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Epigenomics' Epi proColon Test Included in China's Colorectal Cancer Screening Guideline

NEW YORK (GenomeWeb) – Epigenomics and its commercialization partner in China, BioChain, today said that Epigenomics' Epi proColon test has been included in China's screening guideline for colorectal cancer. 

According to the firms, the guideline recommends the use of the Septin-9 DNA methylation assay as the standard of care for early colorectal cancer screening. The Chinese Food and Drug Administration approved the test, which has a sensitivity of 74.8 percent and a specificity of 97.5 percent, for marketing in the country in December.

The firms noted that nearly 290 million people are currently eligible for CRC screening in China. 

"This is a major milestone to reach a consensus on the strategy of CRC prevention and diagnosis, and to ensure effective screening and early diagnosis of CRC," BioChain CEO Grace Tian said in a statement. 

Epigenomics is currently seeking approval from the US FDA to market Epi proColon in the US. In June 2014, the agency said that the real-time PCR-based test was not approvable. The company has since launched the ADMIT trial to demonstrate that the test will increase the participation of patients in colorectal cancer screening when offered the test compared to those offered fecal immunochemical testing.