Josh Ofman, MD, MSHS, president and chief medical officer of GRAIL, LLC, issued the following statement:
MENLO PARK, Calif., February 2, 2022 – “We applaud President Biden for reigniting the Cancer Moonshot and highlighting the critical role of early detection in achieving the ambitious, but attainable, goal of reducing the cancer death rate by at least 50 percent in the next 25 years. Improving quality of life for patients and survivors, while addressing inequities in access to cancer screening, diagnostics and treatment is a critical part of the plan. Importantly, the President’s plan recognizes that the rigorous study of multi-cancer detection blood tests, to date, has brought us to a crucial inflection point where detecting many cancers at once is now an essential pillar of any effort to end cancer as we know it today.”
“GRAIL is deeply committed to detecting cancer early when treatments are more effective and there is potential for cure. Recent research has estimated the impact of multi-cancer early detection (MCED) testing on the ability to find more cancer types, in earlier stages, potentially reducing cancer deaths. We stand ready to accelerate the President’s bold plan and believe that MCED tests will help make it possible.
“In partnership with preeminent cancer institutions across the country, we validated the science behind our MCED technology and, in 2021, introduced Galleri® as a prescription only test for adults with an elevated risk of cancer, including those age 50 and older. As a result, today, we can detect more than 50 types of cancer, including in early stages, using a simple blood draw, vastly expanding the benefits of screening to more cancers and more people. We look forward to continuing our evidence generation with scientific and clinical partners and engaging with policymakers and the cancer stakeholder community so that more Americans can benefit from this paradigm shift in early cancer detection.”
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 wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). 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 test can detect 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 www.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.