Epigenomics' PRESEPT Academic Research Study Meets Its Primary Objective

08-Mar-2010 - Germany

Epigenomics AG reported updated top-line PRESEPT Study data showing that the Septin9 biomarker in this research study detected colorectal cancer cases with a sensitivity of approximately 63% based on 32 colorectal cancer (CRC) cases correctly identified out of 51 cancer cases with valid measurements of Septin9 in blood plasma samples. With this performance the PRESEPT Study has met its objective of detecting the majority of prevalent and incident cancers in a screening cohort, a requirement for noninvasive screening tests set forth in current joint guidelines by the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of radiology. With a specificity of around 89% the Septin9 testing result meets the targeted specificity range of 85% to 90%, which based on an initial health economic analysis, should support public and private payer coverage and reimbursement.

As originally foreseen in the study protocol, the study results were updated upon testing of samples determined to be invalid along with testing of a small number of additional cancer cases identified after the previous testing was initiated. Furthermore, investigative actions were implemented after a preliminary data analysis in January 15, 2010 had indicated that one of the three laboratories performing the Septin9 testing had reported a cancer detection rate that deviated from findings in the other PRESEPT Study testing laboratories and all previous studies. An investigation into these results led to retesting potentially affected samples by the other two labs. In addition a remainder of material leftover from processing of the samples measured in the study was also tested for Septin9 at each of the three independent laboratories and included into the analysis. The combined results from all of the above testing activities contributed to the improved test performance reported.

Epigenomics can now report that the additional testing directed by the PRESEPT Clinical Study Steering Committee (CSSC) has been completed, and the Committee has reported to Epigenomics that the primary objective of the study of identifying the majority of colorectal cancer cases has been successfully met. Although histopathological review and further detailed statistical analysis remain to be completed, the CSSC concludes the results are not inconsistent with case-control studies previously reported and that the data indicate that Septin9 testing may be a useful tool to detect the presence of occult colorectal cancer in a standard plasma specimen obtained from average risk individuals eligible for colorectal cancer screening. Later this year the CSSC will submit the PRESEPT Study results for presentation at a major medical meeting and peer-reviewed publication in a major scientific journal.

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