Collaboration to Encourage Awareness of First-of-its-kind Galleri^® Multi-Cancer Early Detection Blood Test

GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, has partnered with PGA TOUR Champions player David Duval and World Golf Hall of Famer Juli Inkster to raise awareness about multi-cancer early detection (MCED) and encourage people at an elevated risk of cancer, including those aged 50 or older, to speak with their doctor about the Galleri^® test, which screens for a signal shared across more than 50 types of cancer through a simple blood draw and can detect a cancer signal even before symptoms appear.

Duval—a former World No. 1 golfer, 13-time PGA TOUR winner and TV analyst—decided to take the Galleri test to take proactive care of his health as he moved into the next chapter of his life. He will play in the inaugural Galleri^® Classic, a PGA TOUR Champions tournament held March 20-26, 2023 at the Mission Hill Country Club in Rancho Mirage, Calif. Proceeds from the tournament will support local, cancer-related nonprofit organizations focused on underserved populations.

“Now that I’m in my 50s, I know I need to go further to take care of my health. I’m aware of all the things that can happen in life – including a cancer diagnosis – so adding the Galleri test to my standard cancer screens enabled me to be proactive,” said Duval. “I would encourage anyone over 50 to talk to their doctor to see if Galleri is right for them.”

Inkster, an LPGA and World Golf Hall of Fame member, won 31 times on the LPGA TOUR, including seven major championships, and has personal experience with cancer.

“My dad was a firefighter and a painter who recently passed away after battling late-stage esophageal and liver cancer. Early detection might have allowed us to get him on an appropriate treatment sooner,” said Inkster. “We have made significant advances in cancer diagnosis and treatment over the past few decades, but cancer still takes far too many lives. Early detection could be a game changer.”

“We are honored to collaborate with David and Juli to raise awareness about MCED and encourage those with an elevated risk of cancer, as well as individuals over the age of 50, to take a more proactive role in screening for cancer,” said Bob Ragusa, Chief Executive Officer at GRAIL. “By partnering with these accomplished athletes who share personal experiences with cancer and are passionate about building authentic discussions around health, we hope to make a meaningful difference in the lives of people at elevated risk for cancer.”

More than 609,000 people are expected to die from cancer in 2023, according to the American Cancer Society. This is in part because the majority of cancers are found too late when the cancer has spread, and treatment is less likely to be successful. 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, about seven in 10 cancer deaths are from cancers that lack recommended screenings.

In a clinical study, the Galleri test demonstrated the ability to detect a shared cancer signal across more than 50 types of cancer—over 45 of which lack recommended screening tests today, with a low false positive rate of less than 1%. When cancer is detected, Galleri can determine the cancer signal origin with high accuracy, enabling more targeted diagnostic evaluation. The Galleri test requires a prescription from a licensed healthcare provider and should be used in addition to recommended cancer screenings.

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, please 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 healthcare 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 “No Cancer Signal 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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