COLOSURE™ (STOOL DNA TESTING)

What ColoSure™ Screening Tells You

There are several different colon and rectal cancer screening tests. The purpose of all of these screening tests is to try to catch cancer in its earliest stages — before it has grown large or spread to other parts of the body. There is a greater chance that a cancer can be stopped when it is caught during these stages, than when cancer is diagnosed after symptoms have begun to appear. As a result, screening for colon cancer has been definitively shown to reduce deaths from this disease.

Screening Procedures
Screening Guidelines
How Accurate Is ColoSure™?

Screening Procedures

Doctors can detect cancer and in some cases, pre-cancerous polyps, in different ways:

  • by looking directly inside your colon (colonoscopy or sigmoidoscopy)
  • by X-ray visualization (double-contrast barium enema, or DCBE)
  • by testing your stool for blood that may indicate the presence of a bleeding polyp (fecal occult blood testing or FOBT, fecal immunochemical test or FIT)
  • by testing your stool for immunochemical markers that may indicte cancerous growths
  • by testing your stool for a DNA marker that signal cancerous growths (ColoSure™)

Compare screening options.

Screening Guidelines

Currently, the American Cancer Society and many medical associations recommend that people age 50 and over who are at average risk for colon cancer follow one of these screening routines:

  • Colonoscopy every 10 years
  • Double contrast barium enema every 5 years
  • Flexible sigmoidoscopy every 5 years
  • Computed tomography colonography (virtual colonoscopy) every 5 years
  • Fecal occult blood test (FOBT) or fecal immunochemical test (FIT) every year. Note: a take-home, multi-sample kit should be used. A single FOBT test done in the physician's office after a digital rectal exam is not recommended.
  • Stool DNA test (ColoSure™ is a stool DNA test), uncertain how often how to repeat this test

How Accurate Is ColoSure™?

In patients who have invasive colon cancer, ColoSure was able to detect 3 out of 4 (72–77%) of those cases. This means that ColoSure was positive in up to 77 out of 100 people who had colon cancer. It was negative in up to 23 people who had colon cancer. ColoSure’s detection rate in the general population screening has not yet been determined. It is still being researched.

In people who did not have colon cancer, ColoSure was negative in 86 out of 100 people (86%). This means that 14 out of 100 people had a positive ColoSure but did not have colon cancer. The average age of the people in these studies was 58. The number of people who had a positive ColoSure but did not have colon cancer was slightly higher for people who were in an older age group (average age 65). In that group, 18 out of 100 people who did not have colon cancer had a positive ColoSure test.

Colonoscopy, which is an invasive procedure, is the gold standard for colorectal cancer screening.

 

Reviewed By:

  • Jennifer Graham MS, CGC
  • Katherine A. Rauen MD, Ph.D

Authored By:

  • null DNA Direct null

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