BioChain, an early cancer diagnostic company in China, and its strategic commercialization partner, Epigenomics AG, a German- announced that testing based on the proprietary Septin9 biomarker was included in the Chinese guideline on screening, endoscopic diagnosis and treatment of early colorectal cancer (CRC).

The guideline, recently officially published in the Chinese Journal of Digestive Endoscopy, is defined by the Chinese Society of Digestive Endoscopy of the Chinese Medical Association and the Oncologic Endoscopic Committee of the Chinese Anti-Cancer Association.

The guideline recommends the ‘plasma Septin9 gene DNA methylation assay (mSEPT9)’ and the ‘fecal occult blood test’ as the standard tests for early CRC screening. It is clearly stated that ‘the Septin9 DNA methylation assay has obtained the approval from the China Food and Drug Administration (CFDA) with a sensitivity of 74.8 per cent and a specificity of 97.5 per cent, and it can be used for clinical early detection and diagnosis of CRC’.

More than 50 experts from digestive endoscopy, surgery, oncology, pathological and other disciplines jointly compiled the guideline, which is supported by 161 publications.

As the first CE-marked and CFDA-approved product in clinical methylation gene detection in China, Epigenomics’ blood-based Septin9 test Epi proColon has a strong level of patent protection in several jurisdictions globally, including China, where both the marker itself and the technology used for its detection are widely protected by granted and pending patents. Both parties, BioChain and Epigenomics remain highly committed to take all necessary steps to enforce these IP rights that will protect and strengthen BioChain’s market exclusivity in China.

Grace Tian, chief executive officer of BioChain, commented “We are delighted by the decision to include the Septin9 test in the screening guidelines, which allows us to address CRC detection in China with our blood-based Septin9 test Epi proColon. The guideline is defined by 50 renowned Chinese specialists and further emphasizes the importance of improving early cancer screening, diagnosis and intervention. 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.”

“We are extremely pleased that the Septin9 test, the underlying principle of Epigenomics’ key blood-based product Epi proColon, has been included in the Chinese screening guideline,” added Epigenomics’ CEO/CFO Dr. Thomas Taapken.

“We are convinced that an early detection of the disease through the Septin9 test will help to reduce the mortality and costs of care associated with CRC in China.”

In accordance with various international guidelines, nearly 290 million people are currently eligible for CRC screening in China and effective testing methods that are accepted by patients are needed. CRC is a rapidly growing medical problem. In a recently published report, the independent market research firm Decision Resources estimates that the number of incident cases of CRC in urban areas of China will almost double between 2012 and 2022. As this is demanding for better, simple to use and affordable screening methods, the Chinese government has elected CRC screening as one of its key focus areas in cancer prevention.

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