What is Multi-Cancer Early Detection?
Multi-cancer early detection (MCED) is a new way of screening for multiple types of cancer early through blood-based testing. The vast majority of cancers show no symptoms until later stages, when treatment options may be limited. MCED aims to identify individuals with cancer at the earliest stages, before the cancer has spread and when the cancer can be treated with better outcomes.
What is the Galleri Test?
GRAIL's Galleri® test is a MCED next-generation sequencing (NGS)-based screening test looking for more than 50 shared cancer signals.1 It is used to detect the earliest signals of cancer, and further testing is then needed to confirm a cancer diagnosis. A positive result of the Galleri test does not mean a positive cancer diagnosis, but does indicate that evaluation for cancer should be conducted.
My Test Came Back with a Cancer Signal Detected, What Does It Mean?
The Galleri test detected a signal associated with a potential cancer diagnosis. This result will also include one or two predictions of where in the body the cancer may be coming from.
This result means that further diagnostic testing is needed to confirm a diagnosis.
My Test Shows No Cancer Signal Detected, What Does It Mean?
The Galleri test looked for a cancer signal and did not find one.
This result does not completely rule out the possibility of cancer. Not all cancers can be detected in the blood.
Important Reminders for All Results:
- Galleri is a screening test and does not diagnose cancer. Diagnostic testing is needed to confirm cancer.
- The Galleri test looks for active cancer and does not predict your future genetic risk for cancer.
- The Galleri test detects a shared signal across more than 50 types of cancer. Not all cancers can be detected in the blood.
- False positives and false negatives do occur.
I Received A Positive Cancer Signal, What Is Next?
- Connect with your nurse navigator!
- You and your navigator will review your cancer risk factors including your family history and will provide information on what to expect during your diagnostic work up.
- The navigator will work closely with your physician and office staff to ensure timely coordination of the appropriate follow-up diagnostic testing.
- Additional testing ordered by your physician may include but is not limited to:
- Lab work
- Imaging
- Biopsy/Surgery
- Referral to additional specialists
- Learn more about cancer diagnosis
We Are Here for You, Every Step of Your Journey.
Your nurse navigator will:
- Advocate and support you during your diagnostic journey
- Closely collaborate with your physician
- Answer questions and educate you on how to prepare for your tests and procedures
- Coordinate timely office visits across medical specialists when needed
- Facilitate communication between all members of healthcare team
- Identify and decrease barriers to care by linking to local and national resources
- Be available during normal business hours virtually via phone, text, and email based on your preference
Frequently Asked Questions
No, the Galleri test does not determine your genetic or future risk of developing cancer.
In a large case control study, the Galleri test detected a shared cancer signal common in more than 50 cancer types across all stages of cancer. See the comprehensive list.
The Galleri test is a screening test, not a diagnostic test. The Galleri test has a high specificity of 99.5% and predicts the cancer signal origin with 89% accuracy. However, false positives can occur, and the cancer signal origin may be called incorrectly in rare instances. It is important to follow up with diagnostic testing to confirm the presence of cancer.
Credit card (American Express, Visa, Mastercard and Discover) or e-check can be used to pay for the test online at paymybill.grail.com, over the phone ((855) 775-3613) with the information provided on your statement, or by mailing a check payment to GRAIL, Inc. at the following address:
GRAIL, Inc.
Dept LA
25195 Pasadena, CA 91185-5195
In the memo line on the check include your billing statement number and detach the bottom of your billing statement and send it along with your payment. A flexible payment plan may also be available; contact our Billing Support Team for more information at (855) 775-3613.
The Galleri test does not result in a diagnosis of cancer, as any cancer signal the test detects is confirmed with follow-up testing. Taking the Galleri test itself should not impact insurance coverage.
The test does not measure your genetic risk of developing cancer in the future and is instead looking for the presence of cancer at the time your blood is drawn. You may develop cancer in the future. Your healthcare provider is the best person to determine when to take the Galleri test again as part of your routine screening based on any underlying risk factors.
Galleri is a registered trademark of GRAIL, LLC, and is manufactured by GRAIL.
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.
- 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 Jun 23:S0923-7534(21)02046-9. doi:10.1016/j.annonc.2021.05.806.