The Galleri® Test:
The first clinically-validated MCED test
Introducing the Galleri® test
Galleri is a multi-cancer early detection (MCED) test that looks for a signal shared by more than 50 types of cancer through a simple blood draw. Most of these cancers have no recommended screening and often go unnoticed until symptoms appear. Adding the Galleri test to recommended cancer screening increases the chance of early cancer detection and may lead to successful treatment.
Galleri Named to TIME´s Best inventions of 2022
Why is early detection important?
The Galleri test can increase your chance of finding a signal associated with cancer early, when used in addition to single cancer screenings.
Only 5 recommended cancer screening tests exist today:
breast, colorectal, lung (for those at risk), cervical, and prostate
About 3 out of 4 new cancer cases and cancer-related deaths
will be due to cancers with no recommended screening.
The Galleri test looks for a signal associated with active cancer and does not predict your future genetic risk for cancer.
How does Galleri test work?
Every time you take the test, Galleri checks more than 100,000 DNA regions and over a million specific DNA sites to screen for a signal shared by 50+ cancers at the time of your blood draw. If a cancer signal is detected, results from the test can predict the tissue type or organ associated with the cancer signal.
Who is Galleri for?
Age is the biggest risk factor for cancer. In fact, adults over age 50 are 13 times more likely to have cancer compared to people under the age of 50*. Cancer risk increases for everyone as they age regardless of family history—only 5% to 10% of cancers are inherited.
The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older.
References:
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:https://doi.org/10.1016/j.annonc.2021.05.806.
US Preventive Services Task Force. Recommendations Cancer. Accessed 7Mar2023. https://www.uspreventiveservicestaskforce.org/uspstf/topic_search_results.
Schrag D, McDonnall CH, Naduld L, et al. PATHFINDER: A Prospective Study of a Multi-Cancer Early Detection Blood Test. Presentation at European Society of Medical Oncology (ESMO) Congress September 9-13, 2022; Paris, France.
Hubbell E, Venn O, Shanmugam A. Shared Cancer Signal: Evidence from Cross-Training. Presentation at USC Computational Biology Symposium; May 19-21, 2022; Los Angeles, CA.
Surveillance, Epidemiology, and End Results (SEER) Program (www.seer.cancer.gov) SEER*Stat Database Incidence - SEER Research Limited-Field Data, 21 Registries, Nov 2020 Sub (2000-2018) - Linked To County Attributes -Time Dependent (1990-2018) Income/Rurality, 1969-2019 Counties, National Cancer Institute, DCCPS, Surveillance Research Program, released April 2021, based on the November 2020 submission. Risk Factor Data on file: American Cancer Society Cancer Prevention Studies II/III.
NIH/National Cancer Institute. Genetic testing for inherited cancer susceptibility syndromes. Accessed 3Mar2023. https://www.cancer.gov/about-cancer/causes-prevention/genetics/genetic-testing-fact-sheet.
American Cancer Society. Cancer Facts & Figures 2022. Atlanta: American Cancer Society; 2022 https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2022.html. Data on file GA-2021-0065.
FAQ´s
“I feel like this test was made for me and I appreciated so much. I´m going to be able to live my life because we found it so soon”
Valerie
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A “Cancer Signal Detected” result is expected in approximately 1% or 1 out of 100 Galleri tests in people over 50 years of age.
In a recent clinical study, on average, 4 out of 10 people with a "Cancer Signal Detected" result received a cancer diagnosis with diagnostic testing, and 1 out of 200 people without cancer received a "Cancer Signal Detected" result.
(Positive Predictive Value was 43% and False Positive rate was 0.5%)
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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 is intended to be used in addition to, and not replace, other cancer screening tests your healthcare provider recommends.
Use of Galleri is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment.
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Cancer risk increases for everyone as they age regardless of family history—only 5% to 10% of cancers are inherited.
Age is the biggest risk factor for cancer. In fact, adults over age 50 are 13 times more likely to have cancer compared to people under the age of 50. Talk to your provider about your risk for cancer, and whether the Galleri test is right for you.