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China Approves Epigenomics Colorectal Cancer Test

NEW YORK (GenomeWeb) – Epigenomics and BioChain today announced the Epi proColon colorectal cancer detection test has been approved for marketing by regulators in China. 

The approval from the China Food and Drug Administration follows the completion of a clinical validation study by BioChain earlier this year that found the non-invasive blood-based test detected 75 percent of all cancer cases at 97.5 percent specificity. BioChain anticipates launching the test in the next few weeks through its distribution channels. 

The partners said that the availability of Epi proColon has the potential to expand colorectal cancer detection in China, "providing an early diagnostic tool to lower the CRC morbidity and mortality and reduce the cost in CRC prevention and therapy," while also increasing awareness of the importance of early screening, diagnosis, and intervention, "therefore enhancing the health of all Chinese people," BioChain Chairman James Wang said in a statement. 

Epigenomics is also seeking regulatory approval of the test by the US Food and Drug Administration. In June the company received a letter from the agency saying Epi proColon is not approvable. Since then, it has completed the design of the Adherence to Minimally Invasive Testing (ADMIT) study, which aims 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.