Colorectal Cancer Screening Study Launched

Enrollment has begun in a study to determine the specificity and sensitivity of a stool-based DNA test for colorectal cancer, using colonoscopy as the reference method.

The test, called Cologuard, is a combination of two DNA methylation markers, seven DNA mutation markers, and a hemoglobin marker. It detects cancer throughout the entire area of the colon and patients are not required to undergo any special preparation before taking the test. The Cologuard test is likely to be recommended once every three years, compared to fecal occult blood test usually done yearly.

Exact Sciences (Madison, WI, USA) said that it plans to carry out the study at 60 sites in the US and Canada. It expects those sites will enroll more than 10,000 patients between the ages of 50 and 84 who are at average risk for developing colorectal cancer.

The latest American Cancer Society colorectal cancer screening guidelines include sDNA testing as a recommended screening option. The Exact CRC screening test, currently an investigational device, works by detecting specific altered DNA sequences in cells that are shed from the lining of the colon into the stool from precancerous or cancerous lesions. The test also includes a hemoglobin detection component, which identifies the presence of blood in the stool, another possible indicator of colorectal cancer.

The data generated from the trial will support Exact Sciences' planned Premarket Approval application for the Cologuard test. Kevin Conroy Exact Sciences president and CEO told investors at the Jefferies Global Healthcare Conference in June 2011 that the firm is planning a US Food and Drug Administration (FDA; Silver Spring, MD, USA) submission for the test in 2012

Related Links:
Exact Sciences
US Food and Drug Administration