Go further with cancer screening

We can now treat cancer far more effectively, but we can’t treat what we haven’t found. And while doctors can test individually for 5 specific cancers today, more than 70% of cancer deaths are caused by cancers without recommended screening tests.1,2*

*Assumes screening is available for all prostate, breast, cervical, and colorectal cancer cases and 43% of lung cancer cases (based on the estimated proportion of lung cancers that occur in screen-eligible individuals older than 40 years).

Now there’s a proactive tool to screen for cancer

The Galleri test can be taken annually as a simple blood test and screens for a “fingerprint” of many of the deadliest cancers before they become symptomatic, including those with no recommended screening tests today.1,2,3

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.

Galleri Studio Amelia White Product 8745

Who is the Galleri test for?

The Galleri test is recommended for adults with an elevated risk for cancer, such as those age 50 or older.

  • The Galleri test is available by prescription only.

  • Use of the Galleri test is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment.

Age is the biggest risk factor for cancer. Adults over age 50 are 13 times more likely to have cancer compared to people under the age of 50.4

Certain factors, in addition to age 50+, further increase cancer risk5:

  • Diabetes
  • Obesity (BMI ≥ 30)
  • Current or previous smokers
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We collaborated with leading cancer institutes to study the Galleri test:

Supported by robust clinical data, the Galleri test has been studied in multiple clinical trials with over 20,000 participants.3,6

Text reading: "GRAIL collaborated with leading cancer institutes to study the Galleri test" followed by logos for the Cleveland Clinic, Dana-Farber Cancer Institute, Memorial Sloan Kettering Cancer Center, Intermountain Healthcare, Icahn School of Medicine at Mount Sinai, Sutter Health, UHN Princess Margaret Cancer Centre, Benoroya Research Institute Virginia Mason, Sarah Cannon, Hartford HealthCare Cancer Institute, The US Oncology Network, Knight Cancer Institute, The Christ Hospital Lindner Research Center

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.

  1. US Preventive Services Task Force. A,B,C grade recommendations, cancer, screenings. [cited 2023 Oct 23]. https://www.uspreventiveservicestaskforce.org/uspstf/topic_search_results

  2. American Cancer Society Cancer Facts and Figures 2023. Available at: http://www.cancer.org/content/.... GRAIL, Inc. Data on file GA-2021-0065

  3. 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 Sep;32(9):1167-77. doi: 10.1016/j.annonc.2021.05.806

  4. Surveillance, Epidemiology, and End Results (SEER) Program SEER*Stat Database: Incidence - SEER Research Limited-Field Data, 21 Regs, 2020 Nov Sub (2000-2018) - Linked To County Attributes - Time Dependent (1990-2018) Income/Rurality, 1969-2019 Counties, National Cancer Institute, DCCPS, Surveillance Research Program, released 2021 Apr, based on the 2020 Nov submission. [Risk Factor Data on file: American Cancer Society Cancer Prevention Studies II/III.]

  5. American Association for Cancer Research. Cancer progress report 2023. https://cancerprogressreport.aacr.org/progress/

  6. 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