FDA approves blood test for colon cancer
(Gray News) - The Food and Drug Administration approved its first blood test as a primary screening tool for colon cancer, Guardant Health announced on Monday.
Shield is approved as a screening method for those 45 and older who are at average risk for colon cancer, the second-leading cause of cancer-related death in the U.S.
Shield also meets the requirements for Medicare coverage, the company announced.
The FDA decision follows its advisory committee’s approval recommendation in May.
According to a study, published in The New England Journal of Medicine, Shield demonstrated 83% sensitivity for the detection of colorectal cancer, with 90% specificity for advanced neoplasia.
AmirAli Talasaz, Guardant Health co-CEO, said the test will be launched in the near future.
“The FDA approval of the Shield test is a significant victory for patients and an important milestone in Guardant Health’s mission to conquer cancer with data. Shield can help improve colorectal cancer screening rates so we can detect more cancers at an early stage, when they are treatable,” he said.
Colon cancer, if caught early, is highly survivable, with a five-year relative survival rate is 91%, according to the American Cancer Society.
Overall, the lifetime risk of developing colorectal cancer is about 1 in 23 for men and 1 in 25 for women, with risks varying between individuals based on their overall risk factors for the disease.
Guardiant said it is thought that, with FDA approval, the test will soon be eligible for private health insurance coverage.
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