Early cancer detection is critical
Many cancers stay hidden until it is too late. The deadliest cancers are typically “silent” until they’ve spread to other parts of the body. Late-stage cancers are more difficult to treat and typically have worse outcomes.1
We can’t treat what we can’t find. Finding cancer in early stages improves overall 5-year survival rates from ~20 to 90%.2 It is now possible to treat many cancers effectively even at Stage III, but only if we find them in time.3
Current cancer screening has a huge gap
We routinely screen for about four cancers (colon, breast, cervical, and lung); 86% of cancers are not caught by today’s standard tests.4,5
Single-cancer screenings are an important tool for diagnosis of a handful of cancer types, but most cancer deaths are due to cancers with no recommended screening tests.4,6
7 in 10 cancer deaths come from cancers that lack recommended screening, including pancreatic, liver, ovarian, esophageal and others.4,6
Multi-cancer early detection screening from a blood test
Multi-cancer early detection (MCED) testing is a new approach to screening for cancer. Adding a blood-based multi-cancer early detection test can help screen for many of the deadliest cancers that don’t have recommended screening today.7,8
The Galleri® multi-cancer early detection test
The Galleri test is a multi-cancer early detection (MCED) blood test that screens for cancers before they become symptomatic, including those we don’t have recommended screening tests for today.9
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 should be used in addition to healthcare provider recommended screening tests.
The Galleri test delivers results you can trust as the only available MCED test with demonstrated performance in patients being screened for cancer.* Galleri can detect 50+ cancer types, with high sensitivity for many of the deadliest cancers in early stages**, and it predicts the Cancer Signal Origin (CSO) with high accuracy to guide an efficient diagnostic work-up.7,9
*The Galleri test’s key performance metrics were derived from the outcomes of an interventional clinical study of patients presenting for screening without clinical suspicion of cancer, a study population that reflects the intended use population.
**7 of 12 cancers that account for 2/3 of US cancer deaths have a stage I-II sensitivity of greater than or equal to 50%.
Learn more about the Galleri test
Find out moreThe Galleri test is recommended for use in adults with an elevated risk for cancer, such as those age 50 or older. The test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. The Galleri test is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of the test 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.
References
1. American Cancer Society. The cancer atlas. [Internet] Early detection. https://canceratlas.cancer.org/taking-action/early-detection/
2. Surveillance, Epidemiology, and End Results (SEER) Program SEER*Stat Database: Incidence - SEER 18 Regs Research Data, 2018 Nov Sub. Includes persons aged 50-79 diagnosed 2006-2015. [GRAIL, LLC. Data on file: GA-2021-004]
3. If cancer is detected early, it is more amenable to curative treatment. Cancer treatment is based on the stage of the cancer. Sometimes, treatment is meant to cure the cancer. Other times, the goal is to stop the cancer from spreading further (CDC, https://www.cdc.gov/cancer/survivors/patients/treatments.htm).
4. US Preventive Services Task Force. A,B,C grade recommendations, cancer, screenings. [cited 2023 Oct 23]. https://www.uspreventiveservicestaskforce.org/uspstf/topic_search_results
5. NORC at the University of Chicago Cancer Detection Tool: https://cancerdetection.norc.org/
6. American Cancer Society. Cancer Facts & Figures 2022. https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2022.html [GRAIL, LLC. Data on file: GA-2021-0065]
7. 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.
8. American Cancer Society. Lifetime Risk of Developing or Dying From Cancer. https://www.cancer.org/cancer/risk-prevention/understanding-cancer-risk/lifetime-probability-of-developing-or-dying-from-cancer.html.
9. Schrag D, Beer TM, McDonnell CH, et al. Blood-based tests for multi-cancer early detection (PATHFINDER): a prospective cohort study. Lancet. 2023;402:1251-1260. doi: 10.1016/S0140-6736(23)01700-2