Precision oncology company Guardant Health today announced positive results from a study demonstrating the effectiveness of its blood-based test for colorectal cancer, Shield. In a news release, the company said the test showed 83% sensitivity for the detection of colorectal cancer with a specificity of 90%.
With these results, Guardant Health can complete its premarket approval submission to the U.S. Food and Drug Administration. The FDA will conduct an in-depth review, and Shield could then become the first FDA-approved blood test for colorectal cancer. The test already exceeds the performance criteria for Medicare reimbursement.
“This a step toward providing people with an incredibly convenient and simple way to get checked for colorectal cancer,” said Michael Sapienza, CEO of the Colorectal Cancer Alliance. “Colorectal cancer screening is the No. 1 way to prevent this disease, and we look forward to working with Guardant Health to get more people checked.”
In May, Guardant Health announced the limited availability of Shield through a prescription. That announcement came after a clinical trial of 309 patient samples showed a 91% sensitivity. The latest study, called ECLIPSE, monitored more than 20,000 average-risk adults.
The Colorectal Cancer Alliance aligns with screening methods evaluated and approved by the United States Preventive Services Task Force (USPSTF). The task force has not recommended Guardant Health’s test. The Alliance will provide updates on the approval processes at the FDA and the USPSTF and, for now, recommends current USPSTF-approved screening methods.
With more than 49 million eligible people in the U.S. remaining unscreened for colorectal cancer, a screening test that uses a simple blood draw could inspire more people to get checked for the second deadliest cancer in the country.
“We are confident that a high-sensitivity blood test can play a critical role in improving screening adherence rates by offering an accurate and convenient blood test to those reluctant to get screened,” said AmirAli Talasaz, Guardant Health co-CEO, in the release.
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