Epigenomics AG
Systematic study review supports use of Epi proColon(R) in blood-based cancer detection
Press release |
Meta-analysis published in renowned journal "Clinical and Translational Gastroenterology"
Berlin (Germany) and Germantown, MD (U.S.A.), January 30, 2017 - Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), announced that the scientific results of a recent systematic review and meta-analysis of clinical studies with Epi proColon were published in "Clinical and Translational Gastroenterology", a journal of the Nature Publishing Group.
After analyzing results from 25 independent studies from different geographical areas, the authors conclude that methylated Septin 9 detected by the Epi proColon test "is a reliable blood-based marker in colorectal cancer detection". The second generation Epi proColon test received US Food and Drug Administration approval in April 2016 and as reported in the FDA trials, has a sensitivity of 68% at specificity of 80% in the average risk U.S. population.
Greg Hamilton, Chief Executive Officer of Epigenomics AG, said: "This comprehensive scientific review provides further evidence of Epi proColon's robust performance as measured in different clinical studies. A patient accepted, convenient blood-test like Epi proColon has the potential to increase participation in colorectal cancer screening programs as it lowers existing preparation and sampling barriers for patients."
The full study of Jiayun Nian, MD et al. "Diagnostic Accuracy of Methylated SEPT9 for Blood-based Colorectal Cancer Detection: A Systematic Review and Meta-Analysis" can be accessed on the following website: http://www.nature.com/ctg/journal/v8/n1/full/ctg201666a.html
According to the study results, the test shows high pooled sensitivity and specificity of 71% and 92%, respectively.
* Sensitivity: the percentage of cancer cases correctly identified; Specificity: the percentage of healthy individuals correctly identified as negative
About Epi proColon
For patients, the test only requires a blood sample drawn as part of routine healthcare provider visits. There are no dietary restrictions or alterations in medication required for the test. The sample will be analyzed at a national or regional diagnostic laboratory.