Grail enrolls first participant in study of Galleri multi-cancer detection test

Grail announced that the first participant has been enrolled in the REACH/Galleri-Medicare study at Community Health Network, an integrated healthcare system in central Indiana with more than 200 sites of care. The study is a first-of-its-kind real-world evidence study designed to further evaluate the clinical impact of the Galleri multi-cancer early detection test in Medicare beneficiaries. The study aims to enroll participants with a specific focus on inclusion of historically underrepresented communities, including seniors and people across diverse racial and ethnic minority groups, as well as socioeconomically disadvantaged and rural populations. The three-year study seeks to compare up to 50,000 Medicare beneficiaries who have received usual care plus an annual Galleri test with a comparator arm of beneficiaries who receive usual care without a Galleri test, across up to 50 study sites. The study is being conducted under an Investigational Device Exemption application approved by the FDA, and the Centers for Medicare and Medicaid Services’ approval of the study for Medicare coverage.