FDA approves innovative, non-invasive colon cancer screenings

FDA approves innovative, non-invasive colon cancer screenings

Cologuard, a non-invasive colon cancer screening system that tests DNA in stool samples, will be provided by CMS to Medicare patients every three years.

For anyone who dreads their upcoming colonoscopy (and isn’t that everyone?), you don’t have to dread having one anymore. The U.S. Food and Drug Administration has given a revolutionary new DNA testing product its stamp of approval, and the Center for Medicare and Medicaid Services has agreed to provide it once every three years for Medicare patients.

The product is called Cologuard; the first test to use DNA for cancer screenings, it was developed by biotechnology firm Exact Sciences. It analyzes DNA in stool samples to test for precancerous changes in the double helix. As opposed to an uncomfortable colonoscopy, it’s a non-invasive procedure that simply requires patients to produce a sample at their doctors’ office.

Colon cancer is highly preventable through regular colonoscopy screenings, but many patients decline to have them done due to the discomfort of the preparation and the procedure. Because the colonoscopy is such a dreaded procedure, colorectal cancer can go undetected and metastasize into other parts of the body such as the brain, lungs, and lymph nodes.

The procedure is beneficial for patients in that it’s non-invasive, but it’s also been a boon for Exact Sciences. After CMS announced it would pay for Cologuard screenings, the company’s stock rocketed by over 40%.

Medicare currently serves over 50 million Americans, and Cologuard would be administered to each one every three years. While Cologuard may sound costly, it’s far less expensive than treatments for late-stage cancer or palliative care.

Colorectal cancer is a leading cause of cancer deaths, making up one-third of all global fatalities. It’s far more common in men than women, and is predominantly found in developed countries. Symptoms include fatigue, blood in the stool, and unexplained weight loss. Risk factors include age, gender, smoking status, and lack of physical activity. Genetics does not play a significant role in the development of colon cancer.

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