Blood Test SHIELD for Colon Cancer Screening Gets Thumbs Up

Blood Test SHIELD for Colon Cancer Screening Gets Thumbs Up
Blood Test SHIELD for Colon Cancer Screening Gets Thumbs Up. Credit | Getty images

United States: Recently , an premonitory panel of the U.S. Food and Drug Administration suggested that a new blood test for colon cancer be approved. The panel decided, 7 – 2, that there were further advantages than disadvantages to espousing the Shield test from Guardant Health to diagnose colon cancer.

Advancing Cancer Screening

Co-CEO of Guardant, Amir Ali Talasaz, stated in a business news release reporting the panel vote, “The advisory committee’s strong support for the approval of Shield reinforces the crucial role that a blood test option can have in improving [colon cancer] screening rates for those at average risk.”

Improving Screening Rates

“There are significant obstacles that may discourage Americans at average risk from completing current screening protocols, even though early detection of colorectal cancer is crucial,” Talasaz continued. “Shield efficiently identifies cancer when it’s still highly curable, in its early stages. In addition to other non invasive stool tests, giving this blood test to individuals can raise the rate of colorectal screening and possibly lower the number of deaths from colon cancer that could have been prevented.

Historic Approval Pending

Should the FDA approve Shield, it will make history as the second blood-based test for colon cancer in the US; Epigenomics’ Epi pro Colon was authorized in 2016.

According to the American Cancer Society, colon cancer is the second most common cause of cancer-related deaths in the United States, accounting for over 50,000 deaths annually, with around 150,000 new cases being diagnosed with the disease.

Colon Cancer’s Impact

The gold standard test for colon cancer right now is a colonoscopy, but because it’s invasive and requires a lot of preparation, test adherence is poor. Other tests include fecal testing, such the Cologuard test from Exact Sciences, although blood-based tests are thought to be more practical, according to NBC News.

Concerns were voiced by the panel over Guardant’s test’s lack of accuracy in comparison to colonoscopy, particularly given that Shield only identified 13% of advanced adenomas, which are precancerous tumors, according to NBC News. FDA employees also brought up this concern in briefing documents.

According to FDA papers, Guardant’s application for approval was predicated on a research indicating the test identified 83% of colon cancer cases.

Debate Over Test Reliability

Panelist Charity Morgan, a professor in the University of Alabama’s department of biostatistics, stated during the conference that Shield “is better than nothing, but I don’t want to downplay the issue that this test is going to miss a lot of cancers.” NBC News reported.

Victoria Raymond, a representative of Guardant Health, stated during the conference that the business anticipates the test will need to be repeated every one to three years. However, she also stated that “colonoscopy should be the prioritized option,” as reported by NBC News.