Cancer needs a quick response time, too
The majority of cancer types have no recommended screening and can go undetected for too long.1,2 Adding the Galleri® multi-cancer early detection test can help fill that gap by screening for some of the deadliest cancers including those we don’t have screening tests for today like pancreatic, lymphoma and head and neck, all through a simple blood draw.
Sensitivity in study participants with - Pancreas cancer: 83.7% overall (61.9% stage I, 60.0% stage II, 85.7% stage III, 95.9% stage IV). Lymphoma: 56.3% overall (27.3% stage I; 58.3% stage II; 71.7% stage III; 60.9% stage IV) . Head and neck cancer: 85.7% overall (63.2% stage I, 82.4% stage II, 84.2% stage III, 96.0% stage IV).
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.
Galleri was studied in a population age of 50 and older and studies specific to firefighters have not been conducted. Based on a clinical study of people ages 50 to 79, around 1% are expected to receive a cancer signal detected result. After diagnostic evaluation, around 40% of these people are expected to have a confirmed cancer diagnosis.
Galleri should be used in addition to provider recommended screenings.
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.
Galleri was studied in a population age of 50 and older and studies specific to firefighters have not been conducted. Based on a clinical study of people ages 50 to 79, around 1% are expected to receive a cancer signal detected result. After diagnostic evaluation, around 40% of these people are expected to have a confirmed cancer diagnosis.
Galleri should be used in addition to provider recommended screenings.
The Galleri story
How Galleri Works
All cells, healthy and cancerous, release DNA into the bloodstream. But DNA from cancer cells is different from DNA from healthy cells. Using next-generation DNA sequencing, machine learning, and AI, the Galleri test can detect a cancer signal in the blood and predict the tissue or organ associated with the cancer signal.
Validated by rigorous clinical studies, the Galleri test detects abnormalities in the methylation patterns of cell-free DNA (cfDNA) that could indicate the presence of cancer. When used alongside guideline recommended screening tests, the Galleri test can improve the chance of finding a cancer signal early.
The studies that support Galleri performance included more than 140 clinical study sites, including
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Frequently Asked Questions
The Galleri test identifies DNA in the bloodstream shed by cancer cells at the time of your blood draw. If a cancer signal is detected, Galleri results include a prediction of the organ or tissue type associated with the cancer signal to help your healthcare provider guide next steps.
The Galleri test should be used in addition to guideline-recommended cancer screening, such as mammography, colonoscopy, prostate specific antigen (PSA) or cervical cancer screening. Galleri is recommended for use in adults with an elevated risk of cancer, such as those aged 50 or older.
Your GRAIL team can work with you to plan an onsite event where an ordering provider orders the test where participants have their blood drawn.
We also have the ability to offer the test through telemedicine, and an independent healthcare provider will review the request and order the test, if appropriate. The test is prescription only.
The Galleri test detects a cancer signal shared by more than 50 cancers. The Galleri test does not detect a signal for all cancers and not all cancers can be detected in the blood. Recommended cancer screening tests such as colonoscopy or mammograms are commonly used and have been shown to reduce cancer deaths. The Galleri test is intended to be used in addition to and not replace these tests. Missing recommended screening or ignoring symptoms could lead to a delayed diagnosis of cancer. Ask your healthcare provider about what cancer screening tests are right for you.
All individuals who receive a Cancer Signal Detected result on their Galleri test receive a phone call from a healthcare provider to explain the results and ensure the employee has a primary care physician (PCP) with whom the results can be shared. A GRAIL patient advocate can connect the the individual’s PCP with expert peer-to-peer consultation services regarding next steps for diagnostic testing. If they do not currently have a PCP, the patient advocate will provide them with local, in-network primary care navigation support. Once a PCP is found, the patient advocate can provide connections to expert peer-to-peer physician support and conducts ongoing follow-up with the individual to confirm the appropriate next steps are taken towards diagnostic evaluation.
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.
- U.S. Preventive Services Task Force (USPSTF) grades A,B,C recommended cancer screening tests. https://uspreventiveservicestaskforce.org/uspstf/topic_search_results
- Siegel RL et al. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763.
- Hubbell E, et al. Modeled reductions in late-stage cancer with a multi-cancer early detection test. Cancer Epidemiol Biomarkers Prev. 2021;30(3):460-468. DOI: doi.org/10.1158/1055-9965.EPI-20-1134
- Analysis of MarketScan claims database completed by GRAIL, Inc., July 2022. Data on file GA-2022-0085.
- Reddy SR, et al. Cost of cancer management by stage at diagnosis among Medicare beneficiaries. Curr Med Res Opin. 2022;38(8):1285-1294. DOI: doi.org/10.1080/03007995.2022.2047536.