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Galleri Studio Amelia White Product 8745

The 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

  1. 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: 10.1016/j.annonc.2021.05.806
  2. Hackshaw A, Clarke CA, Hartman AR. New genomic technologies for multi-cancer early detection: rethinking the scope of cancer screening. Cancer Cell. 2022;40(2):109-13. doi: 10.1016/j.ccell.2022.01.012
  3. 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):745-59. doi: 10.1016/j.annonc.2020.02.011
  4. Schrag D, Beer TM, McDonnell CH, et al. Blood-based tests for multicancer early detection (PATHFINDER): a prospective cohort study. Lancet. 2023;402(10409):1251-60. doi: 10.1016/S0140-6736(23)01700-2
  5. Bredno J, Venn O, Chen X, et al. Circulating tumor DNA allele fraction: a candidate biological signal for multicancer early detection tests to assess the clinical significance of cancers. Am J Pathol. 2022;192(10):1368-78. doi: 10.1016/j.ajpath.2022.07.007
  6. Nabavizadeh N, McDonnell C, Kurbegov D, et al. Safety and performance of a multi-cancer early detection (MCED) test in an intended-use population: initial results from the registrational PATHFINDER 2 study [presentation]. European Society for Medical Oncology (ESMO) Congress; 2025 Oct 17-21; Berlin. https://assets.grail.com/wp-content/uploads/2025/10/ESMO-2025_PF2-Initial-Results_Presentation_FINAL-CLEAN-10.16.2025.pdf
  7. Patel AV. Methylated DNA biomarkers and incident cancer in the American Cancer Society (ACS) Cancer Prevention Study-3 (CPS-3) cohort [presentation]. American Society of Clinical Oncology (ASCO) Annual Meeting; 2023 Jun 2-6; Chicago. https://assets.grail.com/wp-content/uploads/2023/06/Patel_ASCO-2023_ACS-CPS-3-Biobank_oral-presentation_FINAL.pdf
  8. Sasieni P, Clarke CA, Hubbell E. Impact of MCED screening interval on reduction in late-stage cancer diagnosis and mortality [poster]. European Society for Medical Oncology (ESMO) Virtual Congress; 2021 Sep 16-21. https://assets.grail.com/wp-content/uploads/2021/09/ESMO_Screening_Interval_Poster_G_Final_Submitted.pdf
  9. American Cancer Society. Cancer facts & figures 2025. https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/2025-cancer-facts-figures.html [GRAIL, Inc. Data on file: GA-2021-0065]
  10. US Preventive Services Task Force. A,B,C grade recommendations, cancer, screening [cited 2025 Mar 18]. https://www.uspreventiveservicestaskforce.org/uspstf/topic_search_results
  11. Patel AV, Deubler E, Teras LR, et al. Key risk factors for the relative and absolute 5-year risk of cancer to enhance cancer screening and prevention. Cancer. 2022;128(19):3502-15. doi: 10.1002/cncr.34396
  12. SEER*Explorer. Incidence Data, 22 Registries, Nov 2023 Sub (1975-2021). Surveillance Research Program, National Cancer Institute; 2024 Apr 17. https://seer.cancer.gov/statistics-network/explorer/ [GRAIL, Inc. Data on file GR-2021-0067]
  13. American Cancer Society. Cancer facts & figures 2025. https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/2025-cancer-facts-figures.html
  14. Cong Z, Ye X, Kurian AW. Elevated cancer risk among individuals with combinations of cancer-related risk factors: A large claims database analysis [poster]. American Society of Clinical Oncology (ASCO); 2023 Jun 2-6. https://grail.com/wp-content/uploads/2023/06/Cong_ASCO-2023_Elevated-Risk-Subgroup-Optum_Poster_FINAL.pdf
     

*Based on the first ~25,000 participants with 1 year of follow-up.

†Assumes screening is available for all prostate, breast, cervical, and colorectal cancer cases and 46% of lung cancer cases (based on the estimated proportion of lung cancers that occur in screen-eligible individuals older than 40 years).