinical study, around 6 out of 10 people with a Cancer Signal Detected result were diagnosed with cancer after diagnostic testing.6*
*Based on the first ~25,000 participants with 1 year of follow-up.
The Galleri test does not detect a signal for all cancers, and false positive or false negative results can occur. The Galleri test should be used in addition to healthcare provider recommended screening tests.
NEXT STEPS
A Cancer Signal Detected test result is not a cancer diagnosis and requires follow-up diagnostic testing. Such testing may include lab work or imagining ordered by your healthcare provider to confirm cancer.
The Galleri test did not detect DNA fragments associated with cancer in your blood sample.
Nearly 99% of people who use the Galleri test will screen negative.4
This result does not completely rule out the possibility of cancer. While the Galleri test is a powerful tool, it cannot detect a signal for all cancers and not all cancers can be detected in the blood. Some cancers shed little or no DNA into the bloodstream, making them unlikely to be detected through a blood test (e.g., brain, skin, and early-stage breast and prostate cancers).7 False positive and false negative results do occur. This result does not predict whether you will develop cancer in the future.
NEXT STEPS
Continue with any routine cancer screenings your healthcare provider recommends. Do not ignore cancer signs or symptoms if they occur, as this could lead to delayed diagnosis.
Cancer can be unpredictable. The Galleri test can be taken as a simple blood test. Adding the Galleri test to an annual routine can improve your chance of finding cancer early.8
Get support
By email: customerservice@grail.com
By telephone: (833) 694‑2553
The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those age 50 or older. The test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. The Galleri test is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of the test 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
- US Preventive Services Task Force. A,B,C grade recommendations, cancer, screening [cited 2025 Mar 18]. https://www.uspreventiveservicestaskforce.org/uspstf/topic_search_results
- 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
- Matrana M, Shukla V, Kingsbury D, et al. Real‑world data and clinical experience from over 100,000 multi‑cancer early detection tests [poster]. American Association for Cancer Research (AACR) Annual Meeting; 2025 Apr 25-30; Chicago. https://assets.grail.com/wp-content/uploads/2025/04/7202.Matrana.AACR-2025-RWE-100K_Poster_Final.pdf
- Schrag D, Beer TM, McDonnell CH, et al. Blood-based tests for multicancer early detection (PATHFINDER): a prospective cohort study. Lancet. 2023;402(10409):1251-60. doi: 10.1016/S0140-6736(23)01700-2
- GRAIL, Inc. Enhanced Cancer Signal Origin prediction. [Data on file: VV-TMF-59592]
- Nabavizadeh N, et al. Safety and performance of a multi-cancer early detection (MCED) test in an intended-use population: initial results from the registrational PATHFINDER2 study [proffered presentation]. European Society for Medical Oncology (ESMO) Annual meeting: 2025 Oct 17-21; Berlin.
- Bredno J, Venn O, Chen X, et al. Circulating tumor DNA allele fraction: a candidate biological signal for multi-cancer early detection tests to assess the clinical significance of cancers. Am J Pathol. 2022; 192(10):1368-78. doi:10.1016/j.ajpath.2022.07.007
- Sasieni P, Clarke CA, Hubbell E. Impact of MCED screening interval on reduction in late-stage cancer diagnosis and mortality. European Society for Medical Oncology (ESMO) Virtual Congress [poster]; 2021 Sep 16-21.
- Thierry AR, El Messaoudi S, Gahan PB, et al. Origins, structures, and functions of circulating DNA in oncology. Cancer Metastasis Rev. 2016;35(3):347-76. doi: 10.1007/s10555-016-9629-x