The Galleri test is a multi-cancer early detection test that detects more than 50 types of cancer, many of which are not commonly screened for today, through a simple blood draw.

The Galleri test does not diagnose cancer and not all cancers may be detected in the blood.

The Galleri test is intended to be used in addition to, and not in place of, other cancer screening tests your healthcare provider recommends.

The Galleri test looks for signals present in the blood that may be associated with cancer at the time of your blood draw. If a cancer signal is detected, the results can point to where in the body the cancer signal is coming from with high accuracy to help your healthcare provider guide next steps.

The Galleri test detects a cancer signal across more than 50 types of cancer across all stages according to a clinical validation study (CCGA3*).

*Circulating Cell-Free Genome Atlas (CCGA) sub-study

While the Galleri test can detect a cancer signal across more than 50 types of cancer, not all cancers are detected in the blood.

Recommended routine cancer screening tests such as colonoscopy or mammograms have been shown to reduce cancer deaths.

The Galleri test is intended to be used in addition to and not in place of these tests and can help maximize the benefits of early cancer detection. Missing recommended screening or ignoring symptoms could lead to a delayed diagnosis of cancer.

Based on data from our studies, the Galleri test has shown a low false-positive rate of 0.5% (detects a cancer signal when no cancer is present). This means that in approximately 200 people tested, only 1 person would be expected to receive a false-positive result.

The Galleri test development was supported by one of the largest clinical study programs in genomic medicine, with over 20,000 participants at more than 140 clinical study sites, including the Cleveland Clinic, Dana-Farber Cancer Institute, Intermountain Healthcare, Mayo Clinic, Oregon Health and Science University, Sutter Health, and U.S. Oncology Network. 

No, the Galleri test has not been cleared or approved by the FDA. GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists (CAP). GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing. 

The Galleri test received FDA Breakthrough Device Designation in 2019. While breakthrough device designation does not signal FDA approval, it allows for expedited review of medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions and gives the device’s manufacturer access to expertise from the federal agency during the development. 

A healthcare provider from PWNHealth will review your request and clinical eligibility within one week.

If the PWNHealth provider approves your request, you will be shipped a Galleri collection kit* and receive an email confirmation with instructions for how to schedule your blood draw.

When your collection kit arrives, you can schedule a blood draw appointment at one of GRAIL’s partner labs. Test results will be ready in about two weeks after completing your blood draw.

*Please note, the test kit must remain unopened until your
blood draw appointment.

If your Galleri test request is approved and your collection kit has arrived, you can schedule a blood draw appointment with one of GRAIL’s partner labs at no cost to you.*

You may also call your ACCESS On-Demand Concierge team at 1 – 833-AHC-ACCESS (1−833−242−2223) TTY 711, at any time or day for assistance in finding a Quest lab near you. You will need a copy of your completed test request form and an unopened Galleri collection kit for your blood draw.

*Please note that completing your blood draw at a lab other than one of GRAIL’s partner labs will not be covered by this benefit.

You will receive the following items if your eligibility for the Galleri test is approved:

• A collection kit will be mailed to you within one week after your request is approved. Do not break the quality seal on the collection kit. It should be opened by the lab technician who draws your blood sample.
• A completed Test Requisition Form will be emailed to you from GRAIL. Remember to print the form and bring it to your appointment.

Please bring both of these items to your blood draw appointment.

The Test Requisition Form is the ordering form the provider completes to order the test for you. You will receive this document via an order confirmation email from GRAIL if the provider orders your test.

No preparation or fasting is required. 

Some lab technicians may ask if you have fasted (no eating or drinking), but this is not required for the Galleri test. 

Please do not break the quality seal on the collection kit – it should be opened by the lab technician who draws your blood sample.

Store the collection kit at room temperature until your blood draw appointment. The contents are sensitive to extreme temperatures. For example, avoid storing your collection kit in the trunk of your car.

Your next step is to schedule your blood draw at a GRAIL partner lab.

For questions, you can call GRAIL’s customer service team at 1-844−935−3256, available 8 am‑8 pm Pacific time.

The collection kit includes instructions for the lab technician, two tubes for the blood sample, and packing materials to ensure the sample is safely shipped to GRAIL.

Please do not break the quality seal on the collection kit. It should be opened by the lab technician who draws your blood sample.

Approximately 1.5 tablespoons (or about 20 mL) of blood in two tubes typically from a vein in your arm is needed for the Galleri test.

The lab technician who draws your blood will pack and ship your sample back to GRAIL for processing.

Your sample will arrive at GRAIL 1 to 2 business days after your blood draw.

It takes about 2 weeks after your blood draw to receive your test results from the PWNHealth provider that ordered your test.

If you no longer wish to receive your Galleri results, please contact PWNHealth to request a cancellation at gc@​pwnhealth.​com or 1−888−494−7333, 10am — 7pm Pacific time. 

If you are unable to reach PWNHealth or require further assistance, please contact GRAIL Customer Service at customerservice@​grail.​com or 1−844−935−3256, TTY 711, 8am — 8pm Pacific time.

This means that no cancer signal was found. However, not all cancers can be detected by the Galleri test. Continue with all routine screening tests that your healthcare provider recommends. Missing routine screenings or ignoring symptoms can lead to a delayed diagnosis of cancer.

PWNHealth also offers optional post-test counseling to discuss your result, which is included in your benefit.

This means that there is a suspicion of cancer, and additional tests are needed to see if you have cancer.

The Galleri test can point to where in the body the cancer is coming from with high accuracy to help your primary healthcare provider guide next steps. Your primary healthcare provider should order appropriate follow-up testing to confirm if cancer is present.

If a diagnostic evaluation after a ​“cancer signal detected” result with Galleri does not confirm cancer, members may be eligible for a complimentary retest with Galleri. 

The request for a retest must be placed by the healthcare provider managing the member’s diagnostic evaluation. The retest must be administered within 3 – 6 months after the initial Galleri test. To initiate a request for a re-test, please contact Alignment Health Plan by calling the ACCESS On-Demand Concierge team 1 – 833-AHC-ACCESS (1−833−242−2223), TTY 711, available 24/7.

The Galleri test detects cancer signals in blood and is not a diagnostic test. Additional tests ordered by your primary healthcare provider are needed to confirm if cancer is present. Additional tests may include blood work or imaging.

The Galleri test is looking for the presence of cancer at the time your blood is drawn, but you may develop cancer in the future. The test does not measure your risk of developing cancer in the future, and it does not detect all cancers.

Yes, when you request the test, you are given the option to enter your primary healthcare provider’s contact information. If you select to share your results with your primary healthcare provider, your results will automatically be shared if a cancer signal is detected. 

We will not automatically share a ​“No Cancer Signal Detected” result with your primary healthcare provider even if you have provided contact information, but we encourage you to share it with your primary healthcare provider. 

The provider that orders the test will receive your test results and share them with you. Your test results and medical information are confidential, and access is limited to individuals who need the information for a specific purpose.

For example:

• If a cancer signal is detected, your test result will be shared with your primary healthcare provider (if you gave their contact information) so they can guide your next steps
• If a cancer signal is detected, you can consent to share your test results with Alignment Health Plan so they can consult with your primary healthcare provider and specialists, and advise on standard diagnostic care pathways

Alignment Health Plan will receive a list of members who order a Galleri test. Individual test results will not be shared with your health plan without your consent. During the test request process, you may provide consent for your health plan to receive your test results, which will help your health plan with the authorization and care coordination process.