Screening for multiple cancers is now possible with Galleri®
With over 50 types of cancer detected to date through a shared cancer signal, Galleri is redefining early cancer detection.1
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 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.
Start testing with Galleri
Galleri is a screening test that looks for cancer before symptoms appear, when cancer may be easier to treat. It is important to get cancer screenings even if you feel fine.1
Only Galleri gives you the power to screen early for a signal shared by multiple cancers.2
Multi-cancer early detection
Galleri goes further, improving your chance of finding cancer early when used in addition to recommended screening tests. Galleri detects a signal shared by multiple cancers.2
Testing with ease
A simple blood draw that can be easily incorporated into your routine wellness visit.
No fasting or preparation required.
Proactive health information
Results that give you the confidence to know you’ve done more. If a cancer signal is found, results can predict the tissue type or organ associated with the cancer signal to help your healthcare provider guide next steps.2
How Galleri works
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
There are two ways to request Galleri®
Galleri is available by prescription only and must be ordered by a healthcare provider. You can request the test through your healthcare provider or online through an independent telemedicine provider.
Talk to your healthcare provider
At your next wellness visit, ask your healthcare provider about Galleri. Our discussion guide can help start the conversation.
Request online
You can also request Galleri online through an independent telemedicine provider from PWNHealth.
Our testing process
1. Request the test
The Galleri test is available by prescription only. Your healthcare provider can order the test, or you can request it through our website from an independent telemedicine provider.
2. Blood Draw
Complete your blood draw at your provider's clinic
OR
Schedule your blood draw with one of our partners. There are two ways: (1) have a trained technician come to you or (2) visit a partner lab location near you.
3. Test results
Test results are available about two weeks after your sample is received at the GRAIL lab.
Understanding your results
There are two possible test results:
- No Cancer Signal Detected
- Cancer Signal Detected
You will not receive a list of the 50+ types of cancer and a result for each one.
A Galleri result of No Cancer Signal Detected does not rule out cancer.
Galleri is a screening test and does not diagnose cancer. Diagnostic testing is needed to confirm cancer.
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.
Have more questions?
To connect with GRAIL Customer Service, please fill out this form.
American Cancer Society. All About Cancer. Find Cancer. Early Get Screened.
https://www.cancer.org/cancer/screening/get-screened.html.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.
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.
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.