Grail Galleri Multi-Cancer Test

This test is for cancer screening purposes only. A Cancer Signal Detected result is not a cancer diagnosis and requires follow-up diagnostic testing. A No Cancer Signal Detected result does not rule out cancer. This test should complement, not replace, standard cancer screening. Results must be reviewed with a qualified healthcare provider. This panel does not constitute medical advice.

Why early detection matters

Cancer risk increases with age, regardless of family history. Only 5 to 10% of cancers are inherited; the remaining 90 to 95% arise from environmental exposures, lifestyle, and aging-related changes in DNA. Adults over 50 are 13 times more likely to develop cancer than those under 50.

Many cancers show no symptoms in early stages. Standard screenings (colonoscopy, mammogram, PSA) each cover one cancer type. For cancers like pancreatic, ovarian, and liver, there is currently no recommended early screening protocol.

Early detection expands treatment options. This is what the Galleri test is designed to do.

About the Galleri test

Most cancer screenings focus on one cancer at a time. Colonoscopies screen for colorectal cancer. Mammograms screen for breast cancer. PSA tests screen for prostate cancer. But many of the cancers that are hardest to survive (pancreatic, ovarian, liver, esophageal) have no standard early screening test.

The Galleri test is a multi-cancer early detection (MCED) blood test developed by GRAIL. A single blood draw screens for signals associated with more than 50 types of cancer, including many that currently have no routine screening protocol. It is designed to be used alongside, not instead of, existing cancer screening.

How the test works

Cancer cells shed fragments of DNA into the bloodstream. These fragments carry chemical markers, called methylation patterns, that function like a fingerprint unique to cancer cells. The Galleri test uses advanced DNA sequencing and machine learning to analyze these patterns across more than one million sites in a sample of your blood.

If a signal is detected, the test also provides a Cancer Signal Origin (CSO): a prediction of the tissue type or organ where the signal may be coming from. This prediction guides the next step, which is confirmatory diagnostic testing (such as imaging or a biopsy) to determine whether cancer is present.

Cancers the Galleri test screens for

The Galleri test screens for signals associated with more than 50 types of cancer, including many that currently have no recommended standard screening.

Among the cancers it covers are some of the hardest to detect early through other means:

• Pancreatic cancer
• Ovarian cancer
• Liver and bile duct cancer
• Esophageal cancer
• Lung cancer
• Head and neck cancers
• Lymphoma
• Stomach cancer
• Bladder cancer
• Colorectal cancer
• Plasma cell neoplasm (multiple myeloma)
• Anal cancer

The test also covers additional cancer types including breast, cervical, prostate, and kidney cancers, among others.

Sensitivity varies by cancer type and stage. The Galleri test does not detect all cancers. A No Cancer Signal Detected result does not mean cancer is absent.

How the Galleri test fits with existing screening

The Galleri test is designed to add a layer of detection, not to replace standard cancer screening protocols. Mammograms, colonoscopies, PSA tests, and Pap smears remain important parts of routine preventive care. The Galleri test extends coverage to cancers that those protocols do not screen for, and provides a single-draw screen across cancer types simultaneously.

If you are due for any standard cancer screenings, those should continue alongside the Galleri test.

Who benefits from testing

The Galleri test is primarily recommended for adults 50 and older. It may also be appropriate for adults with elevated cancer risk factors, including:

• A significant family history of cancer
• Certain genetic variants associated with cancer risk
• A history of prior cancer

Superpower members who include the Galleri test in their annual health program gain a layer of cancer surveillance that covers types their other biomarker panels do not screen for.

The Galleri test is not recommended for:

• Pregnant individuals
• Adults under 22 years old
• Those currently undergoing active cancer treatment

If you fall into any of these categories, speak with a healthcare provider before ordering.

What a Cancer Signal Detected result means

A Cancer Signal Detected result does not mean you have cancer. It means the test detected patterns in your blood that may be associated with cancer, and that follow-up diagnostic testing is warranted.

The result includes a Cancer Signal Origin (CSO): a prediction of the tissue type or organ the signal may be coming from. This guides the type of confirmatory testing your provider will recommend, typically imaging and potentially a biopsy.

In the PATHFINDER study, approximately 62% of participants with a Cancer Signal Detected result were confirmed to have cancer on follow-up. This means that some positive signals are not confirmed. Your Superpower care team will support you in understanding your result and navigating next steps.

What a No Cancer Signal Detected result means

A No Cancer Signal Detected result is the result most people receive. In GRAIL's PATHFINDER study, approximately 99% of participants aged 50 to 79 received this result.

A No Cancer Signal Detected result does not mean cancer is definitively absent. The test does not detect all cancers, and sensitivity varies by cancer type and stage. Routine standard cancer screening should continue regardless of your Galleri result.