Food and Drug Administration approved Monday Protect your health”A blood test called Shield, used to screen for colon cancer. The test is not intended to replace colonoscopies, but it has sparked enthusiasm among doctors who say it has the potential to improve sluggish rates of colonoscopies. The second leading cause of death from cancer In the U.S.
Shield was previously available to doctors as a screening tool at a co-pay cost of $895. With FDA approval, Medicare and private insurance companies are more likely to cover the cost of blood testing, making it more accessible to patients.
Dr. Arvind Dasari, associate professor of gastrointestinal and medical oncology at The University of Texas MD Anderson Cancer Center, called the approval “welcome development.”
But, he warned, “we have to wait and see what impact this has on improving screening and reducing mortality.”
The American Cancer Society estimates that more than 53,000 people will die colorectal cancer this year.
Research An article published in March showed that Shield was 83% effective in detecting colorectal cancer. It works by detecting DNA released into the blood by cancerous tumors.
It is most effective at finding late-stage cancers when tumors release more DNA. Studies found that Shield only detected 13 percent of early-stage polyps.
The test needs to be done at least every three years, starting at age 45 – the same age today It is recommended to start colorectal screening.
A positive test is not necessarily a diagnosis. If the results indicate the presence of cancer, the patient will still need a colonoscopy so doctors can see where the tumors are and how advanced they are.
“People have to understand that a positive Shield test requires a colonoscopy to confirm that you have advanced disease or colorectal cancer, otherwise the results are wrong,” said Robert Smith, senior vice president of science for early cancer detection at the American Cancer Society. “A test like this is incomplete if the result is positive and you haven’t had a colonoscopy.”
This is the second blood test to screen for colon cancer; Epigenomics’ Epi proColon was approved in 2016. It is also not covered by Medicare or private insurance.
Since the mid-1990s, there has been an alarming upward trend in colon cancer rates among people under 55 years of age, with rates in this age group increasing by 1% to 2% per year. Meanwhile, cases and deaths among adults 60 and older have been declining, according to the World Health Organization. American Cancer Society.
“What breaks my heart is that this is preventable,” said Dr. William Grady, a gastroenterologist at Fred Hutchinson Cancer Center in Seattle. “One of my greatest joys is when I have a colonoscopy and I get to remove a polyp,” which can develop into cancer if left alone.
In fact, colorectal cancer is one of the only cancers that can be prevented through screening, and colonoscopy is by far the most accurate test. But screening rates are extremely low. Below 60% Eligible individuals have undergone recommended screening.
“The biggest problem with colon cancer right now is that a large proportion of people are not being screened,” said Dr. Sapna Syngal, director of prevention and early cancer detection strategic planning at Dana-Farber Cancer Center in Boston. “If this test increases the number of people who are screened, The number of people, that will have a huge impact.”
Grady, who led the Shield testing study in March, said it was typically adults in their 40s and 50s who were least likely to comply with screening.
“These are working people, many have families, so you have all the other life responsibilities that get in the way of taking care of yourself,” he said.
Colonoscopies are very time-consuming, forcing people to take at least a day off. There’s also a “yuck” factor that makes many people uncomfortable. During the surgery, doctors insert a tiny camera into the rectum to look for tumors or spots that may become cancerous in the future.
The camera needs to have a clear view of the colon. The day before the colonoscopy, the patient must take a high dose of laxatives. That is, they spend a lot of time in the bathroom.
“A lot of people don’t like the mess of dealing with stool, and a lot of people really don’t like colonoscopies — mostly,” said Electra Paskett, associate director of population sciences and community outreach at The Ohio State University Comprehensive Cancer Center. It’s preparation. “I think a blood test would be ideal for a lot of people. “
Another colorectal cancer screening method includes fecal occult blood test That Test blood Found in stool, this may be a warning sign of colon polyps or cancer. FIT-DNA tests (such as Cologuard) are very effective at detecting cancer, but less effective at detecting precancerous polyps.
John Gormly, 77, of Newport Beach, California, had avoided colonoscopies for years. When his doctor gave him the option of having a SHIELD blood test, he took it.
“About a day later, he called me and said, ‘I don’t like the results. I’m going to send you for a colonoscopy,'” Gormley recalled. “Turns out I had stage II colon cancer.” Surgeons were able to completely remove the tumor.
“Thank God I got the blood test,” Gormley said. “I never felt anything, never knew anything was wrong. Without the blood test, I don’t know what the results would have been.”
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