Grail announced the enrolment of the first participant in the REACH/Galleri-Medicare study, which aims to evaluate the clinical impact of the Galleri multi-cancer early detection (MCED) test on the Medicare population.
The enrolment took place at Community Health Network, a central Indiana-based integrated healthcare system that encompasses over 200 sites of care.
Galleri, a blood test, is designed to detect a signature indicative of numerous deadly cancers that typically lack recommended screening and are often only identified when symptoms manifest.
The REACH study is focused on enrolling participants, particularly from historically underrepresented communities, including seniors and individuals from diverse racial and ethnic minority groups, as well as those from socioeconomically disadvantaged and rural areas.
REACH expands to real-world evidence to advance multi-cancer early detection health equity.
The three-year study will compare outcomes for up to 50,000 Medicare beneficiaries who receive their usual care plus an annual Galleri test to a control group receiving usual care without the blood test, across up to 50 study sites.
It will measure the clinical impact by evaluating the reduction in diagnosed stage IV cancers, the safety of using Galleri, and health care resource utilisation for cancer diagnostic workup in the Medicare population.
Grail president Josh Ofman said: “With approximately 80% of deaths caused by cancers lacking recommended screening tests, the Galleri test is a proactive tool to screen for a ‘fingerprint’ of many of the deadliest cancers, many of which go undetected until symptoms appear.
“The REACH study demonstrates our continued commitment to generate important clinical information that is representative of the intended patient population, including groups that are often underrepresented in clinical research.
“The findings from this study will add to our robust body of clinical evidence evaluating the potential for MCEDs to change the future of cancer detection, including in diverse populations.”
The study is conducted under an investigational device exemption (IDE) application approved by the US Food and Drug Administration (FDA), with the Centers for Medicare and Medicaid Services approving the study for Medicare coverage.
Consequently, Medicare will cover the costs of the Galleri test and related routine services received as part of the study.
