A Multi-Cancer Approach to Early Detection

Current cancer screening guidelines are organ-specific and focused on finding individual types of cancer, including breast, cervical, colorectal and lung cancers.1These single-cancer screening tests are recommended because they have been shown to decrease cancer-specific mortality for the specific cancers they detect. However, cancer types that are individually less common in the general population and do not have screening tests are in aggregate responsible for ~70% of cancer deaths in people 50 years and older.2,3
New screening tests that can detect multiple types of cancer, before symptoms develop, are needed to give people a better chance of improved outcomes. These tests are intended to be used alongside the currently recommended single-cancer screening tests to help find more cancers earlier.

GRAIL has developed a multi-cancer early detection (MCED) test that detects a common signal shared across multiple types of cancer. This signal is based on methylation patterns in circulating cell-free DNA present in the blood and indicates that a cancer may be present. When a cancer signal is detected, in those eventually diagnosed with cancer, GRAIL’s MCED test also predicts the origin of the cancer with high accuracy.

Learn more about early detection, Galleri, and the science behind Galleri:

1. Cancer screening methods recommended by United States Preventive Services Task Force (USPSTF) A and B ratings. www.uspreventiveservicestaskforce.org.

2. Assumes screening is available for all prostate, breast, cervical, and colorectal cancer cases and 43% of lung cancer cases (based on estimated proportion of lung cancers that occur in screen-eligible individuals older than 40 years).

3. Estimated deaths per year in 2022 from American Cancer Society Cancer Facts and Figures 2022. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2022/2022-cancer-facts-and-figures.pdf. Data on file GA-2021-0065.

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Who is Eligible to Enroll in the PATHFINDER 2 Study?

The PATHFINDER 2 Study is a prospective, multi-center study in which approximately 20,000 participants will be tested with GRAIL’s multi-cancer early detection test. The study is currently open to men and women aged 50 years or older who meet eligibility criteria and receive care at participating health systems. Participants of previous or ongoing GRAIL sponsored studies are not eligible to participate in the PATHFINDER 2 Study.

Participating healthcare providers will be asked to identify potential participants to enroll in the PATHFINDER 2 Study, may be responsible for explaining test results to participants, and will be expected to help coordinate any follow-up testing for those participants who require subsequent diagnostic evaluation.

About the PATHFINDER 2 Study