Guardant Health is dedicated to supporting patients with cancer across the continuum of care1
*The U.S. Food and Drug Administration (FDA) grants oversight of Lab Developed Tests (LDTs) to the Centers for Medicare and Medicaid Services (CMS). LDTs are regulated by CMS under the Clinical Laboratory Improvement Amendment (CLIA) which subjects LDTs to strict personnel, quality control, and proficiency testing standards.
Guardant Health is a leading precision oncology company that has been established for a decade with a mission to conquer cancer with data.
At Guardant Health we have now advanced our technology to include screening, for early Colorectal cancer (CRC) detection by applying a multi-modal approach to detect CRC signals in the bloodstream, including DNA that is shed by tumors.2,3,4
Colorectal cancer is the 2nd leading cause of cancer deaths among men and women6,14
Screening is the key to reducing Colorectal cancer (CRC) mortality. 60% of all CRC deaths can be prevented with regular screening12,13 – yet, 1 in 3 eligible patients remains unscreened.11
Early detection saves lives2
Screening matters for all patients
of people diagnosed with CRC in early stages survive6,11
of people diagnosed with CRC in late stages survive6,11
CRC screening compliance rates remain stagnant and low with current stool tests and colonoscopy20
Many factors can prevent patient follow-through for more conventional methods18,21-23
High compliance rate in real world clinical settings
Colorectal cancer (CRC) survivor shares his story
John Gormly, who went unscreened for 20 years for colon cancer, shares his personal story of how Shield, a simple blood-based screening test, helped identify cancer during a routine wellness visit.
John’s PCP and GI worked together, to bring a simple screening solution to catch his cancer at stage 2 and get him the right treatments to save his life.
- The assay is intended to be complementary to and not a replacement for current recommended colorectal cancer screening methods
- Patients with an “abnormal signal detected” Shield result should be referred for colonoscopic evaluation
- A “normal signal detected” Shield result does not preclude the presence of colorectal neoplasia, and patients should continue participating in guideline-recommended screening programs
- Shield was developed, and its performance characteristics determined, by the Guardant Health Clinical Laboratory in Redwood City, CA, USA, which is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high complexity clinical testing. This test has not been cleared or approved by the US FDA