Specimens for Septin 9 Performance

Specimen Collection Protocol for the Performance Evaluation of the Septin 9 Assay

Epigenomics has identified methylated gene regions that are specific for colorectal cancer (CRC). Through Epigenomics' marker discovery and validation process Septin 9 was identified as a particularly robust methylation marker for detection of CRC. Epigenomics is currently developing a blood based CRC screening test based on Septin 9 and is performing a large prospective clinical trial showing its clinical utility in a population at average risk for CRC. Parallel to this trial further activities are needed to evaluate, optimize, and develop pre-analytical and analytical workflows as well as molecular assays making possible the use of Septin 9 methylation in the clinical routine.

Inclusion Criteria:

• 50 years of age or older at the time of the blood draw
• Histologically confirmed or strong clinical suspicion of adenocarcinoma of the colon or rectum
• CRC defined as invasive adenocarcinoma

Exclusion Criteria:

• Previous personal history of colorectal cancer
• Any cancer specific treatment (e.g. polypectomy, chemotherapy, radiation, or surgery) prior to blood draw, including neoadjuvant treatment
• Known infection with HIV, HBV or HCV
• Subject concurrently receiving intravenous fluid at the time of the specimen collection