FAQs
Galleri is a multi-cancer early detection test that can be taken as a simple annual blood test and screens for many of the deadliest cancers before they become symptomatic. The Galleri test gives you more control when it comes to cancer.
In a clinical study, the Galleri test was able to detect a signal shared by more than 50 types of cancer.1 See the list of cancer types study participants had when a cancer signal was detected
Watch a short video to learn more
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. The Galleri test should be used in addition to healthcare provider recommended screening tests.
The test is available by prescription only. You can request a test through your healthcare provider or on our website through an independent telemedicine provider. Download our Patient + Provider Discussion Guide to help start the conversation with your provider.
Cancers growing in the body shed DNA into the bloodstream.1,2,3 Although there are many types of cancer, the DNA fragments can act like a unique “fingerprint” of cancer. This Galleri test screens for many of the deadliest cancers before they become symptomatic, including those without recommended screening tests.1,4 When there is a Cancer Signal Detected, the results also provide predicted Cancer Signal Origin to help your healthcare provider determine the next steps for diagnosis.
*In the PATHFINDER study, Cancer Signal Origin (CSO) prediction accuracy was 88% for participants with a cancer diagnosis among study participants with Cancer Signal Detected test result.
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 is intended to be used in addition to, and not replace, other cancer screening tests your healthcare provider recommends.
Use of Galleri is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment.
More than 1 in 3 people will develop cancer in their lifetime.6 People over the age of 50 have a 13 times higher risk for cancer than those under 50. Cancer risk increases for everyone as they age, regardless of family history7 — only 5% to 10% of cancers are inherited.7,8
The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older.
Talk to your provider about your risk for cancer, and whether the Galleri test is right for you.
In a clinical study, Galleri detected a signal shared by over 50 types of cancer —including some fast-spreading and aggressive cancers responsible for approximately two-thirds of cancer deaths.1 Galleri is a cancer screening test, meaning it looks for cancer before symptoms appear. The Galleri test does not detect a signal for all cancers and not all cancers can be detected in the blood.
See the list of cancer types study participants had when a cancer signal was detected.1
False positive and false negative results do occur.
Nearly 99% of people who take the Galleri test will receive a No Cancer Signal Detected result. A Cancer Signal Detected result is expected in approximately 1% of Galleri tests in people over 50 years of age. After diagnostic evaluation, around 40% of these people are expected to have a confirmed cancer diagnosis.5
Some of the ways we measure test accuracy is with positive predictive value (PPV) and a false positive rate. A PPV is the probability that a person with a Cancer Signal Detected test result has cancer. In a recent study the PPV was 43.1% for study participants with a Cancer Signal Detected result who were diagnosed with cancer. The false positive rate was 0.5% for participants without cancer.5
No, a genetic or hereditary risk assessment is a one time only measurement and assesses your future risk of developing cancer. The Galleri test is a point-in-time test that identifies DNA in the bloodstream shed by cancer cells and screens for cancer at the time of testing.
The test is only available in the US at this time. You can request a test through your healthcare provider or on our website through an independent telemedicine provider.
No, the Galleri test is commercially available in the US only.
Galleri is available by prescription only from your healthcare provider or on our website through an independent telemedicine provider.
We would be happy to share information about the Galleri test with your healthcare provider. Please contact GRAIL Customer Service by completing the online form on the Contact Us web page or calling 833−694−2553. You can also download our Patient + Provider Discussion Guide to share with your provider directly.
You can also request the Galleri test on our website through an independent telemedicine provider.
The cost of the Galleri test may vary depending on the healthcare practice or provider who orders the test. The list price for the Galleri test is $949.
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.
The blood draw is included in the price of the test if scheduled with one of our lab partners. Find a time and location convenient for you to schedule your blood draw at home, at your doctor’s office, or at a partner lab by a trained technician.
A flexible payment plan may assist you with 0% interest for up to 12 months. Learn how to enroll by calling GRAIL Customer Service at 833-694-2553.
If you have received a bill for the Galleri test and need to make a payment, you can do so through one of the convenient methods listed below. A flexible payment plan may also be available. Contact our Billing Support Team for more information at 833-694-2553.
Pay online: Visit our billing portal to pay your bill online by credit card or eCheck.
Pay by phone: Please contact our Billing Support Team at 858-333-5986.
Pay by mail: A check made payable to GRAIL, Inc. can be mailed to: GRAIL, Inc. | Dept LA 25195 | Pasadena, CA 91185-5195
When mailing a check, please:
Write your billing statement number on the memo line.
Include the detachable bottom of your billing statement in the envelope
A limited number of health insurance plans currently cover the Galleri test. The test represents a significant innovation in cancer screening and is gaining coverage with payers. Check with your insurer for coverage, or you may elect to pay for the test yourself.
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.
As each insurance company creates their own criteria for coverage of tests, you may need to work with your healthcare provider and your insurance company to obtain authorization prior to diagnostic testing. If you are unable to obtain coverage, contact a GRAIL patient advocate for additional help with care navigation and coordination with your healthcare provider.
When you’re ready to take the Galleri test, you can schedule your blood draw at a time and place convenient for you:
- One of our partner labs
- Your home, office, or any preferred location by a trained technician
Learn more about how your sample is processed at the GRAIL lab by watching the Life of a Galleri Test Sample video.
First, do not break the quality seal on your sample collection kit. The kit should be opened by the trained technician who draws your blood sample. Make sure you store it at room temperature until your blood draw appointment. The contents are sensitive to extreme temperatures. For example, avoid storing your collection kit in the trunk of your car for long periods of time.
The trained technician who draws your blood will pack and ship your sample back to the GRAIL laboratory for processing.
No fasting is required for the Galleri test.
Approximately 1.5 tablespoons (or about 20 mL) of blood in two tubes is typically drawn from a vein in your arm.
If you no longer wish to receive your Galleri test result, please contact your healthcare provider to request a cancellation. If you are not able to reach your healthcare provider or require further assistance, contact GRAIL Customer Service by completing the online form on the Contact Us web page or by calling 833−694−2553.
If your test has already been processed by the GRAIL laboratory you will be responsible for the cost of the test.
Your sample will arrive at the lab 1 to 2 business days after your blood draw. Test results will be available about two weeks after your sample is received at the GRAIL lab.
Your test results can be requested by contacting GRAIL Customer Service by filling out a support request or calling 833−694−2553.
The Galleri test detected DNA methylation patterns that are often associated with cancer in your blood sample. About 1 out of every 100 tests has a Cancer Signal Detected result.5
This result will also include a prediction of the tissue type or organ associated with the cancer signal, called a Cancer Signal Origin. This helps your doctor determine the next steps for diagnosis.
Results should be interpreted by a healthcare provider. This test 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. GRAIL also offers patients and providers additional support and resources if needed to help guide next steps.
False positive results do occur.
The Galleri test did not detect DNA methylation patterns that are associated with cancer in your blood sample. Nearly 99% of people who use the Galleri test, will receive a No Cancer Signal Detected result.5
This result does not completely rule out the possibility of cancer. The Galleri test does not detect a signal for all cancers and not all cancers can be detected in the blood. This result does not predict whether you will develop cancer in the future.
The Galleri test can be taken as an annual blood test. Adding the Galleri test to annual wellness visits allows you to go further with cancer screenings. Ask your healthcare provider when is best to test again.
False negative results do occur.
The Galleri test is intended to be used in addition to — and not replace — other cancer screening tests your healthcare provider recommends. Single-cancer screening tests are recommended because they have been proven to save lives by detecting cancer early. Adding the Galleri test to annual wellness visits allows you to go further with cancer screenings.
The Galleri test does not detect a signal for all cancers and not all cancers can be detected in the blood.
A Cancer Signal Detected test 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. GRAIL also offers patients and providers additional support and resources if needed to help guide next steps.
Cancer can be unpredictable. The Galleri test can be taken as an annual blood test. Ask your healthcare provider when is best to test again.
All results are automatically shared with the provider who ordered the test. If you would like us to fax your result to an additional healthcare provider, contact GRAIL Customer Service and complete the online form on the Contact Us web page or call 833−694−2553 to receive instructions on how to complete a results release form.
Have more questions?
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 Sep;32(9):1167-77. doi: 10.1016/j.annonc.2021.05.806
Liu MC, Oxnard GR, Klein EA, et al. Sensitive and specific multi-cancer detection and localization using methylation signatures in cell-free DNA. Ann Oncol. 2020 Mar 30;31(6):745-59. doi: 10.1016/j.annonc.2020.02.011
Thierry AR, El Messaoudi S, Gahan PB, et al. Origins, structures, and functions of circulating DNA in oncology. Cancer Metastasis Rev. 2016 Jul 8;35:347–76. doi: 10.1007/s10555-016-9629-x
US Preventive Services Task Force. A,B,C grade recommendations, cancer, screenings. [cited 2023 Oct 23]. https://www.uspreventiveservicestaskforce.org/uspstf/topic_search_results
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
American Cancer Society. Lifetime risk of developing or dying from cancer. [cited 2023 Oct 11]. https://www.cancer.org/cancer/cancer-basics/lifetime-probability-of-developing-or-dying-from-cancer.html
Surveillance, Epidemiology, and End Results (SEER) Program SEER*Stat Database: Incidence - SEER Research Limited-Field Data, 21 Regs, 2020 Nov Sub (2000-2018) - Linked To County Attributes - Time Dependent (1990-2018) Income/Rurality, 1969-2019 Counties, National Cancer Institute, DCCPS, Surveillance Research Program, released 2021 Apr, based on the 2020 Nov submission. [Risk Factor Data on file: American Cancer Society Cancer Prevention Studies II/III.]
NIH, National Cancer Institute. Genetic testing for inherited cancer susceptibility syndromes. [cited 2023 Mar 3]. https://www.cancer.gov/about-cancer/causes-prevention/genetics/genetic-testing-fact-sheet
American Association for Cancer Research. Cancer progress report 2023. https://cancerprogressreport.aacr.org/progress/