Date: 2014-03-05
Type of information:
phase:
Announcement: results
Company: Epigenomics (Germany - USA)
Product: Epi proColon® 2.0 CE (septin9 test)
Action mechanism:
Disease: colorectal cancer detection
Therapeutic area: Cancer - Oncology
Country: Czech Republic
Trial details:
Latest
news: * On March 5, 2014, 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 “Vnit? 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. Zden?k 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.
