The Galleri test is a qualitative, next-generation sequencing-based, in vitro diagnostic test intended for the detection of DNA methylation patterns using cell-free DNA (cfDNA) isolated from human peripheral whole blood. DNA methylation is a natural process used by cells to regulate gene expression. Certain DNA methylation patterns can serve as a signal of cancer and provide information about the origin of the cancer signal.
The Galleri test detects methylation patterns of cell-free DNA (cfDNA) that could indicate the presence of cancer. When a cancer signal is detected, the test predicts the origin of the cancer signal with high accuracy. The Galleri test does not detect specific genetic mutations and does not determine an individual’s genetic risk for cancer. Learn more about the Galleri test.
A review of the results from the CCGA sub-study (CCGA3) which included 2,823 cancer participants and 1,254 non cancer participant controls showed the Galleri test detected cancer signals across 50+ cancer types (defined by AJCC). The Galleri test report includes the 24 cancer classes and the associated sensitivity of the test with each cancer class. Cancer class is based on the combination of the primary cancer site and the pathologic diagnosis. See our clinical evidence.
The Galleri test should be used in addition to guideline-recommended cancer screening, such as mammography, colonoscopy, prostate specific antigen (PSA) or cervical cancer screening. Galleri can benefit patients with an elevated risk of cancer due to age, such as those aged 50 or older.
The Galleri test is not intended to replace guideline-recommended cancer screening tests. One of the most pressing unmet needs in early cancer detection is to identify cancers for which there are no existing recommended screening tests. Galleri is designed to detect many cancer types, including those that lack routine screenings. The United States Preventive Services Task Force (USPSTF) currently recommends screening paradigms for lung (for high-risk smokers), breast, cervical, prostate, and colorectal cancers.
Using the Galleri test alongside existing cancer screening programs, such as mammograms and colonoscopies, is expected to increase early cancer detection. In addition to detecting many cancers that lack recommended screenings, the Galleri test may also find cancers missed during routine screening, cancers in individuals who were non-adherent to current cancer screening tests, cancers that occurred during screening intervals, or cancers that occurred in individuals who lack access to existing screening tests.
The Galleri test can only be ordered by a licensed healthcare provider. This may include physicians, nurse practitioners, or physician’s assistants.
The Galleri test is not currently included in cancer screening guidelines.
With Galleri, annual screening provides the opportunity to detect more cancers early. It is up to the patient’s healthcare provider to determine the appropriate screening interval based on the individual’s underlying risk factors.
The Galleri test is only commercially available in the US at this time. The Galleri test will be available to eligible patients as part of a clinical study in partnership with the United Kingdom’s National Health Service (NHS) in mid-2021. More details provided here.
The Galleri test is not currently covered by insurance.
Patients can pay for the test online with all major credit cards (American Express, Visa, Mastercard, and Discover) or with an e‑check. Additionally, payment can be made over the phone by calling GRAIL Billing Support at 855−775−3613 or by mailing a physical check to GRAIL, Inc. at the address provided below:
Dept LA 25195
Pasadena, CA 91185 – 5195
Contact your account representative to learn more about the payment options that are relevant for your patients.
For a patient paying out-of-pocket (patient self-pay), credit card information is required on the paper Test Requisition Form (TRF). If the order is submitted electronically via the Provider Portal, the patient will receive an email and/or phone call from GRAIL to collect payment information once the sample is received in the laboratory. If the payment cannot be processed by the time the test results are available, the patient will receive a bill by mail at the address provided in the TRF.
Patients should check with their HSA/FSA account administrator or insurance company to determine eligibility.
Specimen requirements include:
1. Specimen Type: Human Whole Blood
2. Container: Streck cfDNA BCTⓇ Blood Collection Tubes
3. Volume: 10mL x 2 tubes
4. Sample Storage: Ambient temperature, not to extend beyond the 6 ‑37℃ range
5. Stability: 7 calendar days (168 hours)
Specimen rejection criteria include:
1. Tubes other than the Streck Cell-Free DNA BCT Blood Collection Tubes
2. Less than 3mL of whole blood per collection tube
3. Unlabeled specimens
4. Severely damaged or dangerously packaged specimens
5. Specimens submitted or stored at temperature outside of 6 — 37°C
6. Collection date greater than 7 days prior to the start of processing
7. Specimens resulting in grossly hemolyzed plasma.
Collection kits should be stored at room temperature. Avoid storing the collection kits in places that experience high or low temperatures.
No, the Galleri test blood draw requires no preparation or fasting by the patient. Fasting for other blood draws will not affect the Galleri test results if blood is drawn at the same time.
Test results should be available within 10 business days from the date the sample arrives at GRAIL’s laboratory. Typically, a sample will arrive at the laboratory in 1 to 2 business days after the blood sample is shipped.
In the rare scenarios where a sample fails, you will be notified about your sample’s status. At this time a new expected report date will be provided.
The Galleri test results are shared with the ordering healthcare provider via the online Provider Portal or via automatic fax notifications. An email notification will be sent to the ordering provider when new test result reports are ready in the Provider Portal.
The Galleri test did not detect DNA methylation signals associated with cancer in the analyzed cell-free DNA obtained from the patient’s blood sample. This does not exclude the presence of cancer. Individuals should be advised to continue participating in all recommended cancer screening options at appropriate intervals. If signs and symptoms arise, timely clinical evaluation by qualified health care professionals is recommended.
The Galleri test detected DNA methylation signals associated with cancer in the analyzed cell-free DNA obtained from the patient blood sample. Diagnostic evaluation for cancer should be conducted to determine if the patient has cancer. A “Cancer Signal Detected” result is not a diagnosis of cancer.
The Galleri test is a screening test, not a diagnostic test. It is important to follow up with diagnostic testing to confirm the presence of cancer.
The “predicted signal origin(s)” is/are provided to help guide the diagnostic evaluation needed to confirm the presence of cancer. In some instances, the top predicted signal origin may be called incorrectly. In cases when two top signal origins are returned, the first signal origin may be incorrect while the second one may be correct. In some cases both the first and second signal origins may be incorrect.
When the Galleri test detects a cancer signal the report also includes the top predicted cancer signal origin(s). The results of the Galleri test must be confirmed by diagnostic tests in accordance with standard medical practice. These results should be interpreted in the context of the individual’s clinical risk factors. Diagnostic decisions are the responsibility of the treating physician. When a cancer signal is detected, even after a negative diagnostic evaluation of the Cancer Signal Origin(s), the likelihood that the individual has cancer remains elevated and may warrant further evaluation. You may contact GRAIL Customer Service at 833−694−2553 or email@example.com to connect with Clinical Support Services.
This could mean that the individual has a cancer that is difficult to identify by the selected follow up diagnostic procedures, or that the result of the Galleri test is a false positive and that the individual does not have cancer. Testing was insufficient to detect cancer, including due to the cancer being located in a different part of the body. Healthcare providers should use their independent clinical judgment for patient diagnosis, treatment, and care. For more information, you may GRAIL Customer Service at 833−694−2553 or firstname.lastname@example.org.
A test may be cancelled for a variety of reasons, which include healthcare provider or patient requests, exceeding the specimen stability window, and failure to meet data quality requirements, among others. For more information on your specific cancellation, please contact Customer Service at 833−694−2553 or email@example.com.
The Galleri test results report does not report incidental findings.