FAQs

for Patients about the Galleri® test


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The Galleri test screens for multiple cancers and can be taken annually as a simple blood draw. The test can screen for many aggressive cancers before symptoms appear.2,5,6 

In a clinical study, the Galleri test detected a signal shared by more than 50 types of cancer.2 See the list of cancer types the Galleri test detected.

Watch the short video What is Galleri 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.

The Galleri test is available by prescription only.

A: Cancers growing in the body shed DNA into the bloodstream. Although there are many types of cancer, the DNA fragments act like a unique fingerprint of cancer.2,3,4 The Galleri test can screen for many aggressive cancers before they become symptomatic,1 including those with no recommended screening tests.2,5,6 With this unique fingerprint of cancer, the Galleri test helps to provide direction to your healthcare provider on the cancer’s origin and the next steps in diagnosis.1,7

Watch the short video How Does the Galleri Test Work? 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 identifies DNA in the bloodstream shed by cancer cells and does not predict future genetic risk for cancer.

 The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those age 50 or older.

Use of the Galleri test is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment.

The Galleri test should be used in addition to healthcare provider recommended screening tests.

More than 1 in 3 people will develop cancer in their lifetime.8 People over the age of 50 are 13 times more likely to have cancer than those under 50.9 Cancer risk increases for everyone as they age, regardless of family history — only 5% to 10% of cancers are inherited.9,10

- The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those age 50 or older.

Talk to your provider about your risk for cancer and whether the Galleri test is right for you. The Galleri test is available by prescription only.

Learn more about cancer risk

In a clinical study, the Galleri test detected a signal shared by more than 50 types of cancer — including some fast-spreading and deadly cancers responsible for approximately two-thirds of cancer deaths.2,5 Galleri is a cancer screening test, meaning it looks for cancer before symptoms appear.1,11 

See the list of cancer types study participants had when a cancer signal was detected.3

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.

Nearly 99% of people (ages 50-79) who take the Galleri test will receive a No Cancer Signal Detected result.1 In other words, approximately 1% are expected to receive a Cancer Signal Detected result. After diagnostic evaluation, around 40% of people with a Cancer Signal Detected result are expected to have a confirmed cancer diagnosis.1

Some of the ways we measure test accuracy are 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.1 The false positive rate was 0.5% for participants without cancer.1,2

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.

 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 active cancer cells.2 

The test is broadly available only in the US at this time. You can request a test through your healthcare provider or on our website through an independent telemedicine provider.

We are happy to share information about the Galleri test with your healthcare provider. 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 provider who orders the test. The list price for the Galleri test is $949.

You may be able to use pretax 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 if the test is scheduled with one of our GRAIL lab partners. Find a convenient time and location to schedule your blood draw at home, your doctor’s office, or 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 858-333-5986.

  1. Pay online: Visit our billing portal to pay your bill online by credit card or eCheck.
  2. Pay by phone: Please contact our Billing Support Team at 858-333-5986.
  3. 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 coverage with payers will continue to evolve over time. Patients may elect to pay for the test themselves and/or check with their insurer for coverage before requesting the test. 

The Galleri test is now covered for eligible beneficiaries through TRICARE. Prior authorization is required.

You may be able to use pretax 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

Watch the Clinical Laboratory Virtual Tour video to learn more about how your sample is processed at the GRAIL lab. 

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.

Typically, you can expect to receive your test result about 2 weeks after your sample arrives at the GRAIL lab. In certain cases, results may take up to 4 weeks. 

If you have not received your result within 2 weeks, GRAIL will notify you via email (sent to your email address if one was provided on your Test Requisition Form). 

It is important to understand that the timing of your test result does not indicate or predict the outcome of the test, nor does it impact the accuracy of the final result.

If you provide your email when ordering the test, your result will be emailed to you. You can also request your test result by contacting GRAIL Customer Service via the Contact Us online form or by calling (833) 694‑2553.

The Galleri test detected DNA methylation patterns often associated with cancer in your blood sample. About 1 out of every 100 tests has a "Cancer Signal Detected" result.1

This result will also include a prediction of the tissue type or organ associated with the cancer signal, called a ​Cancer Signal Origin (CSO). The CSO helps your doctor determine the next steps for diagnosis.2

A healthcare provider should interpret the results. The 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 the next steps.

The Galleri test does not detect a signal for all cancers and not all cancers can be detected in the blood. 

The Galleri test did not detect DNA methylation patterns associated with cancer in your blood sample. Nearly 99% of people who use the Galleri test will receive a "No Cancer Signal Detected" result.1

This result does not completely rule out the possibility of cancer and you should continue with other cancer screenings your provider recommends.. 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 identifies DNA in the bloodstream shed by cancer cells and does not predict future genetic risk for cancer.

The Galleri test can be taken as an annual blood test. Adding the Galleri test to annual wellness visits can improve your chance of finding a cancer signal early when more treatment options may be available.1,6,12,13 Ask your healthcare provider when it 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 can improve your chance of finding a cancer signal early when more treatment options may be available.1,6,12,13

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 to confirm cancer. Follow-up diagnostics 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 the next steps.

Cancer can be unpredictable. The Galleri test can be taken annually and added to your yearly wellness visits. Aggressive cancers can develop and progress quickly, sometimes in less than a year.12,13 Ask your healthcare provider when would be the best time to schedule your next test.

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.

An earlier version of the Galleri test included either one (in most cases) or two Cancer Signal Origins with a Cancer Signal Detected result. The current version of the Galleri test includes one Cancer Signal Origin with a Cancer Signal Detected result. This change helps guide diagnostic follow-ups and is based on ongoing improvements in our science and data. The improved accuracy is 93.4%7 of the Cancer Signal Origin that predicts the tissue type or organ associated with the cancer signal.

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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.

  1. Schrag D, Beer TM, McDonnell CH, et al. Blood-based tests for multi-cancer early detection (PATHFINDER): a prospective cohort study. Lancet. 2023;402(10409):1251-60. doi: 10.1016/S0140-6736(23)01700-2
  2. 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
  3. 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;31(6):745-59. doi: 10.1016/j.annonc.2020.02.011 
  4.  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
  5. American Cancer Society. Cancer facts & figures 2022. https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2022.html [GRAIL, Inc. Data on file: GA-2021-0065]
  6. US Preventive Services Task Force. A,B,C grade recommendations, cancer, screening [cited 2025 Mar 18]. https://www.uspreventiveservicestaskforce.org/uspstf/topic_search_results
  7. Enhanced Cancer Signal Origin prediction. [GRAIL, Inc. Data on file: VV-TMF-59592]
  8. American Cancer Society. Lifetime risk of developing or dying from cancer [cited 2025 Mar 11]. https://www.cancer.org/cancer/cancer-basics/lifetime-probability-of-developing-or-dying-from-cancer.html
  9. 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] 
  10. U.S, Center for Disease Control and Prevention. Cancer Screening Tests [cited 2025 Jan 16] https://www.cdc.gov/cancer/prevention/screening.html#:~:text=Screening%20means%20checking%20your%20body,is%20likely%20to%20work%20best.
  11. 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
  12. Patel A. Methylated DNA biomarkers and incident cancer in the American Cancer Society (ACS) Cancer Prevention Study-3 (CPS-3) cohort. American Society of Clinical Oncology (ASCO) Annual Meeting; 2023 Jun 2-6. https://meetings.asco.org/abstracts-presentations/218486
  13. 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.