Understanding your results

Your guide to Galleri® test results

The Galleri multi-cancer early detection test screens for multiple cancers with a single blood test. In a clinical study, the Galleri test was able to detect a signal shared by more than 50 types of cancer.1

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Things to remember:

  • Galleri is a screening test and does not diagnose cancer. Diagnostic testing is needed to confirm cancer.
  • The Galleri test looks for active cancer and does not predict your future genetic risk for cancer.
  • The Galleri test does not detect a signal for all cancers and not all cancers can be detected in the blood.
  • False positives and false negative results do occur.

Have you already taken the Galleri test?

We would love to hear from you!

How to interpret your results

There are two possible test results:

  • No Cancer Signal Detected
  • Cancer Signal Detected

If Galleri detects a cancer signal, your result will include one or two Cancer Signal Origins which predict the tissue type or organ associated with the cancer signal.

You will not receive a list of the 50+ types of cancer and a result for each one.

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What do Galleri test results mean?


What does a “Cancer Signal Detected” result mean?


The Galleri test looked for a cancer signal in your blood sample and found one. About 1 out of every 100 tests has a Cancer Signal Detected result.2*

This result will also include one or two predictions of the tissue type or organ associated with the cancer signal, called ​"Cancer Signal Origin."

In a clinical study, around 4 out of 10 people with this result were diagnosed with cancer after diagnostic testing.2

*In the PATHFINDER study2, out of 6,578 participants tested with Galleri, 58 had a Cancer Signal Detected result.

cancer signal origin image

Other: Anus, Bone and Soft Tissue, Head and Neck, Lymphoid Lineage, Melanocytic Lineage, Myeloid Lineage, Neuroendocrine Cells of Lung or other Organs, Plasma Cell Lineage, Thyroid Gland, Uterus.

Cancer signal detected thumb

NEXT STEPS

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.

The cost of the Galleri test does not include additional diagnostic testing to confirm cancer. If you need help obtaining insurance coverage for diagnostic tests, please contact the GRAIL patient advocate, patient-advocate@grailbio.com for assistance.

What does a “No Cancer Signal Detected” result mean?


The Galleri test looked for a cancer signal in your blood sample and did not find one.

In a clinical study, less than 2% of individuals with a No Cancer Signal Detected result had cancer.1,2

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.

Cancer signal not detected thumb

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 a delayed diagnosis.

Adding Galleri to annual wellness visits can improve the chances of finding cancer early when there are more treatment options.1 Ask your healthcare provider when is best to test again.

How does the test work?

All cells in your body, including cancer cells, contain DNA. DNA from cancer cells is different from healthy cell DNA. When cells complete their life cycle and die, fragments of their DNA enter the bloodstream.3 These fragments are called cell-free DNA. The Galleri test screens your blood sample for cell-free DNA and identifies whether it comes from healthy or cancer cells.2

DNA from cancer cells has specific methylation patterns that identify it as cancer. Methylation is a natural process that can change the activity of DNA. Methylation patterns also contain information about the tissue type or organ associated with the cancer signal.4

illustrated graphic video explaining how the Galleri test works

How can Galleri tell cancer DNA from healthy DNA?

The Galleri test learns from a database that has thousands of samples from healthy DNA and cancer DNA.1,3,4 

This database is the largest of its kind in the world, created using advanced technology that allows Galleri to detect a Cancer Signal and predict the Cancer Signal Origin.1,3,5

illustrated graphic with a blood vial icon next to DNA icons indicating cell-free DNA from healthy cell and cell-free DNA from a cancer cell

Frequently asked questions for patients about the Galleri 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 a signal often associated with cancer. This result will also include one or two predictions of the tissue type or organ associated with the cancer signal, called ​“Cancer Signal Origin.”

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 looked for a cancer signal in your blood sample and did not find one. 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. Continue with routine cancer screenings your healthcare provider recommends. This result does not predict whether you will develop cancer in the future.

False negative results do occur.

Adding Galleri to annual wellness visits can improve the chance of finding cancer early when it may be more treatable. Ask your healthcare provider when it’s time for your next test.

Single-cancer screening tests are recommended because they have been proven to save lives by detecting cancer early. Using Galleri in addition to recommended single-cancer screenings can increase your chances of finding cancer early, when there may be more treatment options. Galleri 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.

Adding Galleri to annual wellness visits can improve the chances of finding cancer early when there may be more treatment options. 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 results to an additional healthcare provider, please contact Customer Service by filling out a support request or calling 833−694−2553 to receive instructions on how to complete a results release form.

The Galleri test is a multi-cancer early detection test that screens for a signal shared by more than 50 types of cancer, many that lack recommended screening through a single blood draw. Galleri is a screening test and does not diagnose cancer. Diagnostic testing is needed to confirm cancer. Galleri should be used in addition to healthcare provider recommended screening tests.

Watch a short video to learn more

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.

Every time you take the test, Galleri checks more than 100,000 DNA regions and over a million specific DNA sites to screen for a signal shared by multiple cancers. If a cancer signal is detected, results from the test predict the tissue type or organ associated with the cancer signal to help your healthcare provider determine next steps.

Watch a short video to learn more

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.

Cancer risk increases for everyone as they age regardless of family history—only 5% to 10% of cancers are inherited.

Age is the biggest risk factor for cancer. In fact, adults over age 50 are 13 times more likely to have cancer compared to people under the age of 50. 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. 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.

Based on clinical study data, the test's sensitivity varies across different cancers (and stages). You can find sensitivity information for 24 cancer classes at: https://www.galleri.com/hcp/galleri-test-performance

A “Cancer Signal Detected” result is expected in approximately 1% or 1 out of 100 Galleri tests of Galleri tests in people over 50 years of age.

In a recent clinical study, on average, 4 out of 10 people with a "Cancer Signal Detected" result received a cancer diagnosis with diagnostic testing, and 1 out of 200 people without cancer received a "Cancer Signal Detected" result.

(Positive Predictive Value was 43% and False Positive rate was 0.5%).

No, the Galleri test is not a genetic risk assessment. A genetic risk assessment is a one time only measurement and assesses your future risk of developing cancer. The Galleri test looks for a signal associated with active cancer at the time of your blood draw. Genetic tests may look at DNA and assess lifelong risk for cancer but cannot detect if a person currently has cancer.

Our goal is for Galleri to be a annual cancer screening test. By regularly using the Galleri test alongside recommended cancer screenings, you can increase your chance of finding cancer early.

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 only commercially available in the US.

Galleri is available by prescription only from your healthcare provider or on our website through an independent telemedicine provider. Visit our website to learn more about requesting the test.

We would be happy to share information about the Galleri test with your healthcare provider. Please contact GRAIL Customer Service by filling out a support request 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 partners. An at-home or in-lab blood draw with a GRAIL partner is included in the price of your Galleri test. Find a time and location convenient for you at galleri.com/schedule.

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.

  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, LLC. can be mailed to: GRAIL, LLC. | 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. You should 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 diagnostic tests, you may need to work with your healthcare provider and your insurance company to obtain coverage prior to diagnostic testing. If you are unable to obtain coverage, please contact the GRAIL patient advocate, patient-advocate@grailbio.com for additional help with care navigation and coordination with your healthcare provider.

When you’re ready to take the Galleri test, your blood can be drawn at:

  • Your healthcare provider’s office or lab

  • Scheduled at a time and place convenient for you, visit: galleri.com/schedule
    • One of our partners’ 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 this video.

Once you receive your sample collection kit, please do not break the quality seal on it. The collection 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 or preparation is required for the Galleri test.

Approximately 1.5 tablespoons (or about 20 mL) of blood is drawn in two tubes typically from a vein in your arm.

If you no longer wish to receive your Galleri results, please contact your healthcare provider to request a cancellation. If you are not able to reach your healthcare provider or require further assistance, please contact GRAIL Customer Service by filling out a support request or calling 833−694−2553.

If your test has already been processed by GRAIL’s laboratory you will be responsible for the cost of the test.

For test orders requested through Galleri.com, refunds can only be issued if requested within 30 days of ordering and your sample has not been received at the GRAIL laboratory.

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.

  1. 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: https://doi.org/10.1016/j.annonc.2021.05.806

  2. Schrag D, Beer TM, McDonnell CH, et al. Evaluation of Anxiety, Distress and Satisfaction With a Multi-Cancer Early Detection Test. Ann Oncol. 2022;33(suppl 7):S963. DOI: https://doi.org/10.1016/j.annonc.2022.07.1034.

  3. Thierry A, El Messaoudi S, Gahan P, et al. Origins, structures, and functions of circulating DNA in oncology. Cancer Metastasis Rev. 2016;35:347–76. DOI: https://doi.org/10.1007/s10555-016-9629-x.

  4. 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):745-759. DOI: https://doi.org/10.1016/j.annonc.2020.02.011.

  5. Ofman J, Hall M, Aravani A. GRAIL and the quest for earlier multi-cancer detection. Nature Portfolio. March 25 2020.