New Blood Test Approved by FDA for Colorectal Cancer Screening

Guardant Health has announced the US Food and Drug Administration (FDA) approval of Shield, the company’s blood-based colorectal cancer (CRC) screening test for patients at average risk of the disease.

Developed for patients aged 45 years and older, the test marks the first FDA approval of a primary screening option for CRC, and it is the first blood-based test for CRC eligible for Medicare coverage.

The approval is based on results of the ECLIPSE study, which examined the blood-based test in a cohort of 7861 eligible patients. The test demonstrated a sensitivity rate of 83% and 13% for CRC and advanced precancerous lesions, respectively, as well as a specificity rate of 90% for advanced neoplasia.

In May 2022, over 90% of patients in a real-world setting who were prescribed Shield completed the test. Meanwhile, previous research has shown that only 28% to 71% of patients who are prescribed other screening methods, such as colonoscopy or stool tests, actually take them.

CRC is highly treatable when caught early, and more than 3 of 4 individuals who die from CRC are not up to date with screening, pointing to the importance of early detection. The 5-year survival rate is 91% when the disease is detected early versus 14% in patients whose cancer has metastasized.

The Shield test is performed in-office through a blood draw, providing an easier option for patients over tests that may require special preparation. Daniel Chung, MD, author of the ECLIPSE study, remarked that “the persistent gap in [CRC] screening rates shows that the existing screening options do not appeal to millions of people … the FDA’s approval of the Shield blood test marks a tremendous leap forward, offering a compelling new solution to close this gap. This decision will help make screening tests more broadly accessible and propel blood-based testing and CRC screening into a new era. With increased screening rates and early cancer detection, many more lives can be saved.”

Shield is available via prescription through a physician or other health care professional. Commercial insurance coverage for the test will expand following anticipated future guideline inclusions by the American Cancer Society and US Preventive Services Task Force.