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 FDA (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 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' CE marking study reported in 2011, which followed the same principle of data interpretation (80% sensitivity and 99% specificity).
In March 2013, BioChain licensed Epigenomics' methylated Septin9 marker for the blood-based detection of CRC. The collaboration was significantly expanded in October 2013 when BioChain acquired an exclusive licence to develop and commercialise Septin9 IVD for CRC screening in the Chinese market and took a stake in the company. Both companies are also working together on the validation of other methylation biomarkers in the cancer field.