Exact Sciences (Nasdaq: EXAS) today announced the initiation of the pivotal trial for the company's multi-marker molecular diagnostic screening test for the early detection of colorectal cancer. The 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 Exact Sciences' planned PMA submission to the U.S. Food and Drug Administration (FDA). The company began enrolling patients in the study on June 30th, 2011. Exact Sciences is planning to have approximately 60 sites in the United States and Canada participate in 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.
Colorectal cancer is the second leading cancer killer in the United States. It is often considered the most preventable, yet least prevented cancer. Colorectal cancer is highly treatable if found early, but 40 percent of adults age 50 and older have not been screened as recommended.
"The Exact Sciences test could be an important tool in the fight against colorectal cancer. The DeeP-C trial is an opportunity to prospectively demonstrate the test's effectiveness in a large average risk patient population," said principal study investigator Thomas Imperiale, M.D. professor of medicine and associate director for research for the division of gastroenterology at Indiana University School of Medicine. "Colorectal cancer is a treatable disease if caught early, and this test shows promise as a potential addition to other available screening tools."
The latest American Cancer Society colorectal cancer screening guidelines include sDNA testing as a recommended screening option. The Exact CRC screening test, 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 pre-cancerous 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.
"We look forward to the results of this clinical trial. There remains a significant unmet medical need to provide additional options for patients at average risk for CRC. We believe this test could become a great tool for the early detection of this terrible disease and help many of the thousands of patients who are currently not getting screened," said Kevin T. Conroy, president and chief executive of Exact Sciences.
Rare genetic mutations in healthy women may be key to breast cancer origins