FDA panel nods to blood test for colon cancer

An advisory panel to the U.S. Food and Drug Administration on Thursday recommended approval of a new blood test that can detect colon cancer.

The panel voted 7-2 that the benefits outweighed the risks of using Guardant Health’s Shield test for colon cancer.

“The Advisory Committee’s strong support for Shield’s approval reinforces the critical role a blood testing option can play in improving [colon cancer] screening rates for people at average risk,” AmirAli Talasaz, co-CEO of Guardant, said in a company press release announcing the vote in the panel.

“Despite the importance of detecting colorectal cancer early, there are notable barriers that may prevent average-risk Americans from completing existing screening methods,” Talasaz added. “Shield effectively detects cancer at an early stage, when it is most treatable. Allowing people to undergo this blood test in addition to other non-invasive stool tests could increase the number of colorectal screenings and potentially reduce preventable risks. [colon cancer] deaths.”

If approved by the FDA, Shield would become the second blood-based colon cancer test in the United States: Epigenomics’ Epi proColon became approved in 2016.

Approximately 150,000 American patients are diagnosed with colon cancer each year, and according to the American Cancer Society, colon cancer is the second leading cause of cancer deaths in the country, with more than 50,000 deaths each year.

Currently, colonoscopy is the gold standard test for colon cancer, but compliance is low because it is invasive and preparation for the test is daunting. Other tests include fecal tests such as Exact Sciences’ Cologuard, but blood-based tests are considered more convenient, NBC News reported.

Panelists expressed concern that Guardant’s test was not as accurate as colonoscopy, especially because Shield detected only 13% of precancerous lesions called advanced adenomas, NBC News reported. This issue was also raised by FDA staff briefing papers.

Guardant’s approval application was based on a study that showed the test detected 83% of colon cancers, according to FDA documents.

Shield “is better than nothing, but I don’t want to minimize the issue that this test will miss a lot of cancer cases,” panelist Charity Morgan, a professor in the department of biostatistics at the University of Alabama, said at the meeting. panel meeting, NBC News reported.

The company expects the test will need to be repeated every one to three years, Victoria Raymond, director of Guardant Health, said at the meeting, but added that “colonoscopy should be the priority option,” NBC News reported.

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