you found cancer early enough to make a difference
The prospective, return of results PATHFINDER study enrolled participants at least 50 years of age, with and without additional cancer risk and without clinical suspicion of cancer. Participants who received a “Cancer Signal Detected” result from an earlier version of the Galleri test underwent diagnostic evaluation to assess whether they had cancer. Later blood samples were reanalyzed with the Galleri test: 0.9% of participants had “Cancer Signal Detected” result. Of these, 43% had a confirmed cancer diagnosis (Positive Predictive Value, PPV). First or second Cancer Signal Origin (predicting cancer location) was accurate 88% of the time.8
In another clinical study that included participants with newly diagnosed cancer, 51.5% of these participants received a Cancer Signal Detected result (sensitivity) and a predicted Cancer Signal Origin across 50 different cancer types. The predicted Cancer Signal Origin (cancer location) was accurate 88.7% of the time. The study also included participants without cancer, 0.5% of these participants received a Cancer Signal Detected result (false positive).7,8
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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- Surveillance, Epidemiology, and End Results (SEER) Program (www.seer.cancer.gov) SEER*Stat Database: Incidence — SEER 18 Regs Research Data. Nov 2018 Sub. Includes persons aged 50 – 79 diagnosed 2006 – 2015. “Early/Localized” includes invasive localized tumors that have not spread beyond organ of origin. “Late/Metastasized” includes invasive cancers that have metastasized beyond the organ of origin to other parts of the body.
- Cancer Facts and Figures 2022 https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2022/2022-cancer-facts-and-figures.pdf
- Siegel RL, et al. Cancer Statistics, 2022. CA Cancer J Clin. 2021;71(1):7 – 33.
- 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). Source: Estimated deaths per year in 2022 from American Cancer Society Cancer Facts and Figures 2022. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2022/2022-cancer-facts-and-figures.pdf. Data on file GA-2021 – 0065.
- USPSTF Cancer Screening Recommendations Grade A, B, C.
- Klein EA, 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 – 1177. doi: 10.1016/j.annonc.2021.05.806.
- Amin MB, et al. (Eds). AJCC Cancer Staging Manual (8th edition). Springer International Publishing: American Joint Commission on Cancer; 2017
- Schrag D, McDonnall CH, Naduld L, et al. PATHFINDER: A Prospective Study of a Multi-Cancer Early Detection Blood Test. Ann Oncol. 2022;33(suppl_7; abstr 9030). 10.1016/annonc/annonc1061 Presentation at European Society of Medical Oncology (ESMO) Congress September 9 – 13, 2022; Paris, France.