Health officials have approved a new blood test to screen for colon cancer.
The FDA announced Monday it signed off on Shield, a blood test from California-based Guardant Health.
While the test is not meant to replace colonoscopies – the gold standard for screening – doctors believe it could help combat the surge in colorectal cancer cases across the US, particularly in young people.
And the tool, which currently retails for almost $900, will likely be covered by most insurance plans, though it’s unclear when that coverage will start.
Guardant’s blood test, which currently retails for $895, is expected to be covered by most insurance plans following FDA approval
Dr Sapna Syngal, director of strategic planning for prevention and early cancer detection at the Dana-Farber Cancer Center in Boston, told NBC News: ‘The biggest problem with colon cancer right now is that there’s a significant part of the population that’s not getting screened.’
‘If this test increases the number of people getting screened, it’s going to have a huge impact.’
Guardant recommends Shield be given every three years, starting at age 45 – the same age recommended colonoscopies should begin.
If Shield detects cancerous DNA, a colonoscopy is still needed to locate tumors.
Dr Robert Smith, senior vice president of Early Cancer Detection Science at the American Cancer Society, told NBC News: ‘People have to understand that a positive Shield test requires a colonoscopy to confirm that you have an advanced lesion or colorectal cancer, or that the results were false.’
‘A test like this is not complete if it’s positive and you have not had a colonoscopy.’
The approval comes after a March study found that Shield was 83 percent effective in detecting colorectal cancer, though it is best suited for finding later-stage disease.
The study found that the test, which detects DNA released by cancerous tumors into the bloodstream, was only 13 percent effective in finding earlier stage disease.
Roughly one in four colorectal cancers are detected at stages three or four, and less than 20 percent of patients with stage four disease will survive after five years, according to the NCI.
The American Cancer Society estimates that more than 53,000 people will die from colon cancer this year, and that number has surged especially in Americans under 50.
Scientists are still figuring out what exactly is behind the increase, but recent research suggests that diets high in red meat, processed foods, and sugar could be to blame.
And researchers at the University of Florida are recruiting young patients to determine if energy drinks containing taurine could also fuel colorectal cancer.
Dr Arvind Dasari, an associate professor in the department of gastrointestinal and medical oncology at the University of Texas MD Anderson Cancer Center, told NBC News that the approval was a ‘welcome development,’ though he cautioned that the exact impact is still unclear.
‘We’ll have to wait and see what the impact will be in terms of improving screening and reducing the incidence of mortality.’
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