First Blood Test for Colorectal Cancer Shows Positive Results
Guardant Health’s investigational blood test to detect colorectal cancer in average-risk adults showed promising results in a 20,000-participant study evaluating what would be the first blood test available in the U.S. to scan for colorectal cancer.
Colorectal cancer is currently detected through a colonoscopy or DNA stool test.
The test demonstrated 83 percent sensitivity in detecting those who have colorectal cancer and 90 percent specificity for advanced neoplasia or patients who are negative for colon cancer.
Patients were also highly likely to complete the test after a routine visit with their physician. Among the first 8,000 participants, 90 percent completed the test. By contrast, the test completion rate for those who were assigned non-invasive stool tests ranged from 43 to 66 percent.
Based on the positive results, Guardant Health plans on completing its premarket approval submission to the FDA in the first quarter of 2023.