Blitz Bureau
The U.S. Food and Drug Administration (FDA) has approved a new blood test for colorectal cancer (CRC) screening for adults ages 45 and older who are at average risk for the disease, according to a statement from Guardant Health Inc. The FDA’s decision follows a strong recommendation for approval from an advisory committee panel in May 2024.
The approval of Guardant Health’s “Shield” test marks the first time that a blood test has been recognized by the FDA as a primary screening option for CRC, offering a noninvasive alternative to traditional methods such as colonoscopies and stool-based tests.
Colorectal cancer is the secondleading cause of cancer-related deaths in the United States, with the American Cancer Society estimating more than 150,000 new diagnoses and 53,000 deaths in 2024 alone.
Gap in screening rates
The screening rate for CRC in the United States stands at about 59 per cent, significantly below the National Colorectal Cancer Roundtable’s goal of at least 80 per cent. Many people avoid traditional screening methods because of their invasive and unpleasant nature, according to the statement.
“The persistent gap in colorectal cancer screening rates shows that the existing screening options do not appeal to millions of people,” Dr. Daniel Chung, a gastroenterologist at Massachusetts General Hospital and professor of medicine at Harvard Medical School, said.
A major clinical trial, the ECLIPSE study, demonstrated that the Shield test has an 83 per cent sensitivity for detecting CRC and a 90 per cent specificity for advanced neoplasia, according to the company. The advisory committee panel acknowledged the test’s reliability for detecting stages 2, 3, and 4 CRC and emphasised the benefit of having a blood test that can achieve higher adherence rates among patients who avoid colonoscopies or stool-based tests, according to a report by The Epoch Times.
A word of caution
However, it stressed that Guardant Health must make sure that consumers are aware that the blood test is not equivalent to a colonoscopy in its ability to detect and remove benign polyps before they can become cancerous.
