Last Update: 19-Mar-14 07:25 ET
Exact Sciences shares soar 13% following Cologuard clinical results
- Exact Sciences (EXAS $16.40 +1.98): Results of a clinical trial of Cologuard show unprecedented rates of precancer and cancer detection by a noninvasive test. The detection rates are similar to those reported for colonoscopy. The results were published in the March 20 issue of the New England Journal of Medicine (NEJM). Cologuard was co-developed by Mayo Clinic and Exact Sciences. In the study, all patients received Cologuard, FIT and colonoscopy. Colonoscopy was the reference method. Major findings reported in the study include: Sensitivity of Cologuard for cancer was 92 percent overall, and 94 percent for the earliest and most curable cancer stages (stages I and II).
- Sensitivity was 69 percent for precancerous polyps at greatest risk to progress to cancer (i.e., those containing high-grade dysplasia). Cologuard detected significantly more cancers and significantly more precancerous polyps than did FIT. The post has been removed from the Mayo Clinic website. The press release is expected to be released tomorrow at 5:00 p.m. ET..
- Background information from Briefing.com: In November 2012 EXAS completed enrollment of its DeeP-C pivotal trial for colorectal cancer screening. The results of the trial are expected to form the basis for submitting the non-invasive test for Pre-Market Approval with the FDA. Exact submitted the first module of the PMA application in early December 2012, and the second module in mid-February, 2013. Results of the DeeP-C trial will be reported when available
Exact Sciences (EXAS $16.40 +1.98): Results of a clinical trial of Cologuard show unprecedented rates of precancer and cancer detection by a