WASHINGTON (AP) — U.S. health officials on Monday approved the first blood test for colorectal cancer, marking a new way to screen for a leading cause of cancer death.
Test maker Guardant said the Food and Drug Administration has approved the Shield test as a screening test for adults over 45 who are at average risk for colorectal cancer. The test is not a replacement for colonoscopy but does offer a non-invasive approach to screening.
Doctors can already order the shield as a lab test for patients, for a copay of $895, but FDA approval is expected to expand coverage through private and government insurance.
The test looks for DNA fragments and precancerous growths released by tumor cells. A study published in March found that the test detected 83% of cancers but failed to detect nearly all precancerous growths found by colonoscopy, the gold standard for colorectal cancer screening. The test missed 17% of cancers, which is comparable to stool-based tests.
Colonoscopy not only detects tumors, but can also prevent disease by removing precancerous growths called polyps.
However, some people avoid the test because it would be a hassle to take time off work or because it requires taking strong laxatives the day before to prepare for a bowel movement. In the United States, screening is recommended for healthy adults ages 45 to 75 who are at average risk for colorectal cancer.
Guardant said in a statement that doctors can administer the Shield test with a simple blood draw, and that the company plans to launch the product in the “near future.”
Annual colorectal cancer screening rates in the United States are about 60 percent, far short of the 80 percent goal set by groups such as the American Cancer Society for eligible adults.
