Galleri Multi-Cancer Early Detection Test
Galleri Multi-Cancer Early Detection Test
A new way to screen for more cancers
Georgia Cancer Center is pleased to be the first in the region to offer the Galleri® Multi-Cancer Early Detection (MCED) blood test - a new way to screen for cancers. Many cancers can start to grow but show no symptoms until later stages; with this new test, we are able to look for a signal shared by more than 50 types of cancer. If a cancer signal is found, the results predict where in the body the cancer may be located to help your provider guide your next steps.
The MCED test should be done in addition to, not in place of, any annual cancer screenings recommended by your healthcare provider. This test does not detect all cancers and is not meant to replace genetic testing for those at increased risk of hereditary cancers.
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Who should get tested?
The MCED test is recommended for those 50 or older who are at elevated risk for cancer. Seek your doctor’s advice if you are pregnant, 21 or younger, or are currently being treated for cancer.
You're eligible if:
- You're 50 years of age or older
- You are not pregnant
- You've not been diagnosed with or treated for cancer within the last 3 years (excluding basal or squamous skin cancers or hormonal therapy for breast cancer)
- Have one or more of the following lifestyle risk factors:
- Have a first degree relative who has had cancer (parent, child and/or full sibling)
- Heavy alcohol use (regularly over 8 servings per week)
- Tobacco use (over 20 pack year history)
- Survivor of childhood or young adult cancer
- Do you have one or more of the following health risk factors?
- Barrett's esophagus
- Any known or deleterious germline mutations (such as BRCA1/2, CDH1, etc.)
- Crohn's Disease/Inflammatory bowel disease
- Elevated PSA with negative biopsy
- Epstein-Barr Virus (EBV)
- H. Pylori
- Hepatitis B or C
- Lymphocytosis (over 4000 lymphocytes/microL)
- Taking biologics such as Humira
- Transplant recipient
Cost and Insurance
The MCED test through Wellstar MCG Health costs $799 and is not covered by insurance.
Who confirms my eligibility and orders the Galleri test for me?
Your provider will review your test request and clinical eligibility. The provider will approve your request and order the test if appropriate.
What is the Galleri test?
Through a simple blood draw, the Galleri multi-cancer early detection test detects a cancer signal shared by more than 50 types of cancer, many of which are not commonly screened for today.
The Galleri test does not detect all cancers and not all cancers may be detected in the blood.
The Galleri test is intended to be used in addition to, and not to replace, other cancer screening tests your healthcare provider recommends.
How can the Galleri test detect cancer in the blood?
The Galleri test looks for a signal present in the blood that may be associated with cancer at the time of your blood draw. If a cancer signal is detected, the results can point to where in the body the cancer signal is coming from to help your healthcare provider guide next steps. The Galleri test is recommended to be used along with other cancer screening tests such as colonoscopy or mammogram.
I am not at risk for cancer, nor do I have family history. Is the Galleri test really for me?
Family history is one of many risk factors associated with cancer development. Other risk factors include age, eating habits, lifestyle, living or working environments, genetics, and many others**.
What cancers does the Galleri test detect?
In a clinical validation study (CCGA3*), the Galleri test detected a cancer signal shared by more than 50 types of cancer across all stages.
Why is the Galleri test recommended to be used along with other cancer screening tests?
The Galleri test detects a cancer signal shared by more than 50 types of cancers, however not all cancers can be detected in the blood. Recommended routine cancer screening tests such as colonoscopy or mammogram have been shown to reduce cancer deaths.
The Galleri test is intended to be used in addition to and not to replace these tests and can help maximize the benefits of early cancer detection. Missing recommended screening or ignoring symptoms could lead to a delayed diagnosis of cancer.
What is the false positive rate of the Galleri test?
Based on data from our studies, the Galleri test has shown a low false-positive rate of 0.5% (detects a cancer signal when no cancer is present). This means that in approximately 200 people tested, only one person would be expected to receive a false positive result.
What data support the Galleri test?
The Galleri test development was supported by what is believed to be one of the largest clinical study programs in genomic medicine, with more than 20,000 participants at more than 140 clinical study sites, including the Mayo Clinic, Dana-Farber Cancer Institute, Cleveland Clinic, Sutter Health, Oregon Health & Science University, Intermountain Healthcare and U.S. Oncology Network.
Is the Galleri test FDA approved?
The Galleri test has not been cleared or approved by the FDA. Galleri is a Laboratory Developed Test. GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists (CAP). GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing.
Test Process and Blood Draw FAQs
Do I need to fast prior to the blood draw?
No preparation or fasting is required.
How much blood is needed for the Galleri test?
The test uses approximately 1.5 tablespoons (or about 20 mL) of blood in two tubes, typically from a vein in your arm.
Test Results and Privacy FAQs
How long does it take to return my Galleri test results?
Your sample will arrive at the lab one to two business days after your blood draw. Your results should be available to the ordering provider who ordered your test within 10 business days (Monday — Friday, excluding holidays) from the time your sample is received at GRAIL.
You will receive your results about two weeks after your blood draw from the ordering provider.
How do I cancel my test order if I no longer want to receive my results?
What does it mean if I receive a “No Cancer Signal Detected” result?
This means that no cancer signal was found in your blood test. However, not all cancers can be detected by the Galleri test. Continue with all routine screening tests that your healthcare provider recommends. Missing routine screenings or ignoring symptoms can lead to a delayed diagnosis of cancer.
What does it mean if I receive a “Cancer Signal Detected” result?
This means that there is a suspicion of cancer and additional tests are needed to see if you have cancer. The provider who ordered your test will share next steps as appropriate.
The Galleri test can point to where in the body the cancer is coming from to help your primary healthcare provider guide next steps. Your provider will coordinate to order appropriate follow-up testing to confirm if cancer is present.
Why are additional tests needed when the Galleri test detects a cancer signal?
Galleri is a screening test that detects a cancer signal in blood. When a signal is detected, the Galleri test also predicts where in the body the signal is coming from.
The Galleri test is not a diagnostic test. Additional tests, which may include blood work or imaging, ordered by your primary healthcare provider are needed to confirm if cancer is present.
What happens if I get a false positive?
If a diagnostic evaluation after a “Cancer Signal Detected” result with Galleri does not confirm cancer, you may be eligible for a complementary re-test with Galleri.
The request for a re-test must be placed by the healthcare provider who will order the re-test. The re-test must be administered within 3 – 6 months after the initial Galleri test. To initiate a
Why should I take the Galleri test in the future if a cancer signal is not detected?
The Galleri test is looking for the presence of cancer at the time your blood is drawn, but you may develop cancer in the future. The test does not measure your risk of developing cancer in the future, and it does not detect all cancers.
Who can see my test result?
The healthcare provider who orders the test will receive your test result and share it with you. Your test result and medical information are confidential, and access is limited to individuals who need the information for a specific purpose, such as the ordering provider and a GRAIL Patient Advocate. The ordering provider will help you understand your test results and determine your next steps. A GRAIL Patient Advocate can also provide post-positive test result support for diagnostic workup, benefits connectivity, assistance, and support with continuity of care / payer coverage assistance.
For example, if a cancer signal is detected, your test result may be shared with your primary healthcare provider so they can be aware and involved with your next steps.
Additional details about privacy and data use are included in the Galleri patient portal when you request the test (see: Galleri Patient Information Sheet).
Important Safety Information
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.
GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists (CAP). 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. GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes.
Galleri is a registered trademark of GRAIL, LLC, and is manufactured by GRAIL.
Klein EA, et al. Ann Oncol. 2021;32(9): 1167 – 1177. doi: 10.1016/j.annonc.2021.05.806.
The Galleri test does not detect all cancers nor does it measure your genetic risk of developing cancer in the future. It should be used in addition to routine screening tests your healthcare provider recommends.