While doctors can screen individually for 5 specific cancers today, nearly 70% of deaths* are caused by cancers with no recommended screening tests.A,C
Now, there’s a proactive tool to screen for cancer — Galleri.** This multi-cancer early detection test is a simple blood test that can be taken annually. It screens for a “fingerprint” of many of the deadliest cancers before they become symptomatic.A,B
Cancers growing in the body shed DNA into the bloodstream, and although there are many types of cancer, the DNA fragments act like a unique “fingerprint” of cancer.A,D,E This provides direction to your doctor on the cancer’s origin and helps guide the next steps in diagnosis.***
*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).
** 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.
***In the PATHFINDER study, Cancer Signal Origin (CSO) prediction accuracy was 88% for participants with a cancer diagnosis among study participants with a Cancer Signal Detected test result.
The Galleri test is recommended for adults with an elevated risk for cancer, such as those age 50 or older.
Use of the Galleri test is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment.
It is intended to be used in addition to and not replace other cancer screening tests your healthcare provider recommends.
Talk to your provider about your risk for cancer and whether the Galleri test is right for you.
The Galleri test is a screening test for asymptomatic adults with an elevated risk for cancer, such as those aged 50 or older. Galleri detects a signal shared by multiple cancers; when a Cancer Signal is Detected, Galleri predicts Cancer Signal Origin to guide diagnostic evaluation.
The Galleri test looks for active cancer and does not predict future genetic risk for cancer. All cells in your body, including cancer cells, release DNA fragments into the bloodstream. These fragments are called cell-free DNA. The Galleri test screens your blood sample for cell-free DNA and identifies whether it comes from healthy or cancer cells. Cell-free DNA from cancer cells also contains information about the organ or tissue of origin. The process uses advanced technology and pattern recognition to detect a Cancer Signal and predict the Cancer Signal Origin. This information helps guide healthcare providers to perform a diagnostic evaluation for cancer.
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.
Galleri detects a signal shared by multiple cancers, in a clinical study, Galleri detected a signal shared by over 50 types of cancer —including some fast-spreading and deadly cancers responsible for approximately two-thirds of cancer deaths. 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.
Most people who take the Galleri test will receive a “No Cancer Signal Detected” result. A “Cancer Signal Detected” result is expected in approximately 1% of Galleri tests in people over 50 years of age. The Galleri test accuracy is measured through Positive Predictive Value and False Positive Rates.
Positive Predictive Value (PPV) is the probability that a person with a “Cancer Signal Detected” test result has cancer.A False Positive is a test result that indicates that a person has a specific disease or condition when the person actually does not have the disease or condition.In a recent study, the PPV was 43.1% for study participants with a Cancer Signal Detected result who were diagnosed with cancer. The False Positive Rate was 0.5% for participants without cancer. Galleri is a screening test and does not diagnose cancer. Diagnostic testing is needed to confirm cancer.No, Galleri is not a genetic risk assessment test. A genetic risk assessment is a one time measurement and assesses the future risk of developing cancer. Genetic tests may look at DNA and assess lifelong risk for cancer but cannot detect if a person currently has cancer.
The Galleri test looks for a signal associated with active cancer at the time of your blood draw. Regularly using the Galleri test, alongside recommended cancer screenings, can increase your chance of detecting cancer early.
No, the Galleri test is only commercially available in the US.
If you are currently a Carepoint patient in Hudson County who meets eligibility requirements, please ask your provider for Galleri at your next annual wellness visit / physical. For those patients with upcoming appointments, please speak with your provider. The blood will be drawn right in the office at the time of your visit. For any other questions please call your primary care office.
Learn more about how your sample is processed at the GRAIL laboratory by watching this video.
The trained technician who draws your blood will pack and ship your sample back to the GRAIL laboratory for processing. Everything needed to complete the blood and return the sample is within the Galleri kit.
If you or your blood draw technician has questions, please call Customer Service: (833) 694‑2553
No, fasting is not required for the Galleri test.
Approximately 1.5 tablespoons (or about 20 mL) of blood in two tubes from a vein in your arm.
If you no longer wish to receive your Galleri results, contact GRAIL Customer Service by calling 833−694−2553.
Your sample will arrive at the GRAIL lab one to two days after your blood draw. Test results will be available about two weeks after your sample is received at the GRAIL lab.
If you participated in an onsite blood draw sponsored by your employer results may take as long as three weeks.
Your test results can be requested by contacting GRAIL Customer Service by calling 833−694−2553.
The Galleri test detected a signal associated with cancer. This result will also include one or two predictions of the tissue type or organ associated with the cancer signal, called “Cancer Signal Origin.”
Results should be interpreted by a healthcare provider. This test result is not a cancer diagnosis and requires follow-up diagnostic testing which may include lab work or imaging ordered by your healthcare provider. GRAIL also offers patients and providers additional support and resources if needed to help guide next steps.
False positive and false negative results do occur.
The Galleri test looked for a cancer signal in your blood sample and did not find one. This result does not completely rule out the possibility of cancer. The Galleri test does not detect a signal for all cancers and not all cancers can be detected in the blood. Continue with routine cancer screenings your healthcare provider recommends.
A Galleri result of No Cancer Signal Detected does not rule out cancer.
The Galleri test is intended to be used in addition to, and not replace, other cancer screening tests your healthcare provider recommends. Single-cancer screening tests are recommended because they have been proven to save lives by detecting cancer early. Using Galleri in addition to recommended single-cancer screenings can increase your chances of detecting cancer early, to allow for earlier treatment.
Galleri does not detect a signal for all cancers and not all cancers can be detected in the blood.
A Cancer Signal Detected test result is not a cancer diagnosis. A Cancer Signal Detected result requires follow-up diagnostic testing which may include lab work or imaging ordered by your healthcare provider. GRAIL also offers patients and providers additional support and resources if needed to help guide next steps.
All results are automatically shared with the provider who ordered the test. When requesting the test, you may provide the information for your primary care provider.
If you would like us to fax your results to an additional healthcare provider, please contact Customer Service by calling 833−694−2553 to receive instructions on how to complete a results release form.
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.
GRAIL’s 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. GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes.
A. 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
B. Schrag D, Beer TM, McDonnell CH, et al. Blood-based tests for multi-cancer early detection (PATHFINDER)
C. US Preventive Services Task Force. A,B,C grade recommendations, cancer, screenings. [cited 2023 Oct 23]. https://www.uspreventiveservicestaskforce.org/uspstf/topic_search_results
D. Liu MC, Oxnard GR, Klein EA, et al. Sensitive and specific multi-cancer detection and localization using methylation signatures in cell-free DNA. Ann Oncol. 2020 Mar 30;31(6):745-59. doi: 10.1016/j.annonc.2020.02.011
E. Thierry AR, El Messaoudi S, Gahan PB, et al. Origins, structures, and functions of circulating DNA in oncology. Cancer Metastasis Rev. 2016 Jul 8;35:347–76. doi: 10.1007/s10555-016-9629-x
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CarePoint Health brings quality, patient-focused healthcare to Hudson County, New Jersey. Combining the resources of three area hospitals, Bayonne Medical Center, Christ Hospital in Jersey City, and Hoboken University Medical Center, CarePoint provides a new approach to deliver healthcare that puts the patient front and center.
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WHO WE ARE
CarePoint Health brings quality, patient-focused healthcare to Hudson County, New Jersey. Combining the resources of three area hospitals, Bayonne Medical Center, Christ Hospital in Jersey City, and Hoboken University Medical Center, CarePoint provides a new approach to deliver healthcare that puts the patient front and center.
© 2022 CarePoint Health. All rights reserved.
QUICK LINKS
GET TO KNOW US
RESOURCES
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