FDA approves blood test for colorectal cancer
Add Axios as your preferred source to
see more of our stories on Google.
Illustration: Eniola Odetunde/Axios
The Food and Drug Administration on Monday approved a blood test to detect colorectal cancer in individuals age 45 and older, adding another screening option for the second-most common cause of U.S. cancer deaths.
Why it matters: More than 1 out of 3 eligible Americans don't complete screening methods such as colonoscopy or a stool test, and a simple blood draw for the condition could be incorporated into routine physicals.
Yes, but: The Shield test from Guardant has limited detection of early stage colorectal cancer and does not detect 87% of precancerous growths. It's not viewed as a replacement for a diagnostic colonoscopy.
State of play: Shield is expected to launch within the next week — and the FDA approval makes it the first blood test for colorectal cancer for people at average risk that meets requirements for Medicare coverage.
- The company hasn't announced a list price but said it expects commercial insurance coverage will expand as the test is endorsed by the American Cancer Society and the U.S. Preventive Services Task Force.
- "This is a promising step toward making more convenient tools available to detect colorectal cancer early while it is more easily treated," said William Grady, a gastroenterologist at Fred Hutchinson Cancer Center who was involved in clinical trials of the blood test.
How it works: The test screens for DNA that tumors shed in the bloodstream.
- It was shown in a clinical trial to have an 83.1% sensitivity rate for colorectal cancer, and correctly identified 89.9% of patients without colorectal cancer or precancerous lesions.
- A positive result raises enough concern about the presence of cancer to warrant a colonoscopy evaluation, the company said.
An FDA advisory panel in May recommended the blood test as a convenient, non-invasive screening option, though some members expressed concern about false negative tests that miss precancerous lesions.
The big picture: New cases of colon cancer have been declining among adults 65 and older, but they've increased 1% to 2% annually in people younger than 55 since the mid-1990s, according to the American Cancer Society.
- People are not only getting diagnosed younger but are being diagnosed with more advanced cases of the disease, underscoring the need to be screened earlier.
