Your provider will review your test request and clinical eligibility. The provider will approve your request and order the test if appropriate.

Through a simple blood draw, the Galleri multi-cancer early detection test detects a cancer signal shared by more than 50 types of cancer, many of which are not commonly screened for today.

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

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

The Galleri test looks for a signal 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 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.

Family history is one of many risk factors associated with cancer development. Other risk factors include age, eating habits, lifestyle, living or working environments, genetics, and many others**.

** https://training.seer.cancer.gov/disease/cancer/risk.html

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

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

The Galleri test detects a cancer signal shared by more than 50 types of cancers, however not all cancers can be detected in the blood. Recommended routine cancer screening tests such as colonoscopy or mammogram have been shown to reduce cancer deaths.

The Galleri test is intended to be used in addition to and not to 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 one 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.

No preparation or fasting is required.

The test uses approximately 1.5 tablespoons (or about 20 mL) of blood in two tubes, typically from a vein in your arm.

Your sample will arrive at the lab one to two business days after your blood draw. Your results should be available to the ordering provider who ordered your test within 10 business days (Monday — Friday, excluding holidays) from the time your sample is received at GRAIL.

You will receive your results about two weeks after your blood draw from the ordering provider.

If you no longer wish to receive your Galleri results, please contact GRAIL Customer Service at customerservice@grail.com or 833−694−2553.

This means that no cancer signal was found in your blood test. 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.

This means that there is a suspicion of cancer and additional tests are needed to see if you have cancer. The provider who ordered your test will share next steps as appropriate.

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

Galleri is a screening test that detects a cancer signal in blood. When a signal is detected, the Galleri test also predicts where in the body the signal is coming from.

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

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.

The request for a re-test must be placed by the healthcare provider who will order the re-test. The re-test must be administered within 3 – 6 months after the initial Galleri test. To initiate a

request for a re-test, the healthcare provider managing your diagnostic evaluation should contact GRAIL Customer Service at 833-MY-GALLERI (833−694−2553) or customerservice@grail.com.

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.

The healthcare 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, such as the ordering provider and a GRAIL Patient Advocate. The ordering provider will help you understand your test results and determine your next steps. A GRAIL Patient Advocate can also provide post-positive test result support for diagnostic workup, benefits connectivity, assistance, and support with continuity of care / payer coverage assistance.

For example, if a cancer signal is detected, your test result may be shared with your primary healthcare provider so they can be aware and involved with your next steps.

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