Blood test for colon cancer screening is approved by US regulators
U.S. health regulators have approved a blood test for colon cancer, offering a new way of screening for a leading cause of cancer deaths
WASHINGTON (AP) — U.S. health regulators on Monday approved a first-of-its-kind blood test for colon cancer, offering a new way of screening for a leading cause of cancer deaths.
Test manufacturer Guardant said the Food and Drug Administration approved its Shield test for screening in adults 45 and older who have an average risk of colon cancer. The test isn't a replacement for colonoscopies, but provides a noninvasive approach to screening.
Doctors can already order Shield for patients as a laboratory test with an out-of-pocket price of $895. But FDA approval is expected to increase coverage by private and government insurance.
The test looks for DNA fragments shed by tumor cells and precancerous growths. In a study published in March, the test caught 83% of the cancers but very few of the precancerous growths found by colonoscopy, the gold standard for colon cancer screening. The test missed 17% of cancers, performance that is on par with stool-based tests.
