Results of Comparative Study Between Epigenomics AG Epi proColon® and FIT to be Presented at Digestive Disease Week
Published: May 15, 2013
Berlin, Germany, and U.S.A., May 15, 2013 - Epigenomics AG (Frankfurt Prime Standard: ECX), the German-American cancer molecular diagnostics company, today announced that results of the head-to-head comparative study between its blood-based colorectal cancer (CRC) detection test Epi proColon® and fecal immunochemical testing (FIT) will be presented at a workshop of the WEO (World Endoscopy Organization) Colorectal Cancer Screening Committee during this year’s DDW (Digestive Disease Week) Conference in Orlando, FL, U.S.A., on May 17, 2013.
• Epi proColon® demonstrates 74% sensitivity in CRC detection and is non-inferior to FIT • Blood-based test has potential to increase patient acceptance in CRC screening according to Prof. David Johnson
The results will be presented by Nicholas Potter, Ph.D., Molecular Pathology Laboratory Network, Inc. Maryville, TN, U.S.A., on behalf of the authors, including lead author David A. Johnson, Gastroenterology Division, Eastern VA Medical School, Norfolk, VA, U.S.A., one of the leading gastroenterologists in the US and co-author of several CRC screening guidelines including those of the US Multisociety Task Force and the American College of Gastroenterology.
In the final analysis of the study results, it was demonstrated that Epi proColon® was able to detect 74% of all evaluable CRC cases in this large multi-centric clinical study, in comparison to 67% of CRC cases detected by FIT. Nicholas Potter concluded that it was demonstrated that sensitivity of the plasma-based methylated Septin9 test is statistically non-inferior to a widely recommended stool-based screening test (FIT).
Analysis of Septin9 DNA methylation in plasma represents a straightforward, minimally invasive method to detect all stages of CRC which either alone or in combination with other screening strategies has the potential to satisfy unmet needs for increased compliance in the screening population. Prof. Johnson commented: “This technology introduces a new opportunity to increase patient acceptance and compliance with CRC screening. Anything that increases screening should be viewed as a favorable advance in the goal to decrease CRC mortality.“
Dr. Uwe Staub, Chief Operating Officer of Epigenomics, commented: “We are very pleased with the final study results, which have now been under review by the FDA since earlier this year. Participation in CRC screening programs and acceptance of recommended methods, including non-invasive stool-based tests, are still too low. Based on the achieved non-inferiority in CRC detection, we believe that Epi proColon® has the potential to significantly drive awareness and acceptance for CRC screening among those who would otherwise be non-compliant.”
WEO Colorectal Cancer Screening Committee Meeting, DDW Workshop 2013:
The presentation titled “Use of FIT versus Septin 9: Trial results” presented by Nicholas T. Potter will be held at the WEO (World Endoscopy Organization) Colorectal Cancer Screening Committee Meeting, DDW 2013 Workshop, in Orlando, FL, U.S.A. on Friday, May 17, 2013 during the session “Updates on Screening Methods/ New Tests” which is scheduled for 3.30 pm to 5.10 pm.
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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 and testing laboratories. Epigenomics is an international company with operations in Europe and the U.S.A.
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