FDA panel recommends approval of blood test to detect colon cancer

A panel at the Food and Drug Administration (FDA) on Thursday recommended the approval of a new blood test that could detect colon and rectum cancer.

Colon cancer is the second-leading cause of cancer fatalities in the United States and worldwide and is most commonly found in older adults, according to the World Health Organization. Colorectal cancer is the third most common form of cancer worldwide.

If approved, the new blood test would be the second blood test used to diagnose colorectal cancer. The first was approved in 2016, according to Reuters.

The panelists said colonoscopies are still the best way to diagnose colon cancers, but they are more invasive. Blood tests would be ideal but they are less accurate. The new blood pen, called Shield, only detected 83% of colon cancers. The older test has a 92% positivity rate.

Panelists also expressed concern over the new test only detecting 13% of pre-cancerous tumors, and said the tests should be repeated in 1-3 years. 

"[Shield] is better than nothing but I don’t want to downplay the issue that this test is going to miss a lot of cancers,” Charity Morgan, a panel member and professor in the department of biostatistics at University of Alabama, told Reuters.

The panel passed its recommendation in a 7-2 vote on the benefits of the test outweighing the risks. But 8-1 said it was safe for use in people who meet the criteria for the test, while 6-3 said it was effective in those cases, according to CNN.

The recommendation now goes to FDA officials, who take the referral into the consideration. But it does not have to approve the test.

Misty Severi is an evening news reporter for Just the News. You can follow her on X for more coverage.