Epigenomics, the German-American cancer molecular diagnostics company, and BioChain Institute, a leading clinical diagnostics company in cancer and genetic tests in China and the USA have announced that BioChain has completed its major clinical validation study to validate Epigenomics' blood-based Septin9 screening assay Epi proColon for the early detection of colorectal cancer (CRC) with the goal to gain market approval for the test in China. In addition, BioChain has officially submitted an application to China Food and Drug Administration (CFDA) in April for the approval of Epi proColon. Both companies expect commercialisation of the test in China to start in 2015.
The clinical validation study was designed to evaluate the clinical performance of Epi proColon for the detection of CRC and is part of the required data package to seek regulatory approval in China. From November 2013 to March 2014, a total of 1,074 patients at three top-ranking hospitals in China were tested by using Epigenomics' Epi proColon 2.0 CE assay. Epi proColon detected 74.8% of the cancer cases (sensitivity) and correctly identified 97.4% of the patients free of disease (specificity). The tested study cohort included 300 cancer cases in stages I to IV. The results were marked as positive when at least two out of three samples of the test triplicate were evaluated as positive.
The results were in line with those achieved in Epigenomics' European CE marking study reported in 2011, which followed the same principle of data interpretation (80% sensitivity and 99% specificity).
Grace Tian, CEO of BioChain, commented: 'We are excited about the excellent performance of Epi proColon in this clinical trial. These results and the filing for regulatory approval of Epi proColon with the CFDA are significant milestones towards commercialisation of this sophisticated cancer screening test in the Chinese market. We strongly believe that the convenience and the simplicity of the blood-based Epi proColon test will pave the way to significantly improve CRC screening in China.'
