FDA Panel Endorses Stool-Based DNA Colon Cancer Test

Key Points

  • An FDA panel has unanimously determined that Cologuard, a noninvasive, stool-based DNA screening test for colorectal cancer, has demonstrated safety, effectiveness, and a favorable risk-benefit profile.
  • Results of clinical trial show that Cologuard had a significantly higher sensitivity for detecting colorectal cancer compared with fecal immunochemical testing.
  • Cologuard is used to analyze stool samples for the presence of DNA methylation and mutation markers, total DNA, and hemoglobin.

The U.S. Food and Drug Administration’s (FDA) committee of genetic experts has determined that Cologuard, a stool-based DNA, noninvasive screening test for colorectal cancer, has demonstrated safety, effectiveness, and a favorable risk-benefit profile. The FDA is now considering the panel’s recommendation for approval of the test. The announcement was released by Cologuard’s manufacturer, Exact Sciences.

The FDA’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee voted 10–0 to approve Cologuard after reviewing the results the DeeP-C clinical study, published in The New England Journal of Medicine. The trial involved 10,000 patients between the ages of 50 and 84 enrolled at 90 centers in the United States and Canada who were considered to be at average risk for colorectal cancer and who were scheduled to undergo a colonoscopy screening.

The study was designed to determine the performance characteristics of the stool DNA test for colorectal cancer and to compare that performance to the fecal immunochemical test.

Study Findings

The study identified colorectal cancer in 65 of the patients screened. Of these participants, 60 had screening-relevant (stage I–III) cancer. A total of 757 participants who could be evaluated had advanced precancerous lesions.

The study results showed that Cologuard had a 92.3% sensitivity for all 65 malignancies vs 74% for fecal immunochemical testing and 93.3% sensitivity in detecting the stage I–III colorectal cancers, vs 73% for fecal immunochemical testing. In addition, sensitivity for patients with advanced precancerous lesions was 42% for Cologuard vs 24% for fecal immunochemical testing. The DNA test detected 69% of patients with polyps with high-grade dysplasia vs 46% for fecal immunochemical testing. Specificities for Cologuard vs fecal immunochemical testing were 87% vs 95%.

About Cologuard

Unlike conventional stool tests that identify evidence of occult bleeding, the Cologuard test is used to analyze stool samples for the presence of DNA methylation and mutation markers, total DNA, and hemoglobin. The test is designed to have patients collect a stool sample at home and send it to a lab for DNA analysis. Physicians would then discuss the results with their patients and refer patients with positive results for a diagnostic colonoscopy.

“We are pleased the Committee strongly supported Cologuard’s approval. We look forward to continuing our work with the FDA to complete its review of Cologuard and remain committed to addressing the growing unmet needs in colorectal cancer screening,” Kevin T. Conroy, Chairman and Chief Executive of Exact Sciences said in a statement.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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