Now there’s a proactive tool to screen for cancer - Galleri®

Introducing Galleri — a multi-cancer early detection blood test

The Galleri test screens for a “fingerprint” of many of the deadliest cancers before they become symptomatic, including many of those with no recommended screening tests today.1,2,3

In a large clinical study, the Galleri test screened for a signal shared by 50+ types of cancer. 3 See a list of what the Galleri test screens for.

The Galleri test does not detect a signal for all cancers and not all cancers can be detected in the blood. The Galleri is a screening test and does not diagnose cancer. Diagnostic testing is needed to confirm cancer. False positive and false negative results do occur. The Galleri test should be used in addition to healthcare provider recommended screening tests.
 

Patient Compilation

The Galleri test does not detect a signal for all cancers and not all cancers can be detected in the blood. The Galleri is a screening test and does not diagnose cancer. Diagnostic testing is needed to confirm cancer. False positive and false negative results do occur. The Galleri test should be used in addition to healthcare provider recommended screening tests.
 

Why is early detection important?

Cancer often hides, with symptoms not appearing until later stages. The earlier that cancer is diagnosed, the greater the chance of successful treatment and survival.4,5

blue circle icons representing the 5 cancers with guideline recommended screenings (breast, cervical, colorectal, lung, prostate) plus the galleri logo

Today, doctors test individually for 5 specific cancers — colorectal, lung (for those at risk), breast, cervical, and prostate.

While these single-cancer screenings play an important role in detecting 5 specific cancers today,* nearly 70% of cancers have no recommended screening tests.1,2*

Almost 70

The Galleri test identifies DNA in the bloodstream shed by cancer cells and does not predict future genetic risk for cancer. Galleri is a screening test and does not diagnose cancer. Diagnostic testing is needed to confirm cancer.
 

*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).

Who is the Galleri test for?

The Galleri test is recommended for adults with an elevated risk for cancer, such as those ages 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.

How often should you take the Galleri test?

The Galleri test can be taken annually.8,9 Deadly cancers can develop at any time and progress quickly, sometimes in less than a year. Adding the Galleri test to recommended single-cancer screenings may help detect more cancers at an early stage (based on modeled data).8,9

Galleri is a test that identifies DNA shed by cancer cells and screens for cancer at the time of testing. The Galleri test is not a hereditary screening test and does not predict your future genetic risk for cancer.

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.

There are two ways to request the Galleri® test

The Galleri test is available by prescription only and must be ordered by a healthcare provider. You can request the test through your healthcare provider or online through an independent telemedicine provider.

Talk to your healthcare provider

At your next wellness visit, ask your healthcare provider about Galleri. Our discussion guide can help start the conversation.

OR

Request the test online


You can also request the Galleri test online through an independent telemedicine provider.

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. 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]
  2. US Preventive Services Task Force. A,B,C grade recommendations, cancer, screenings. [cited 2023 Oct 23]. https://www.uspreventiveservicestaskforce.org/uspstf/topic_search_results
  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. American Cancer Society. The cancer atlas. [Internet] Early detection. https://canceratlas.cancer.org/taking-action/early-detection/
  5. Etzioni R, Urban N, Ramsey S, et al. The case for early detection. Nat Rev Cancer. 2003 Apr;3(4):243-52. doi: 10.1038/nrc1041
  6. 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. GRAIL Data on File GR-2023-0098
  7. American Association for Cancer Research. Cancer progress report 2023. https://cancerprogressreport.aacr.org/progress/
  8. Patel A. Methylated DNA biomarkers and incident cancer in the American Cancer Society (ACS) Cancer Prevention Study-3 (CPS-3) cohort. American Society of Clinical Oncology (ASCO) Annual Meeting; 2023 Jun 2-6. https://meetings.asco.org/abstracts-presentations/218486
  9. Sasieni P, Clarke CA, Hubbell E. Impact of MCED screening interval on reduction in late-stage cancer diagnosis and mortality. European Society for Medical Oncology (ESMO) Virtual Congress [poster]; 2021 Sep 16-21.