GRAIL, Inc. (Nasdaq: GRAL), a healthcare company renowned for its mission to detect cancer early when it can be effectively treated, has announced a significant milestone in its pursuit of advancing early cancer detection. The first participant has been enrolled in the groundbreaking Real-world Evidence to Advance Multi-Cancer Early Detection Health Equity (REACH/Galleri-Medicare) study at Community Health Network, an integrated healthcare system in central Indiana with over 200 care sites.

This pioneering study is designed to evaluate the clinical impact of the Galleri multi-cancer early detection (MCED) test among Medicare beneficiaries. Given that age is a major risk factor for cancer, and Medicare beneficiaries are at increased risk, the study focuses on providing early detection tools to this high-risk population. The REACH study aims to address a critical unmet need for early cancer detection among seniors and historically underrepresented communities.

The REACH/Galleri-Medicare study will span three years and involve up to 50,000 Medicare beneficiaries. Participants will be divided into two groups: one receiving usual care plus an annual Galleri test, and a comparator group receiving usual care without the Galleri test. This design will allow researchers to compare outcomes between those who use the Galleri test and those who do not.

Key objectives of the study include evaluating the reduction in diagnosed stage IV cancers and assessing the safety and healthcare resource utilization associated with Galleri use. The study is conducted under an Investigational Device Exemption (IDE) approved by the U.S. Food and Drug Administration (FDA), and it has received approval for Medicare coverage from the Centers for Medicare and Medicaid Services (CMS). As a result, Medicare will cover the costs of the Galleri test and related services for study participants.

Dr. Patrick McGill, M.D., Executive Vice President, Chief Transformation Officer, and Principal Investigator of the REACH study at Community Health Network, expressed enthusiasm about the study: “We are excited about the REACH study and the work that GRAIL is doing to detect cancer early when it is more likely to be successfully treated. As a health network committed to exceptional care for patients, it was important for Community Health Network to participate in the REACH study. We really want to expand upon and understand the real-world evidence of the Galleri test.”

The REACH study places a strong emphasis on health equity by including historically underrepresented groups, including seniors, racial and ethnic minorities, and socioeconomically disadvantaged populations. This approach aims to provide a more comprehensive understanding of the Galleri test’s impact across diverse patient populations.

Josh Ofman, MD, MSHS, President at GRAIL, highlighted the importance of the study: “The first participant enrolled in the REACH study marks a significant milestone for GRAIL and its pursuit of broad access to Galleri for asymptomatic, early cancer detection. 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/Galleri-Medicare study represents a major step forward in cancer detection, particularly for Medicare beneficiaries who are at high risk due to age. By integrating the Galleri MCED test into routine care and focusing on underrepresented populations, GRAIL, Inc. aims to improve early cancer detection and patient outcomes. The results of this study are expected to contribute valuable insights into the effectiveness of multi-cancer early detection tools and their potential to transform cancer care.

Key Points:

– GRAIL, Inc. announces the enrollment of the first participant in the REACH/Galleri-Medicare study at Community Health Network.

– The study aims to evaluate the Galleri multi-cancer early detection (MCED) test’s effectiveness among Medicare beneficiaries, particularly focusing on underrepresented communities.

– The research will involve up to 50,000 participants and is conducted under FDA Investigational Device Exemption (IDE) and Medicare coverage approvals.

– The study addresses a critical need for early cancer detection in Medicare beneficiaries, who face higher cancer risks due to age.

  Community Health Network, Early Cancer Detection, early cancer screening, FDA IDE approval, Galleri, Galleri multi-cancer test, GRAIL, GRAIL REACH study, health equity in cancer care, Healthcare Innovation, Medicare, Medicare cancer detection, multi-cancer early detection, REACH Study