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Galleri® Test
The breakthrough technology that can detect 50+ cancers with a single blood test.
Go further withcancer screening
Galleri® is a first-of-its-kind multi-cancer early detection test that looks for a signal shared by 50+ types of cancer with just two vials of blood.*
Call To Order Today*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 can occur. This test is highly recommended in conjuction with a Full Body MRI screening.
What is the Galleri test?
Galleri redefines what's possible. Only 5 cancers have recommended screening tests in the United States. Using Galleri in addition to these tests can increase the chance of finding cancer early, to allow for earlier treatment.
With a single blood test, Galleri screens for a signal shared by multiple cancers that would otherwise go unnoticed. If a cancer signal is detected, Galleri predicts the tissue type or organ associated with the cancer signal with 88% accuracy* to help guide follow-up diagnostic testing which may include lab work or imaging to confirm cancer.
*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.
How does the test work?
All cells in your body, including cancer cells, release DNA fragments into the bloodstream when they complete their life cycle and die. These fragments are known as cell-free DNA.1 The Galleri test screens your blood sample for cell-free DNA and identifies whether it comes from healthy or cancer cells.2
DNA from cancer cells has specific methylation patterns that identify it as a cancer signal. Methylation is a natural process that can change the activity of DNA. Methylation patterns also contain information about the tissue type or organ associated with the cancer signal.3
How Galleri Saves Lives
It detects a signal shared by deadly cancers that lack recommended screenings
These deadly cancers tend to release more cell-free DNA into the bloodstream at early stages, are responsible for two-thirds of cancer deaths, and are more likely to be detected by the Galleri test.1, 4
The Galleri test looks for a signal associated with active cancer and does not predict future genetic risk for cancer.
Detection of a signal shared by multiple types of cancer with a single blood test2
Galleri screens for a signal shared by more than 50 cancer types with a single blood test, most of which lack recommended screening tests.1,3 In a clinical study, Galleri approximately doubled the number of cancers detected with recommended screening.2 Galleri goes beyond routine cancer screenings (breast, lung - for those at risk, colon, cervical, and prostate) to screen for additional cancers, such as stomach and pancreatic.1,3
Galleri is a screening test and does not diagnose cancer. Diagnostic testing is needed to confirm cancer. The Galleri test does not detect a signal for all cancers and not all cancers can be detected in the blood.
Highly accurate prediction of the tissue type or organ associated with the cancer signal
The predicted Cancer Signal Origin (CSO) helps guide next steps to confirm cancer. With a Cancer Signal Detected result, Galleri predicts one or two Cancer Signal Origins. This prediction offers information about the tissue type or organ associated with the cancer signal. There are 21 possible Cancer Signal Origins. In patients with a confirmed cancer diagnosis following a Galleri Cancer Signal Detected result, the test was accurate 88% of the time in predicting the first or second Cancer Signal Origin.2 If the predicted Cancer Signal Origin does not result in a cancer diagnosis it could mean the cancer could not be detected or is in another location.
Low False Positive Rate
The false positive rate is the proportion of people without cancer who receive a "Cancer Signal Detected" result.
The Galleri test has a 0.5% false positive rate, meaning 1 in 200 people who do not have cancer will receive a "Cancer Signal Detected" result.1,2 This helps minimize the chances that an individual without cancer receives a "Cancer Signal Detected" result, and therefore can help minimize unnecessary diagnostic procedures to confirm cancer.
False positive and false negative results do occur.
Understanding Your Results
You will receive your test result about two weeks after your blood sample is received at the GRAIL lab.
There are two possible results:
- No Cancer Signal Detected
- Cancer Signal Detected
Galleri looks for a cancer signal shared by more than 50 cancer types.2 You will not receive a list of the 50+ types of cancer and a result for each one.
If Galleri detects a cancer signal, your result will include one or two Cancer Signal Origins which predict the tissue type or organ associated with the cancer signal.
Cancer Signal Detection Sensitivity
Galleri redefines what's possible. Only 5 cancers have recommended screening tests in the United States. Using Galleri in addition to these tests can increase the chance of finding cancer early, to allow for earlier treatment.
Liver/Bile-duct
93.5%
Head and Neck
85.7%
Esophagus
85.0%
Pancreas
83.7%
Ovary
83.1%
Colon/Rectum
82.0%
Anus
81.8%
Cervix
80.0%
Urothelial Tract
80.0%
Lung
74.8%
Plasma Cell Neoplasm
72.3%
Gallbladder
70.6%
Stomach
66.7%
Sarcoma
60.0%
Lymphoma
56.3%
Other
50.8%
Melanoma
46.2%
Lymphoid Leukemia
41.2%
Bladder
34.8%
Breast
30.5%
Uterus
28.0%
Myeloid Neoplasm
20.0%
Kidney
18.2%
Prostate
11.2%
Thyroid
0.0%
Request Galleri Today
Pair Galleri with your Reveal Scan for greater peace of mind, or order it a la carte. What's important is that you're being proactive about early detection and taking control of your health.
Galleri Multi-Cancer Test
$999
Call To OrderDetect 50+ cancers in your body as early as Stage 1, with just two vials of blood.
Your test kit will be sent to your home with everything you need to schedule your draw, including a pre-paid label to send it back to the lab for analysis. Your test results will come directly from Galleri.
Galleri FAQs
The Galleri test is a multi-cancer early detection test that screens for a signal shared by more than 50 types of cancer, many that lack recommended screening through a simple blood test. Galleri is a screening test and does not diagnose cancer and not all cancers may be detected in the blood. Diagnostic testing is needed to confirm cancer.
Easy! Call us at 833-320-1091 to order your test today.
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 multiple cancers. If a cancer signal is detected, results from the test predict the tissue type or organ associated with the cancer signal to help your healthcare provider determine next steps.
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.
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.
In a clinical study, Galleri detected a signal shared by over 50 types of cancer — including some fast-spreading and aggressive cancers responsible for approximately two-thirds of cancer deaths. Galleri is a cancer screening test, meaning it looks for cancer before symptoms appear. The Galleri test does not detect a signal for all cancers and not all cancers can be detected in the blood.Based on clinical study data, the test's sensitivity varies across different cancers (and stages). You can find sensitivity information for 24 cancer classes at: https://www.galleri.com/hcp/galleri-test-performance
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%)
No, the Galleri test is not a genetic risk assessment. A genetic risk assessment is a one time only measurement and assesses your future risk of developing cancer. The Galleri test looks for a signal associated with active cancer at the time of your blood draw. Genetic tests may look at DNA and assess lifelong risk for cancer but cannot detect if a person currently has cancer. Our goal is for Galleri to be a annual cancer screening test. By regularly using the Galleri test alongside recommended cancer screenings, you can increase your chance of finding cancer early.
References
1. 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.
2. Liu MC, Oxnard GR, Klein EA; et al. for CCGA Consortium. Sensitive and specific multi-cancer detection and localization using methylation signatures in cell-free DNA. Ann Oncol. 2020;31(6):745-759. DOI:https://doi.org/10.1016/j.annonc.2020.02.011.
3. Thierry A, El Messaoudi S, Gahan P, et al. Origins, structures, and functions of circulating DNA in oncology. Cancer Metastasis Rev. 2016;35:347–76. DOI:https://doi.org/10.1007/s10555-016-9629-x.
4. 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.
5. US Preventive Services Task Force. Recommendations Cancer. Accessed 7Mar2023.https://www.uspreventiveservicestaskforce.org/uspstf/topic_search_results.