FDA Approves First Blood Test for Colorectal Cancer Screening as American Cancer Society Updates Guidelines
核心洞察
The FDA has approved Guardant Health's Shield blood test (搜索), the first blood-based screening test for colorectal cancer (搜索) detection, which identifies tumor DNA (搜索) circulating in the bloodstream.
The American Cancer Society has updated its colorectal cancer (搜索) screening guidelines for the first time to include blood-based testing as an option for patients who decline or cannot complete preferred screening methods.
With colorectal cancer (搜索) being the second-leading cause of cancer deaths in the U.S. and over 55,000 expected deaths in 2026, early detection through expanded screening options could significantly improve the 91% survival rate when caught early.
The FDA has approved the first blood test for colorectal cancer (搜索) screening, marking a significant advancement in early detection options for the second-leading cause of cancer deaths in the United States. Guardant Health's Shield blood test (搜索) can detect circulating tumor DNA (搜索) in the bloodstream, offering a new screening alternative for patients who may avoid traditional methods.
Revolutionary Blood-Based Detection Technology
The Shield test works by identifying tumor DNA (搜索) that cancer cells shed into the bloodstream. "What the shield test does is it picks up whatever the tumor is shedding if there is colorectal cancer (搜索) in the bloodstream," explained Dr. Sam Asgarian with Guardant Health, a Tulane Medical School graduate. "The signs and signals that are found in the blood were found by the FDA to be as effective as if someone got a colonoscopy or a different colorectal cancer screening test."
This approval comes as the American Cancer Society simultaneously updated its screening guidelines to include blood-based testing for the first time, expanding options beyond traditional colonoscopy and stool-based tests.
Updated Screening Guidelines Address Critical Gap
The American Cancer Society's updated recommendations now include blood-based screening tests taken at a doctor's office, though they are positioned as an alternative for patients who decline or cannot complete preferred screening methods. The blood test screens for tumor DNA (搜索) in the blood and is recommended only when patients are unable or unwilling to undergo colonoscopy or at-home stool tests.
"Colonoscopy still remains, you know, a test that's, that's where there's no test that's better, but there are folks that are unable or unwilling to undergo a colonoscopy," said Dr. William Dahut, Chief Scientific Officer at the American Cancer Society.
Addressing a Public Health Crisis
Colorectal cancer (搜索) represents a significant public health challenge, with more than 55,000 deaths expected in 2026. The disease affects different populations disproportionately, with Louisiana showing the third-highest colorectal cancer incidence rate nationally. In Louisiana alone, over 26% of individuals who could be getting screened are not currently being tested.
The screening gap is substantial nationwide, with about one in three adults who are eligible for screenings remaining untested. This gap has deadly consequences, as three-quarters of the expected 50,000 annual deaths will either detect the cancer too late or not get screened at all.
Clinical Impact and Survival Rates
Early detection dramatically improves patient outcomes. When colorectal cancer (搜索) is caught early, there is a 91% chance of survival. "Colorectal cancer is a deadly disease," Dr. Asgarian emphasized. "If it's caught early, there's a 91% chance of survival. You give yourself the best chance of success if you get screened."
Comprehensive Screening Recommendations
The updated guidelines maintain that average-risk adults should start screenings at age 45 through 75. For individuals with family history of colorectal cancer (搜索), screening should begin 10 years before the age at which the family member was first diagnosed.
The guidelines now recommend that those at average risk take two at-home stool tests every three years. One test looks for DNA mutations, hidden blood, and specific genes, proteins, and molecules that could indicate cancer in stool samples.
Patients who receive abnormal blood test results must follow up with a colonoscopy for definitive diagnosis and treatment planning.
Expanding Access to Life-Saving Screening
"We need to increase our emphasis on colorectal cancer (搜索) as a highly preventable disease as much as a treatable one," said Dr. Robert Smith, senior vice president of early cancer detection science at the American Cancer Society. "By offering more screening tools in our guideline update, more eligible adults will be able to participate in lifesaving colorectal cancer testing, helping to close the screening gap and catch more cancers at an earlier, treatable stage."
The American Cancer Society has developed an online calculator to help people assess their risk for colorectal cancer (搜索), supporting the expanded screening initiative during National Colorectal Cancer Awareness Month in March.