Epigenomics AG, the cancer diagnostics company, announced that new data obtained in a clinical study with the Company's proprietary Septin9 biomarker for the blood-based detection of colorectal cancer, were presented yesterday at the 18th United European Gastroenterology Week (UEGW) in Barcelona, Spain.
“Further investigations will look into acceptance and uptake to determine whether the Septin9 test will help to get more people screened for colorectal cancer as well as cost-benefit aspects.”
The new data were presented by Dr. Juergen Beck, MD, who recently joined Epigenomics as Senior Vice President Medical Affairs, and validate findings in the successfully completed prospective PRESEPT Study, also presented at the conference.
In the PRESEPT Study, Epigenomics' proprietary Septin9 blood test detected 67% of the colorectal cancer cases at a specificity of 88% when compared to colonoscopy, the gold standard in colorectal cancer detection. PRESEPT is a prospective evaluation of the Septin9 biomarker in a study cohort representative of the screening population for colorectal cancer. Almost 8,000 individuals undergoing colonoscopy for routine colorectal cancer screening were enrolled at 32 clinical sites in the US and Germany over a period of about 18 months in this benchmark study. The study was sponsored by Epigenomics, the discoverer of the Septin9 biomarker. It is the largest privately sponsored study in colorectal cancer screening ever conducted.
In his poster presentation Dr. Beck further presented data obtained in a smaller case-control study following the large PRESEPT Screening Study to independently validate the diagnostics assay that had been used in the PRESEPT Study. Investigators in an independent third-party laboratory analyzed cancer cases and colonoscopy-negative controls following the PRESEPT testing protocol. Within this study, the data of which have not been presented before, a sensitivity of 86% and a specificity of 93% were observed.
"The prospective PRESEPT Study has established that a plasma-based marker can be used to detect colorectal cancer in asymptomatic individuals," concluded Prof. Dr. Thomas Roesch, Medical Director of the Department of Interdisciplinary Endoscopy at the University Hospital Hamburg-Eppendorf and Study Director of PRESEPT in Germany. "Further investigations will look into acceptance and uptake to determine whether the Septin9 test will help to get more people screened for colorectal cancer as well as cost-benefit aspects."
Prof. Roesch was chairing a round table of international colorectal cancer screening experts to review and discuss the results of the PRESEPT Study. The round table was jointly organized by Epigenomics and its commercialization partner Abbott Molecular and took place in Barcelona concurrent with the UEWG. Both companies offer CE-marked in vitro diagnostic (IVD) test for the detection of the Epigenomics' proprietary Septin9 biomarker in blood plasma as an aid in the detection of colorectal cancer in Europe and Asia/Pacific. Epigenomics and Abbott Molecular are also working on making Septin9 assays available as FDA-cleared IVD test kits for the US market.
"The PRESEPT Study and the independent validation of the assay system used demonstrates the clinical utility of Septin9 testing as an aid in the detection of colorectal cancer when followed up with colonoscopy and underscores once again the unique potential of our proprietary Septin9 biomarker," commented Geert Nygaard, Chief Executive Officer of Epigenomics. "As a single biomarker test, the Septin9 test compares very favorably in terms of clinical performance and simplicity of handling and interpretation to emerging competing molecular diagnostic approaches to stool and blood testing for colorectal cancer."