Date: 2011-08-03
Type of information:
phase:
Announcement: initiation
Company: MDX Health (Belgium) Exact Sciences (USA)
Product: colon cancer screening tests
Action mechanism:
Disease: colorectal advanced adenomatous polyps
Therapeutic area: Cancer Oncology
Country: USA, Canada
Trial details:
Latest
news: MDxHealth has announced that its licensing partner Exact Sciences Corp has initiated a large pivotal trial for Cologuard®, its non-invasive, stool-based DNA colon cancer screening test. Exact confirmed that it is using an MDxHealth methylation biomarker together with MDxHealth\'s methylation specific PCR (MSP) platform in Cologuard.
Exact\'s multi-center DeeP-C study (Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer) will generate data to support its planned PMA submission to the U.S. Food and Drug Administration (FDA) in 2012. The company began enrolling patients in the study on June 30, 2011. It is planning to qualify approximately 60 sites in the United States and Canada for the study. Those sites are expected to enroll more than 10,000 patients between the ages of 50 and 84 who are at average risk for colorectal cancer.
