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Now you can detect a cancer signal across 50+ types of cancer with a simple blood draw1 Now you can detect a cancer signal across 50+ types of cancer with a simple blood draw1
Using cell-free DNA (cfDNA), the Galleri® test can detect a cancer signal and predict its origin.1 This revolutionary test will change the way we look at cancer, ushering in a new age of multi-cancer early detection (MCED) while complementing guideline-recommended screening.
Explore how you can discuss the benefits of the Galleri test with your patients.
Explore how you can discuss the benefits of the Galleri test with your patients.
Multi-Cancer Early Detection (MCED) has arrived
Fighting cancer starts with knowing it’s there.
~70% of cancer deaths* are caused by cancers without recommended screening.2
Potential to detect more cancers, early.
Using a multi-cancer early detection test alongside existing screening can help detect more cancers early.3
One blood draw can detect a cancer signal across 50+ types of cancer.1
When a cancer signal is detected, the test predicts the origin of the cancer signal with high accuracy.†
* For US population ages 50 – 79. Assumes screening is available for all prostate, breast, cervical, and colorectal cancer cases and 43% of lung cancer cases (based on estimated proportion of lung cancers that occur in screen-eligible individuals older than 40 years).
† In study participants with cancer. The Circulating Cell-free Genome Atlas (CCGA) Study (NCT02889978) sub-study (CCGA3) included cancer (n=2823) and
non-cancer (n=1254) participants. Specificity was 99.5% for noncancer participants. Sensitivity was 51.5% for cancer participants. Cancer Signal Origin
(CSO) prediction accuracy was 88.7% for cancer participants with a cancer signal detected.
Important Safety Information
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.
Laboratory / Test Information
GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists (CAP). 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. GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes.
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- 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. Jun 24, 2021. doi: 10.1016/j.annonc.2021.05.806.
- Estimated deaths per year in 2021 from American Cancer Society Cancer Facts and Figures 2021. Available at: http://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2021/cancer-facts-and-figures-2021.pdf. Data on file GA-2021 – 0065.
- Hackshaw A, Cohen SS, Reichert H, et al. Estimating the population health impact of a multi-cancer early detection genomic blood test to complement existing screening in the US and UK. Br J Cancer. 2021;125(10):1432 – 1442. doi: 10.1038/s41416-021 – 01498‑4.