Good news for anyone concerned about colorectal cancer. The FDA has approved a new blood test to help pick up the disease in its early stages.
According to the makers of the blood test—California-based Guardant Health—it’s the first such blood test to be approved by the FDA for those at risk over the age of 45. The test, called “Shield,” also meets the requirements for Medicare reimbursement.
Gay men and cancer
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Men are more prone to experience certain cancers. These include prostate, lung, colorectal, and skin cancers.
Gay men specifically experience a heightened risk for several reasons. These include the fact we tend to smoke and drink more than our straight peers. Some are also more wary of visiting their doctor as they fear discrimination.
An increased likelihood of anal warts, caused by the HPV virus, can also increase the chances of gay men developing anal cancer later in life. Being HIV-positive has also been associated with some cancers.
Colorectal cancer can affect the rectum and parts of the bowel further up. It is the second most common cause of cancer deaths in the US. Around 150,000 people are diagnosed with the disease each year. Around one third of that number die from it.
Symptoms include diarrhoea, constipation, blood in the stool, abdominal pain, unexplained weight loss, fatigue, and low iron levels. However, there may be no symptoms in the early stages.
Until now, to investigate the possibility of colorectal cancer, people need to submit a stool sample or undergo a colonoscopy. A blood test is a welcome addition to the toolkit. If the cancer is detected before it spreads, the five-year survival rate is around 91%.
Protection for millions more people
“The persistent gap in colorectal cancer screening rates shows that the existing screening options do not appeal to millions of people,” said Daniel Chung, MD, gastroenterologist at Massachusetts General Hospital and Professor of Medicine at Harvard Medical School in a press release from Guardant Health on Monday .
“The FDA’s approval of the Shield blood test marks a tremendous leap forward, offering a compelling new solution to close this gap. This decision will help make screening tests more broadly accessible and propel blood-based testing and CRC screening into a new era. With increased screening rates and early cancer detection, many more lives can be saved.”
The FDA approval comes following a clinical trial that included 20,000 participants across 200 sites across the US.
“Shield demonstrated 83% sensitivity for the detection of CRC, with 90% specificity for advanced neoplasia [tumors],” said the press release. “This performance is within range of current guideline-recommended non-invasive screening methods, in which overall CRC sensitivity ranges from 74% to 92%.”
Following news of the FDA approval, Guardant Health announced its Shield blood test is now commercially available, as of today.
“The commercial launch of the Shield test and Medicare coverage make it possible for millions of eligible individuals to access a convenient, more pleasant way to stay up to date with colorectal cancer screening and detect the disease early, when it is more easily treated,” said AmirAli Talasaz, Guardant Health co-CEO.
“From day one, Shield will be covered for more than 45 million Medicare beneficiaries, including many who are non-compliant with colonoscopy.”
Related*
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War On Free Speech
I had my colonoscopy last year; clean as a whistle. Great news for medical advancement.