U.S. health regulators approved a first-of-its-kind blood test for colon cancer screening, giving doctors a noninvasive screening option for average-risk adults starting at age 45, the Associated Press reported Monday.
In a statement, test manufacturer Guardant said the Food and Drug Administration approved its Shield blood test for screening adults 45 and older who have an average risk of colon cancer. Guardant described the test as a noninvasive alternative to colonoscopies but not a replacement for them.
Guardant said the Shield test works by looking for DNA fragments shed by tumor cells and precancerous growths. The company also said the test caught cancers in a study published in March, with results that AP said were on par with stool-based tests for overall cancer detection.
AP reported that the study found Shield caught 83% of cancers, while it missed 17% of cancers. The study also found that the blood test detected very few precancerous growths compared with colonoscopy, which is described as the gold standard for colon cancer screening.
The approval comes as colonoscopy-based screening remains difficult for many people, AP reported. It noted that some adults avoid the exam because of work and the day-ahead preparation, including drinking a strong laxative to empty the bowels. In the U.S., screening is recommended for healthy adults ages 45 to 75 at average risk for colon cancer.
AP said colonoscopies can both detect and prevent disease by removing precancerous growths called polyps. By contrast, Guardant said Shield can be run after a simple blood draw, and the company plans to launch the product “in the near future.”
Guardant said clinicians can already order Shield as a laboratory test, AP reported, at an out-of-pocket price of $895. The company said FDA approval is expected to increase coverage by private and government insurance, as participation in colon cancer screening remains below national targets.
AP reported that the annual rate of U.S. colon cancer screening is nearly 60%, well short of the 80% goal for age-eligible adults set by the American Cancer Society and other groups.