MENLO PARK, Calif., – May 5, 2022 – GRAIL is excited to be named “Best Overall Medical Device Company” in the 2022 MedTech Breakthrough Awards. GRAIL is a healthcare company with the mission of detecting cancer early, when it can be cured. Our Galleri® test is the first of-its-kind multi-cancer early detection (MCED) test available in the U.S.
The MedTech Breakthrough Awards honor excellence and recognize innovation, hard work and success in a range of health and medical technology categories. This year’s program attracted more than 3,900 nominations from over 15 different countries throughout the world.
With a single blood draw, the Galleri test provides early detection insights that help patients and their physicians be proactive about their health. The revolutionary technology can detect cancer early, even before an individual is showing symptoms. In clinical studies, the Galleri test demonstrated the ability to detect a common cancer signal across more than 50 types of cancers – more than 45 of which currently have no screening options – and predict where the cancer signal originated in the body.
“Unfortunately, seven in ten of all cancer deaths are from cancers that lack recommended screening today and while current guideline-recommended screening tests save lives, they screen for just five cancers in the U.S.: breast, colorectal, cervical, prostate, and for high-risk smokers, lung,” said James Johnson, managing director, MedTech Breakthrough. “GRAIL is delivering a ‘breakthrough’ preventative approach with the Galleri test that enables the transition from screening for individual cancers, to screening individuals for over 50 types of cancers. The ability to detect cancer early, when cancer is often easier to treat, is a significant opportunity to reduce the burden of cancer. We extend our sincere congratulations to the GRAIL team for taking home our award for ‘Best Overall Medical Device Company’ award for 2022.”
GRAIL is partnering with leading health systems and employers to make the Galleri test accessible to eligible U.S. patients by prescription. Learn more about availability in the U.S. at Galleri.com. In addition, GRAIL has a partnership with the UK National Health Service (NHS) to help detect cancer early by making the Galleri test available to eligible UK patients through the NHS-Galleri trial. Learn more about the NHS-Galleri trial in the U.K at NHS-Galleri.org.
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About MedTech Breakthrough
Part of Tech Breakthrough, a leading market intelligence and recognition platform for global technology innovation and leadership, the MedTech Breakthrough Awards program is devoted to honoring excellence in medical and health related technology companies, products, services and people. The MedTech Breakthrough Awards provide a platform for public recognition around the achievements of breakthrough health and medical companies and products in categories that include Patient Engagement, mHealth, Health & Fitness, Clinical Administration, Healthcare IoT, Medical Data, Healthcare Cybersecurity and more. For more information visit MedTechBreakthrough.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 cancer 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 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 may not detect a cancer signal across 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.