GRAIL, LLC (“GRAIL”) is committed to its website being designed, developed, and operated in substantial conformance with generally recognized and accepted guidelines and/or standards for website accessibility (the “Standards”). While these Standards may change and/or evolve over time, they are currently the World Wide Web Consortium’s Web Content Accessibility Guidelines 2.1 at Levels A and AA (“WCAG 2.1”).
Working with an accessibility consultant, GRAIL will implement over time relevant portions of web accessibility standards, intended to bring www.galleri.com into further conformance with section 508 of the U.S. Access Board standards. Our website will be tested on a periodic basis with assistive technology such as screen readers, and by users with disabilities who use these technologies.
We welcome your feedback on the accessibility of the GRAIL website. Please let us know if you encounter accessibility barriers or wish to make any reasonable accommodation request.
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.
GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists (CAP). The Galleri test was developed, and its performance characteristics were determined by GRAIL. The Galleri test has not been cleared or approved by the 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.