PRESEPT is a multi-center clinical study sponsored by Epigenomics to prospectively evaluate the clinical performance of Epigenomics’ proprietary biomarker, ^mSEPT9, for colorectal cancer detection in guideline-eligible individuals as defined by the U.S. Multisociety Task Force on Colorectal Cancer (CRC). It is one of the first studies ever to evaluate the performance of a non-invasive test to indicate presence of colorectal cancer in usually asymptomatic individuals in a standard blood sample. The study is designed to enroll up to 7,500 asymptomatic subjects aged 50 or older at average to increased risk for colorectal cancer who have been scheduled for a regular screening colonoscopy at multiple clinical sites in the U.S. and Germany. This population is expected to harbor about 50 cases with undetected colorectal cancer.

The study is intended to evaluate the performance characteristics of the ^mSEPT9 biomarker to determine whether it will meet the requirements of current U.S. guidelines for non-invasive screening tests. The study is further expected to define the health economic benefit to support future coverage by public and private health insurers worldwide. Epigenomics intends to make available to industry partners developing ^mSEPT9 IVD tests access to the PRESEPT samples and data to perform pivotal clinical trials necessary to obtain regulatory approvals.

Each subject enrolled in the study will provide a blood sample prior to pre-colonoscopy bowel cleansing which will be analyzed for methylated of the Sept9 gene. The primary study endpoint will compare the Septin9 test results to the presence or absence of colorectal cancer as determined by colonoscopy, the diagnostic gold standard, and confirmed by histopatholical analysis of tissue removed during the colonoscopic or surgical removal of tissue.

The results of the PRESEPT Study are expected either late in 2009 or early 2010. 

Epigenomics, the sponsor of the PRESEPT Study, believes that a blood-based assay based on aberrant methylation of the SEPT9 gene, offers significant advantages to currently available screening methods. If colorectal cancer screening tests based on this marker perform as expected and are widely adopted, a reduction in morbidity and mortality, as well as demonstration of a positive health economic benefit may be expected. The latter conclusion is based on the observation that patients who deny other less convenient or more invasive screening methods routinely accept standard peripheral blood draws, particularly when the blood draw is grouped with draws for other routine diagnostic tests. As a result of increased acceptance, more eligible average risk people would be screened, and if Septin9 test positive would be referred to colonoscopy where CRC would be detected. This would result in disease being detected earlier, when curable, and thus substantially reduce deaths from this disease.

The PRESEPT Study is registered with clinicaltrials.gov (Study-ID: NCT00855348)

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