NEW YORK (GenomeWeb News) – Exact Sciences today said that it has begun enrollment in a pivotal study of its multi-marker, molecular colorectal cancer screening test.
The Madison, Wis.-based firm 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 primary objective of the study is to determine the specificity and sensitivity of the firm's stool-based DNA test for colorectal cancer, using colonoscopy as the reference method. The test is a combination of two DNA methylation markers, seven DNA mutation markers, and a hemoglobin marker.
The data generated from the trial will support Exact Sciences' planned Premarket Approval application for the Cologuard test.
Exact Sciences President and CEO Kevin Conroy told investors at the Jefferies Global Healthcare Conference last month that the firm is planning a US Food and Drug Administration submission for the test in 2012.