July 29, 2024
Provided Image/Guardant Health
Guardant Health's Shield blood test for colorectal cancer has been approved by the U.S. Food and Drug Administration, offering people an alternative to colonoscopies and stool tests.
For the first time, the U.S. Food and Drug Administration has approved a blood test as a primary screening option for colorectal cancer.
Guardant Health's Shield blood test was approved Monday as a screening option for adults 45 and older who are at average risk for the disease. The test, which will be available within one week, involves a blood draw that can be completed during a routine doctor's visit. That differs from other screening methods that may require special preparation, dietary changes, time and discomfort.
Screening options for colorectal cancer range from getting a stool test every 1-3 years to undergoing a colonoscopy once every 10 years. That procedure, which requires anesthesia, inspects the entire colon and rectum for polyps and signs of cancer.
Though the blood test may present a more pleasant screening option than fecal tests or colonoscopies, it has a poorer record of finding precancerous growths — which can be removed to prevent cancer, the New York Times reported. People who choose the blood test may still need to get colonoscopies if their tests indicate they may have cancer.
But more than 90% of patients who were prescribed the Shield test since May 2022 completed the blood test, according to Guardant. That is far higher than the 28% to 71% of patients who complete other prescribed screenings, including colonoscopies and stool tests. And in a study published in March, Guardant reported that its Shield test found 87% of cancers that were at an early and curable stage.
"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 in a press release from Guardant. "The FDA's approval of the Shield blood test marks a tremendous leap forward, offering a compelling new solution to close this gap.
"This decision will help make screening tests more broadly accessible and propel blood-based testing and (colorectal cancer) screening into a new era. With increased screening rates and early cancer detection, many more lives can be saved."
The Shield test is expected to be covered by Medicare.
Colorectal cancer, which forms in the colon or the rectum, is the leading cause of cancer death among men younger than 50. It's the second-leading cause among women in the same age range, behind breast cancer. The overall rate of colorectal cancer has been declining, but it has been rising among people 55 and younger by 1% to 2% each year since the mid-1990s. With this in mind, the U.S. Preventive Services Task Force dropped its recommended age for starting colorectal cancer screening from 50 to 45 for most adults.
If colorectal cancer is detected at an early stage before spreading, the five-year relative survival rate for colorectal cancer is about 90%, according to the American Cancer Society. Treatment may involve surgery, chemotherapy or radiation – or a combination of them.
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