Cologuard, a DNA stool test from Exact Sciences Inc., may soon make colonoscopies a thing of the past for many people.

The Madison, WI-based company says its test will detect as many as 92 percent of colorectal cancers. A recently-concluded 10,000 patient, 90-center clinical trial, the DeeP-C study, was designed to determine the performance characteristics of the Cologuard test for colorectal cancer, and to compare its performance to that of the the fecal immunochemical test (FIT), a commonly used alternative to colonoscopy.

The results are in, and the Cologuard test came out resoundingly on top versus the FIT test. In the study, the sensitivity of Cologuard in detecting patients with colorectal cancer was 92%, versus 74% for FIT. Further, Cologuard's sensitivity in detecting patients with colorectal cancers in Stages I-III, those determined by the American Joint Committee on Cancer to have the best chance of being cured, was 93 percent, versus 73 percent for FIT.

The peer-reviewed study, "Multi-target Stool DNA Testing for Colorectal-Cancer Screening," has been published online in the New England Journal of Medicine, and will appear in that journal's April 3 printed edition.

The study's lead author was Thomas F. Imperiale, MD, of the Indiana University School of Medicine, Regenstrief Institute Inc., the IU Simon Cancer Center, and the Roudebush VA Medical Center in Indianapolis. "We know that colorectal cancer can be prevented and can be highly treatable if found early through screening," Imperiale said in a news release. "Sensitivity is the most important characteristic for screening tests because the primary role of such testing is to rule out diseases such as cancer."

Imperiale explained that, "In our clinical study, the data show that Cologuard ... is highly sensitive in detecting colorectal cancer and higher-risk pre-cancerous polyps in a large, diverse, average-risk patient population and has the potential to be an important screening tool."

Colorectal cancer is considered one of the most preventable, yet least prevented, of cancers. The current recommendation for adults aged 50 and older is at least one screening every 10 years. Yet, Exact Sciences says, one out of three has not been screened as recommended. As a result, colorectal cancer remains the second-leading cancer killer in the United States. Colorectal cancer is highly treatable if found early, making the detection of pre-cancerous polyps paramount.

It should be noted that Exact Sciences' Cologuard screening test is an investigational device currently under review by FDA and is not available for sale in the United States. Exact Sciences says that FDA's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is scheduled to review the company's PMA application for Cologuard on March 27.

Stephen Levy is a contributor to Qmed and MPMN.