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Epigenomics announces findings from clinical study of blood-based Septin9 test in colorectal cancer screening

Epigenomics, the German-American cancer molecular diagnostics company, has announced findings from a study executed in different centers in Prague, Pilsen, and Brno.

According to the study published in ‘Vnitr Lék’, a Czech journal for internal medicine, in late 2013 blood-based Septin9 testing could be an attractive screening alternative to established methods for a population that would otherwise be non-compliant to colorectal cancer screening. The study was conducted by Thomayer Hospital, Prague Medical department head Dr Zdenek Beneš.

The case control study comprised 57 patients; 33 asymptomatic individuals with negative colonoscopies, and 24 patients with proven adenomas. In this study, Epi proColon 2.0 CE showed a sensitivity of 92% and a specificity of 97%.

These results are in line with the results achieved in the CE marking study reported in 2011, which followed the same principle of data interpretation (80% sensitivity and 99% specificity).

According to the authors of the publication, Septin9 testing can be seen as an attractive alternative to existing CRC screening methods in areas where sufficient compliance to CRC screening programs is currently not achieved.

Established screening methods, including fecal occult blood testing (FOBT), fecal immunochemical testing (FIT), flexible sigmoidoscopy and colonoscopy are effective and cost-efficient, however, have not reached the effect required based on low patient participation.

The benefits of blood-based Septin9 testing over current standard procedures can be seen in the higher convenience for patients given that the test just requires simple blood draw, the non-invasive nature of the test which can be part of routine physician visits and its ability to detect carcinoma independent of its location.
Epigenomics CEO/CFO Dr Thomas Taapken noted CRC has a very good prognosis if detected in early stages.

"Regular screening and early detection of cancers therefore is highly desirable, but screening programs in many countries have very low compliance rates. Screening programs based on a convenient blood test have the potential to significantly improve uptake and adherence and ultimately reduce CRC incidence and mortality as well as resulting healthcare cost."