ARTICLE | Clinical News

SEPT9 Test: Updated pivotal trial data

March 15, 2010 7:00 AM UTC

Updated top-line data from the U.S. and German pivotal PRESEPT trial in 7,941 subjects showed that the SEPT9 Test had an overall cancer detection rate of about 63%, with 89% specificity as measured on colonoscopy verified subjects without any apparent disease. Epigenomics said the data meet the trial's primary objective of detecting the majority of prevalent and incident cancers in a screening cohort, a requirement for noninvasive screening tests in current joint guidelines from the American Cancer Society, the U.S. Multi-Society Task Force on Colorectal Cancer and the American College of Radiology. The study population contained 53 confirmed cases of previously unsuspected colorectal cancer that were identified by screening colonoscopies performed on all subjects. ...