The Presept study is a prospective evaluation of the Septin9 biomarker in a study cohort representative of the screening population for colorectal cancer.

In the study 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, Epigenomics said.

Epigenomics and Abbott Molecular are also working on making Septin9 assays available as FDA-cleared in vitro diagnostic (IVD) test kits for the US market and both companies offer CE-marked IVD test for the detection of the Epigenomics’ Septin9 biomarker in blood plasma as an aid in the detection of colorectal cancer in Europe and Asia/Pacific.

Epigenomics CEO Geert Nygaard said that 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.

“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,” Nygaard said.