GRAIL and Ochsner Health Launch New Initiatives to Improve Cancer Detection Rates in Louisiana

Largest Gulf South Health System Will Offer GRAIL’s Galleri^® Multi-Cancer Early Detection Test to Patients at Risk for Cancer

Multi-Cancer Early Detection Health Equity Demonstration Three-Year Program Aims to Improve Cancer Outcomes Among Underserved Populations and Develop Best Practices for Deployment of Innovative Technologies in Community Settings

Ochsner Health to Begin Enrolling Participants in GRAIL’s PATHFINDER 2 Clinical Study

GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, and Ochsner Health (Ochsner) today announced a multi-faceted partnership to improve cancer detection rates in Louisiana using Galleri^®, GRAIL’s multi-cancer early detection (MCED) blood test. Ochsner, through a collaboration between its Ochsner Cancer Institute and Precision Medicine program, will offer the Galleri test by prescription to eligible patients in Louisiana to advance the delivery of cancer care.

The partnership includes the launch of a MCED Health Equity Demonstration Program, an initiative to improve cancer detection rates for underserved populations in Louisiana and to develop a model for deployment of innovative technologies in community settings. In addition to deploying Galleri, the initiative includes identification of educational and access gaps and barriers to cancer screening, co-creation and development of patient education materials, and community outreach to improve awareness and education about early cancer detection. Utilization of GRAIL’s REFLECTION registry program and other Ochsner data will evaluate the impact of the three-year program, with results to be published following the program’s conclusion.

“Unfortunately, Louisiana has some of the nation’s highest cancer death rates, but we are making strides every year in identifying cancers early through screenings,” said Brian Moore, MD, FACS, medical director, Ochsner Cancer Institute. “For those cancers that are historically not diagnosed quickly, offering Galleri to our patients will be revolutionary.”

More than 600,000 people die from cancer each year in the U.S., including more than 9,600 in Louisiana, 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. Recommended screening tests save lives, but only cover five cancer types in the U.S.: breast, colon, cervical, prostate, and, in high-risk adults, lung. In fact, 71% of cancer deaths have no recommended early detection screening.

“This partnership with GRAIL reinforces and aligns with our Healthy State initiative, a 10-year commitment to improving the overall health of the state, which includes collaborations and continued investment in the health of our communities,” said Warner Thomas, president and CEO, Ochsner Health. “Through this partnership, we have an opportunity to take a key step toward our goals by addressing an important health equity issue in Louisiana and supporting more than 7,500 underserved patients who visit our community centers.”

In a clinical study, the Galleri test demonstrated the ability to detect a shared signal from more than 50 types of cancer, as defined by the American Joint Committee on Cancer Staging Manual, over 45 of which lack recommended screening tests today. GRAIL’s Galleri test has a false positive rate under 1% and it can predict where cancer originated with 89% accuracy.

“We are excited to join forces with Ochsner in this effort as both organizations have a shared vision for increasing early cancer detection and a focus on improving outcomes in underserved communities,” said Bob Ragusa, chief executive officer at GRAIL. “By jointly launching a real-world evidence program to evaluate the impact of Galleri, we can not only help make a difference for underserved populations, but also collect critical insights that will help us develop a best-practice roadmap for integrating MCED testing that can be scaled and brought to other communities, helping to bridge the health equity gap in cancer detection.”

Ochsner’s academics and research team will also begin enrolling participants aged 50 years and older who are not actively being evaluated or treated for cancer in the ongoing PATHFINDER 2 study. This is a prospective, multi-center interventional study of the Galleri test that aims to enroll 20,000 participants through healthcare systems in North America. Participants who have a “cancer signal detected” test result will undergo a targeted diagnostic evaluation based on predicted cancer signal origin(s) through the Ochsner Cancer Institute to determine if cancer is present.

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 dated 29 October 2021.

For more information, please visit www.grail.com.

About Galleri^®

The earlier that cancer is detected, the higher the chance of successful outcomes. The Galleri multi-cancer early detection (MCED) test can detect signals 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 www.galleri.com.

About Ochsner Health

Ochsner Health is an integrated healthcare system with a mission to Serve, Heal, Lead, Educate and Innovate. Celebrating 80 years in 2022, it leads nationally in cancer care, cardiology, neurosciences, liver and heart transplants and pediatrics, among other areas. Ochsner is consistently named both the top hospital and top children’s hospital in Louisiana by U.S. News & World Report. The not-for-profit organization is inspiring healthier lives and stronger communities. Its focus is on preventing diseases and providing patient-centered care that is accessible, affordable, convenient and effective. Ochsner Health pioneers new treatments, deploys emerging technologies and performs groundbreaking research, including over 700 clinical studies. It has more than 34,000 employees and over 4,500 employed and affiliated physicians in over 90 medical specialties and subspecialties. It operates 40 hospitals and more than 300 health and urgent care centers across Louisiana, Mississippi and the Gulf South; and its cutting-edge Connected Health digital medicine program is caring for patients beyond its walls. In 2021, Ochsner Health treated more than 1 million people from every state and 75 countries. As Louisiana’s top healthcare educator, Ochsner Health and its partners educate thousands of healthcare professionals annually. To learn more, visit https://www.ochsner.org/.

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.

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“We are excited to join forces with Ochsner in this effort as both organizations have a shared vision for increasing early cancer detection and a focus on improving outcomes in underserved communities,” said Bob Ragusa, chief executive officer at GRAIL.