16.02.2012 | 120216_Epigenomics_Press_release_Septin9
Berlin, Germany, and Seattle, WA, U.S.A., – Epigenomics AG (Frankfurt Prime Standard: ECX), the German-American cancer molecular diagnostics company, is pleased to announce the results from a study conducted in collaboration with Professor Dr. Béla Molnár and his team from the 2nd Department of Internal Medicine of Semmelweis University in Budapest, Hungary. In the study, the blood based detection of methylated Septin9 in colorectal cancer (CRC) cases was assessed in the left and right side of the colon.
In a blinded case control study of a total of 184 study participants, plasma from 92 CRC cases (56 left-, 36 right-sided cases) was analyzed and methylated Septin9 was detected in a total of 88 cancer cases, representing 96% sensitivity for overall CRC detection at a specificity of 85%. The control arm consisted of 92 samples of individuals with no evidence of disease as verified by colonoscopy. Sensitivity for detection of left- and right-sided cases was 96% and 94% respectively, thus showing no significant difference between cancer detection in either side of the colon.
In a subset of 39 subjects that received a fecal occult blood test (FOBT, Hemoccult II stool test) in addition to a Septin9 test, the sensitivities for FOBT for the detection of 12 left- sided cases was 83% and 50% for the 10 right-sided cases in this study. Overall, sensitivity for FOBT was 68% and specificity was 71%.
The complete data will be submitted by Prof. Molnár for publication in a peer reviewed journal in due course.
Dr. Jürgen Beck, Senior Vice President of Medical Affairs commented: “These results are in line with previously reported performance evaluations for CRC detection in case control studies performed by Epigenomics and other parties. They reflect the value and the superiority of blood based testing of methylated Septin9 for early detection of colorectal cancer, independently of the localization of the cancerous lesion”
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Epigenomics (www.epigenomics.com) is a molecular diagnostics company developing and commercializing a pipeline of proprietary products for cancer. The Company’s products enable doctors to diagnose cancer earlier and more accurately, leading to improved outcomes for patients. Epigenomics’ lead product, Epi proColon®, is a blood-based test for the early detection of colorectal cancer, which is currently marketed in Europe and is in development for the U.S.A. The Company’s technology and products have been validated through multiple partnerships with leading global diagnostic companies including Abbott, QIAGEN, Sysmex, and Quest Diagnostics. Epigenomics is an international company with operations in Europe and the U.S.A.
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