Galleri^® in the Medicare Population

Studies have shown that older individuals experience a greater burden of cancer due to higher mortality rates compared to younger individuals. The REACH study is a clinical study to learn how the Galleri® multi-cancer early detection (MCED) test can screen for cancer through a simple blood draw. Led by GRAIL, the purpose of this study is to understand the real-world clinical value, benefit and safety of the Galleri test in the Medicare eligible patient population.

The trial will evaluate if using the Galleri test alongside existing usual medical care can help find cancer early and to see if the Galleri test decreases the number of late stage cancer diagnoses. Evaluating the Galleri test in Medicare recipients will provide important data on the potential harms and benefits of MCED screening in older individuals.

About the REACH study

The REACH/Galleri-Medicare study is sponsored by GRAIL and will enroll approximately 50,000 Medicare beneficiaries who have received usual care plus a Galleri test with a matched comparator arm of beneficiaries who receive usual care alone. The REACH study is being conducted under the U.S. Food and Drug Administration’s (FDA) approval of an investigational device exemption (IDE) application. More information about the REACH Study is available on clinicaltrials.gov.

In the REACH study, the Galleri test is an investigational test with associated risks and benefits that are described in the study materials. Risks of the test include, but are not limited to, false-positive results (a cancer signal detected when cancer is not present), false-negative results (no cancer signal detected when cancer is present), and incorrect prediction of the origin of a cancer signal. The Galleri test should not replace any guideline-recommended screenings or other standard of care diagnostic or treatment options.