Colon Cancer: New Test Approved

Long time readers of this blog will recall that I am 1) a strong advocate for evidence-based health screenings (e.g., pap smears), 2) approaching the age of 50 -when certain health screenings should begin- and 3) holding out hope that something noninvasive will replace the colonoscopy.  The colonoscopy is currently the gold standard for detection of precancerous tissues (polyps) that form in the intestines or rectum and can lead to cancer (colorectal cancer).

This month, in an unprecedented move, Medicare approved coverage for a new test at the same time that the FDA approved its use.  The unprecedented part is that the approval and coverage occurred at the same time - which is the result of a new pilot parallel research program that I am not going to discuss here. My focus is the new colon cancer screening test, which is conducted on a persons stool (bowel movement).

The test, Cologuard, is different from currently approved and recommended fecal occult tests because it also tests the stool for DNA found in the cells of cancerous polyps (adenomas). The FDA press release explains how shedding cancerous cells can be collected by the stool as it passes through the body for elimination. 

Currently, the American Cancer Society, CDC and the US Preventive Task Force recommend three screening tests for colorectal cancer, but only one diagnostic test - the colonoscopy.  The three tests are the Fecal Occult Blood Test (FOBT), the flexible sigmoidoscopy and the colonoscopy.  The tests are repeated at different intervals, the least invasive one, the FOBT, is done yearly; the next least uncomfortable, the sigmoidoscopy, every five years; and the colonoscopy, which allows for the removal of polyps if they are found during the procedure, is currently recommended every ten years.  For most people, the screening should begin at age 50.

So far, the only insurance company to approve coverage of the new DNA test is Medicare and most people must be age 65 to receive Medicare; however; private insurance companies usually follow the same guidelines as Medicare - so I'd keep a watch on that.

You can see the screening recommendations here, but keep in mind, they have not been updated to included the Cologuard test - (yet?)