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Grail Announces Enrollment of First Patients in REACH Cancer Trial

Posted on by angelo
Grail Announces Enrollment of First Patients in REACH Cancer Trial

The Reach study, which stands for Real-world Evidence to Advance Multi-Cancer Early Detection Health Equity, is a three-year study that will compare up to 50,000 Medicare beneficiaries. Credit: Shutterstock / JHVEPhoto

US healthcare company Grail has announced the first patients enrolled in its REACH Medicare study to examine the company’s multi-cancer diagnostic test on social care beneficiaries, with the company touting its goal of bringing together underrepresented communities.

The Reach study, which stands for Real-world Evidence to Advance Multi-Cancer Early Detection Health Equity, is a three-year study that will compare up to 50,000 Medicare beneficiaries who received usual care plus an annual Galleri test.

The study (NCT05673018) is designed to measure the clinical impact of the Galleri test to assess the reduction in cancers diagnosed at stage IV and the safety associated with the use of Galleri. The company also added that the study is being conducted under an Investigational Device Exemption (IDE) application approved by the U.S. Food and Drug Administration (FDA) and approval of the study by the Centers for Medicare and Medicaid Services for Medicare coverage.

Josh Ofman, President of Grail, said, “The first participant enrolled in the REACH study marks an important milestone for GRAIL and its quest to increase access to the Galleri test for early, asymptomatic cancer detection. With approximately 80% of deaths caused by cancers that do not receive recommended screening tests, the Galleri test is a proactive tool to look for a ‘fingerprint’ of many of the deadliest cancers, many of which go undetected until symptoms appear.”

“The REACH study demonstrates our ongoing commitment to generating meaningful clinical information that is representative of the intended patient population, including groups that are often underrepresented in clinical research. The results of this study will add to our robust body of clinical evidence evaluating the potential of breakthrough medical devices in cancer detection, particularly in diverse populations.”

The announcement follows a study published by the US National Institutes for Health (NIH) which found that nearly 70% of people who died of cancer last year in the US were aged 65 and over, while more than half of all diagnoses were in people on the US Medicaid system.

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The announcement comes after biotech company Illumina was forced to spin off Grail following complaints from the European Commission over how the company was acquired. It also comes after Grail completed the planned enrollment of more than 35,000 subjects for its PATHFINDER 2 study.