Galleri: A Multi-Cancer Early Detection Test Columbus Ohio
Early Detection Is EVERYTHING
A test that only requires 2 tubes of blood. Results back in 10-14 days.
Explore enhanced cancer screening capabilities with Galleri®, a groundbreaking approach to detecting a wider range of cancers. By incorporating Galleri, a cutting-edge multi-cancer early detection test, into your screening regimen, you can transcend the limitations of current methods. With Galleri, you can now identify a common indicator found in over 50 different cancer types, expanding your screening horizons.
The Galleri test does not identify signals for every type of cancer, and it’s important to note that not all cancers manifest detectable markers in the bloodstream. Therefore, it is advisable to utilize Galleri as a supplementary measure alongside the cancer screening tests recommended by your healthcare provider.
Galleri conducts screenings to detect a distinct signal linked to the presence of active cancer.
This comprehensive test meticulously examines over 100,000 DNA regions and scrutinizes more than a million specific DNA sites to identify a common marker indicative of potentially concealed cancers. Within the Galleri test, the analysis focuses on cell-free DNA and distinguishes between DNA originating from healthy cells and that originating from cancerous cells. The presence of specific methylation patterns in the DNA from cancer cells serves as a distinctive identifier of the cancer signal. Additionally, these methylation patterns provide insights into the tissue type or organ associated with the detected cancer signal, thereby guiding subsequent actions and decisions.
What’s the science? A lot.
Supported by thorough clinical substantiation.
Galleri underwent assessment in clinical investigations involving more than 20,000 participants. The test was created by GRAIL and its clinical laboratory holds certification in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accreditation from the College of American Pathologists (CAP).
Take your cancer screening to the next level.
- Galleri sets new benchmarks for possibilities. Currently, only five types of cancers have established screening recommendations. Incorporating Galleri into these screenings can significantly enhance the likelihood of detecting cancer at an earlier stage, facilitating prompt treatment. Galleri is designed to identify a common marker shared by numerous cancer types that might otherwise remain undetected. In the event of identifying a cancer signal, Galleri also provides insights into the specific tissue type or organ associated with that signal, offering valuable guidance for subsequent actions.
Galleri Patient Experiences
Important Information Regarding Galleri Testing
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.
Laboratory Test Information
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.
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.
Liu MC, Oxnard GR, Klein EA; et al. for CCGA Consortium. 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.
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.
Schrag D, McDonnall CH, Naduld L, et al. PATHFINDER: A Prospective Study of a Multi-Cancer Early Detection Blood Test. Presentation at European Society of Medical Oncology (ESMO) Congress September 9-13, 2022; Paris, France.
US Preventive Services Task Force. Recommendations Cancer. Accessed 7Mar2023. https://www.uspreventiveservicestaskforce.org/uspstf/topic_search_results.
The list price for the Galleri test is $949. This is payable directly to Galleri/Grail.
Most health insurance plans do not cover the cost of the Galleri test.
Our clinic consult fee for this test is $200, payable to our clinic. If found to be an appropriate candidate, this will include our lab draw costs at the clinic, specimen handling, shipping, and follow up lab review.
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.
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
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, email@example.com for assistance.
If I have a positive cancer signal, what next?
Great question. We are trying to create improved access to tests that may help clients.
If a positive cancer signal is detected, clients will need to follow up with their primary care physicians or specialists to determine if, what, and how further screening and investigation needs to be done.
As a clinic that does not accept insurance, we feel it's important that clients know this, and that we require clients to have access and follow up with an established PCP prior to testing for their safety.
As we are no longer full scale primary care, we do not perform the further investigation.
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