Guardant Health's Shield Blood Test for Colorectal Cancer Screening Gets FDA Approval

Author: Benzinga Newsdesk | July 29, 2024 06:31am

Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company, today announced the U.S. Food and Drug Administration (FDA) has approved the company's Shield™ blood test for colorectal cancer (CRC) screening in adults age 45 and older who are at average risk for the disease. It is the first blood test to be approved by the FDA as a primary screening option for CRC, meaning healthcare providers can offer Shield in a manner similar to all other non-invasive methods recommended in screening guidelines. Shield is also the first blood test for CRC screening that meets the requirements for Medicare coverage.1

Shield is a blood test from Guardant Health for colorectal cancer screening in average-risk individuals 45 and older. (Photo: Business Wire)

Colorectal cancer is the second-leading cause of cancer-related death in the U.S., even though it is highly treatable if caught early.2 The American Cancer Society estimates that more than 150,000 people will be diagnosed with CRC in 2024 and the disease will be responsible for more than 53,000 deaths.3 More than three out of four individuals who die from CRC are not up to date with their screening.4 Early detection is critical. When colon cancer is found at an early stage before it has spread, the five-year relative survival rate is 91%. If the cancer has spread to distant parts of the body, the five-year relative survival rate is 14%.5

The CRC screening rate in the U.S. is only about 59%, which falls well below the National Colorectal Cancer Roundtable's goal of 80% for eligible individuals.6 More than one out of three eligible Americans – over 50 million people – do not complete CRC screening, often due to the perception that other available options, such as colonoscopy or stool-based tests, are invasive, unpleasant or inconvenient.7

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