Colorectal cancer (cancer of the colon or rectum) is the third most prevalent cancer in North America, after lung and breast cancer. It is the second most common cause of cancer death. Colorectal cancer affects men and women equally.

In 2006, the American Cancer Society projects there will be 148,610 new cases of colorectal cancer in the U.S. and more than 55,170 deaths (accounting for 10 percent of all cancer deaths). This relatively high mortality rate is due in part to the lack of accurate screening tests for the early detection of the disease. The primary risk factor for colorectal cancer is age, with more than 90% of cases diagnosed in individuals over the age of 50. 

Early-stage disease is not usually associated with symptoms. In about 60% of all cases, the disease has spread beyond the colon or rectum at the time of diagnosis. According to the American Cancer Society, only 39% of colorectal cancers identified are detected at an early, localized stage. When detected at that early stage the survival rate for patients is 90%.

Screening must identify early-stage disease in symptomatic individuals in order to be effective. The American Cancer Society recommends screening for colorectal cancer beginning at age 50, including:

• Yearly fecal occult blood test (FOBT);
• Flexible sigmoidoscopy every five years;
• Yearly FOBT plus flexible sigmoidoscopy every five years;
• Double contrast barium enema every five years; and
• Colonoscopy every 10 years.

The U.S. Census Bureau estimates that there are approximately 80 million Americans over the age of 50. It is estimated that fewer than half of the people who should be screened for this deadly disease actually are. According to the National Cancer Institute, in 2003, 33% of people aged 50 and older had had an FOBT within the past two years. In 2000, 39% of people aged 50 and older had ever received a colorectal endoscopy (sigmoidoscopy or colonoscopy).

ColorectAlert™ requires a sample of rectal mucus to be taken by a doctor during a digital (gloved finger) rectal exam. This sample can be taken during a routine doctor visit. The sample is smeared onto a proprietary membrane and sent to a laboratory.

At the laboratory, the sample is treated with the enzyme galactose oxidase, then stained with Schiff’s reagent, which produces a color change. The treated sample is read with a color reader (spectrophotometer) to quantify the color change and determine the numeric ColorectAlert™ value.