Thomas Imperiale MD
Thomas F. Imperiale, MD

Exact Sciences Corp, Madison, Wis, reports that preliminary analysis shows that the company’s Cologuard colorectal cancer screening test met or exceeded all primary and secondary endpoints of its recently completed DeeP-C pivotal clinical trial.

The clinical trial evaluated the test’s use for the detection of colorectal cancer and precancerous polyps.

Preliminary, top-line data show that Cologuard demonstrated 92% sensitivity for the detection of colorectal cancer and 42% sensitivity for the detection of precancerous polyps, including 66% sensitivity for polyps equal to or greater than 2 centimeters. The test achieved a specificity of 87% during the trial.

According to the Journal of the National Cancer Institute, colorectal cancer is often considered the most preventable, yet least prevented cancer. But nearly 50% of those age 50 and older have not been screened as recommended. As a result, colorectal cancer is the second leading cause of cancer death in the United States.

The company’s pivotal DeeP-C trial included 10,000 patients between the ages of 50 and 84 who were at average risk for colorectal cancer. Enrollment was conducted at 90 sites to gain a broad demographic sampling of patients. The study is one of the most extensive colorectal cancer screening studies ever conducted in the United States. It compared the performance of the Cologuard test to colonoscopy and fecal immunochemical testing or FIT.

“The DeeP-C trial evaluated Cologuard’s ability to detect both precancerous polyps and cancer in a large, average-risk patient population,” says principal study investigator Thomas F. Imperiale, MD, professor of medicine, associate director for research for the division of gastroenterology at Indiana University School of Medicine and a member of the IU Simon Cancer Center. “There is a significant unmet clinical need for an accurate, convenient, noninvasive colorectal cancer screening test. The data from the DeeP-C trial are very promising. Cologuard may well be a future solution for identifying slow-growing polyps much before they develop into cancer.”

“We believe our test could become a great tool in the fight against this terrible disease,” says Kevin T. Conroy, president and chief executive of Exact Sciences.

Exact Sciences will submit data from the DeeP-C study to the FDA as part of its premarket approval (PMA) submission. Later this year, the company also will submit the study’s complete data set for publication in a peer-reviewed journal, presentation at a major medical meeting, or both.

The co-primary endpoints for the Deep-C study were the sensitivity and specificity of the Cologuard screening test for colorectal adenocarcinoma. The trial included two sets of co-secondary endpoints. The first included sensitivity and specificity of the test for advanced adenomas. The second included non-inferiority of Cologuard to FIT for cancer sensitivity and superiority to FIT for advanced adenoma sensitivity.

The Cologuard screening test is designed to detect specific changes in a patient’s DNA that appear in the stool and often indicate the presence of colorectal cancer or the precancerous polyps most likely to develop into it. The test also identifies the presence of blood in the stool, another indicator of possible colorectal cancer. The latest American Cancer Society colorectal cancer screening guidelines include stool-based DNA testing as a recommended screening option.

Each patient result from the Cologuard test was compared to the patient’s colonoscopy result and the histopathologic diagnosis of any lesions that were discovered during colonoscopy and biopsied. The study population included 64 cancer patients and 752 patients with precancerous polyps.

The Exact Sciences’ screening test is an investigational device and is not available for sale in the United States. The scientific information discussed here is preliminary and investigative, pending additional analysis by the company and review by the FDA.

[Source: Exact Sciences Corp]