Epigenomics AG: New Clinical Data for Septin9 Colorectal Cancer Blood Test
Independent validation of laboratory test used in PRESEPT Study shows that the test finds 86% of the cancers
Epigenomics AG 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 at the 18th United European gastroenterology Week (UEGW) in Barcelona, Spain. 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.
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.
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