A group of experts from the U.S. Food and Drug Administration suggested approving a new blood test for detecting colon and rectal cancer, even though there are concerns about how accurate the test is.
Guardant Health, a biotechnology company based in California, has submitted an application to the FDA for approval of its blood test called Shield. This test is designed to detect early signs of colorectal cancer.
The FDA advisory panel voted 8-1 to say that the test is safe for people who meet the criteria for testing. They also voted 6-3 to say that the test is effective and 7-2 to say that the benefits of the test are greater than the risks. Panellists expressed concerns that Shield is not as reliable as colonoscopy screening.
In a research involving almost 8,000 patients, Shield was able to identify 83% of colorectal cancer cases. The test found 88% of colorectal cancer cases in stages I, II, or III, and about 13% of adenomas, which are precancerous tumours. The FDA reported that Exact’s stool-based Cologuard test had a sensitivity rate of 92.3% compared to other tests.
Dr. Sean Spencer, one of the panellists, voted in favour of advancing Shield. He believes that testing should be used to detect colon cancer in people who do not show any symptoms. “According to Spencer, the labelling should clearly state that this test is not meant to detect adenomas and is not designed for prevention.”
Dr. William Brugge, a member of the panel, believes that the test is not effective, although he considers it to be safe.
“I am mainly worried that Shield is not a very effective screening test for colon cancer,” Brugge said. He also believes that there are other tests available that are better.
The FDA will consider the panel discussions and voting outcomes to determine whether or not to approve the test.
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If it is approved, Shield will become the second blood-based test for colon cancer in the United States. The first one, called Epi proColon, was approved in 2016 and is made by Epigenomics.
According to Dr. Craig Eagle, the chief medical officer at Guardant Health, this would be the first blood-based test for colorectal cancer that is eligible for Medicare reimbursement.
Colonoscopy is the most accurate test for colorectal cancer. It can find abnormal growths in the colon or rectum, which a blood test cannot do. Many people choose not to get screened because the process can be invasive.
Robert Smith, a senior vice president at the American Cancer Society, believes that blood-based tests like Guardant Health’s Shield can greatly decrease the number of advanced cancer cases, even if they may not detect as many cases.
“According to him, many people want a blood-based option that is more accurate in detecting early signs of both precursor lesions and cancers,” he said. “However, what is quite remarkable about colorectal cancer screening is that different people have different levels of readiness to undergo a particular test.” “You need to provide people with options.”
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According to Charity Morgan, a biostatistics professor at the University of Alabama, Birmingham, the test is a better option than having no test at all for patients who have no other options. However, it is not as good as having a colonoscopy.
Guardant claimed that their test is easy to use and can be used often, increasing the likelihood of detecting dangerous polyps, despite the test’s lower detection rate. Every year, approximately 150,000 Americans are diagnosed with colon and rectal cancers. Sadly, more than a third of these cases are expected to result in death.
According to Dr. Jamin Brahmbhatt, a urologist and robotic surgeon with Orlando Health, in a CNN opinion piece in March, only about 60% of people who are eligible for cancer screenings actually keep up with them.
Brahmbatt mentioned that the blood test for colorectal cancer could potentially be used more widely for screening if it gets approved by the U.S. Food and Drug Administration.