Collaboration Will Evaluate Multi-Cancer Early Detection Screening With the Galleri^® Test to Increase Cancer Detection in Underserved Populations

Whitman-Walker Institute, a leader in LGBTQ health, research, education and policy with special expertise in HIV care; Cancer Support Community (CSC), a global nonprofit that works to ease the burdens of cancer and eliminate barriers to care through individual and community support, education, and advocacy; and GRAIL, LLC, a healthcare company whose mission is to detect cancer early, when it can be cured, today announced a research collaboration aimed at advancing health equity in cancer screening and care with Galleri^Ⓡ, a multi-cancer early detection (MCED) test, in diverse patient populations. The Implementation and Navigation of Cancer Liquid biopsy to Understand Diverse Patient Experiences (INCLUDE) study will evaluate established community outreach strategies intended to build awareness and increase early cancer screening. Outreach will be focused on groups that have been historically underrepresented in clinical research and care.

As part of the collaboration, eligible individuals will be invited by Whitman-Walker to participate in this real-world study being undertaken in collaboration with Cancer Support Community. The study will assess the feasibility of implementing the Galleri^Ⓡ test in a real-world setting inclusive of diverse patient populations, including groups that bear a higher burden of cancer-related health disparities, such as racial and ethnic minorities and members of the LGBTQ community.

“We are excited about the opportunity to offer our communities access to MCED testing before it is widely covered by public and private insurers,” said Jonathon Rendina, PhD, MPH, Senior Director of Research at Whitman-Walker Institute and Principal Investigator on the study. “This pivotal study will promote access to the latest technology and enhance our understanding of the barriers we face to implementing these screenings within community healthcare settings. The pairing of navigation services with this first of its kind cancer screening can be easily implemented within community health settings, fulfilling our mission as front-line providers of holistic care and support. The screening and navigation services will foster equity and access for communities often left out of medical innovations that can be life-saving.”

GRAIL will provide support for the collaboration to Whitman-Walker, which will conduct outreach and enroll individuals into the study, inclusive of Galleri testing. For individuals who receive a Galleri cancer signal detected test result, Cancer Support Community will offer professionally-led support and navigation services, from diagnosis to treatment and survivorship.

“As part of our mission at CSC, we are dedicated to inspiring change that improves the cancer experience by engaging in research that sheds light on the realities of coping with a cancer diagnosis,” said Sally Werner, Chief Experience Officer at Cancer Support Community and Deputy Co-Chair of the MCED Consortium. “We believe MCED has the potential to transform cancer detection as we know it for people who are at higher risk of developing cancer. We are thrilled to collaborate with GRAIL and Whitman-Walker to assess best practices around incorporating MCED in community-based healthcare settings and identify barriers that prevent underserved and underresourced populations from getting screened.”

The Galleri test is a first-of-its-kind multi-cancer early detection test available for detection of a shared cancer signal across more than 50 cancer types that can be localized to specific tissues or organs to help clinicians focus their diagnostic evaluation.

“We are thrilled to announce this partnership with the Whitman-Walker Institute and Cancer Support Community to support MCED in underserved communities and gain important insights into what is most meaningful to people in terms of cancer screening,” said Jeffrey Venstrom, MD, Chief Medical Officer at GRAIL. “This is part of broader efforts to further evaluate the implementation of Galleri^Ⓡ in diverse and underserved communities to reduce cancer burden and pursue greater health equity.”

More than 609,000 people die from cancer each year in the U.S., according to the American Cancer Society. This is in large part because some of the deadliest cancers are found too late when outcomes are often poorer. Current recommended screening tests save lives, but only cover five cancer types in the U.S. which include: breast, colon, cervical, prostate, and lung (in high-risk individuals). In fact, about 71% of cancer deaths are from cancers that lack recommended early detection screening. Significant disparities exist in cancer incidence and outcomes. Black people in the U.S. face the highest cancer mortality rates of any population and people from communities of color face higher rates of late-stage diagnosis. Recent studies have also shown an elevated rate of cancer diagnosis for members of the LGBTQ community.

About Whitman-Walker Institute

Whitman-Walker Institute is one of the country’s premiere organizations focused on advancing the health and wellbeing of people facing barriers to quality care, particularly LGBTQ people and people living with HIV, through the strategic integration of clinical expertise, research acumen, quality education and policy change. The Institute endeavors to remain grounded in community by seeking feedback and promoting ideas that reflect the lived experiences and identified needs of those we serve. The Institute conducts cutting edge research to end the HIV epidemic, eliminates health disparities and promotes wellness and resiliency. Through such work, we empower all persons to live healthy, love openly and achieve equality and inclusion.

About Cancer Support Community

The Cancer Support Community is a global nonprofit that uplifts and strengthens people impacted by cancer. We are dedicated to fostering a community where people find connection, compassion, and knowledge. We provide professionally led support and navigation services, along with social connections and award-winning education— when, where and how impacted individuals prefer throughout their cancer experience. These resources are available at 190 Cancer Support Community, Gilda’s Club, and healthcare partner locations as well as online and over the phone —all at no cost. We amplify the voices of those impacted by cancer through research and advocacy and create solutions that break down barriers to care and close the healthcare gap for communities whose members are disproportionately affected by cancer. For more information, please visit www.cancersupportcommunity.org.

About GRAIL

GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC, is a subsidiary of Illumina, Inc. (NASDAQ:ILMN) currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission.

For more information, visit grail.com.

About Galleri^®

The earlier that cancer is detected, the higher the chance of successful outcomes. The Galleri multi-cancer early detection test can detect a shared cancer signal across more than 50 types of cancer, as defined by the American Joint Committee on Cancer Staging Manual, through a routine blood draw. When a cancer signal is detected, the Galleri test predicts the cancer signal origin, or where the cancer is located in the body, with high accuracy to help guide the next steps to diagnosis. The Galleri test requires a prescription from a licensed health care provider and should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate-specific antigen (PSA) test, or cervical cancer screening. It is intended for use in people with an elevated risk of cancer, such as those aged 50 or older.

For more information about Galleri, visit galleri.com.

Important Galleri Safety Information

The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older. The Galleri test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. Galleri is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of Galleri is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment.

Results should be interpreted by a healthcare provider in the context of medical history, clinical signs and symptoms. A test result of “Cancer Signal Not Detected” does not rule out cancer. A test result of “Cancer Signal Detected” requires confirmatory diagnostic evaluation by medically established procedures (e.g., imaging) to confirm cancer.

If cancer is not confirmed with further testing, it could mean that cancer is not present or testing was insufficient to detect cancer, including due to the cancer being located in a different part of the body. False-positive (a cancer signal detected when cancer is not present) and false-negative (a cancer signal not detected when cancer is present) test results do occur. Rx only.

Laboratory/Test Information

GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. The Galleri test was developed, and its performance characteristics were determined by GRAIL. The Galleri test has not been cleared or approved by the U.S. Food and Drug Administration. GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230823995059/en/