Clinical Study Confirms Blood-Based Septin9 Test to be an Attractive Alternative for CRC Screening Programs

Study shows non-invasive, PCR blood test Septin9 might help to increase early colorectal cancer detection

EpiEpigenomics AG, the German-American cancer molecular diagnostics company, today announced findings from a study executed in different centers in Prague, Pilsen, and Brno. According to the study published in “Vnitř Lék”, a leading 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 MU Dr. Zdeněk Beneš, CSc., Head, Medical department of Thomayer Hospital, Prague.

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.

“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,” commented Dr. Thomas Taapken, CEO/CFO of Epigenomics. “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.”

According to the study, the Czech Republic belongs to the European countries with the highest incidences of colorectal cancer. 94.4 new cases per year are diagnosed in men and 46 in women per 100,000 inhabitants. In the Czech Republic the compliance with a nationwide two-phase screening program based on the detection of occult blood in stool (FOBT) in the asymptomatic population above 50 years was only 22.7% in 2010. Therefore, alternative solutions to improve CRC detection are currently evaluated in the Czech Republic.

The Epi proColon Early Detection Assay is based on detecting aberrantly methylated DNA of the v2 region of the Septin9 gene (SEPT9) in blood plasma.