Screening for multiple cancers is now possible with Galleri®

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 is recommended to be used along with other cancer screening tests such as colonoscopy or mammogram.

In a clinical validation study (CCGA3*), the Galleri test detected more than 50 types of cancer across all stages.

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

The Galleri test detects more than 50 types of cancers, however not all cancers may be 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 replace 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 what is believed to be one of the largest clinical study programs in genomic medicine, with more than 20,000 participants at more than 140 clinical study sites, including the Mayo Clinic, Dana-Farber Cancer Institute, Cleveland Clinic, Sutter Health, Oregon Health & Science University, Intermountain Healthcare and U.S. Oncology Network.

The Galleri test has not been cleared or approved by the FDA. Galleri is a Laboratory Developed Test. 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 GRAIL clinical laboratory also holds a New York Department of Health Clinical Laboratory Evaluation Program (CLEP) permit.

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.

The cost for completing your blood draw at some place other than one of GRAIL’s partner labs will not be covered by this benefit; you will be responsible for payment.

Bring your unopened Galleri specimen collection kit and your completed and printed ​“Test Requisition Form” from PWNHealth to your blood draw appointment.

You will receive these 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 the ordering provider at PWNHealth. Remember to print the form and bring it to your appointment

The Test Requisition Form is the ordering form the provider at PWNHealth completes to order the test for you.

If the provider orders your test, you will receive this document in an order confirmation email from GRAIL.

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.

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

Your sample will arrive at GRAIL one to two business days after your blood draw.

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.

If you require further assistance, please contact GRAIL Customer Service at customerservice@grail.​com or 1−833−694−2553.

The Galleri test looked for a cancer signal in your blood sample and did not find one. A Galleri result of No Cancer Signal Detected does not rule out 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. This result does not predict whether you will develop cancer in the future. 

False negative results do occur. 

The Galleri test detected a signal often 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 to confirm cancer. GRAIL also offers patients and providers additional support and resources if needed to help guide next steps.

False positive results do occur.

If a diagnostic evaluation after a ​“cancer signal detected” result with Galleri does not confirm cancer, you may be eligible for a complementary re-test with Galleri even if you are within 12 months of your initial Galleri test.

The request for a re-test must be placed by the healthcare provider managing your diagnostic evaluation. The re-test 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.

A Cancer Signal Detected 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 to confirm cancer. GRAIL also offers patients and providers additional support and resources if needed to help guide next steps.

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; this will let the ordering PWNHealth provider share your Galleri test results automatically if a cancer signal is detected.

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

The provider who orders the test will receive your test result and share it with you. Your test result 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 when you requested the test) 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

Additional details about privacy and data use are included in the Galleri patient portal when you request the test (see: Galleri Patient Information Sheet).

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.