Epigenomics&BioChain结直肠癌早期检测试剂盒获CFDA批准

Epigenomics和BioChain近日宣布中国食品药品监督管理局（CFDA）批准了Epi proColon在中国销售。Epi proColon是针对结直肠癌的非侵入性血液诊断测试、Septin9基因甲基化检测试剂盒。

该批准是基于2014年5月份BioChain完成的关键性临床验证，证明了Epi proColon在临床检测中的出色表现。这个外周血癌症筛查产品可以检测出75%的癌症，特异性达97.5%，极有潜力成为中国建立和扩大结直肠癌筛查的重要工具。由于该项筛查基于血液样本，简便易行，可以使得更多的受试者参与到结直肠癌筛查工作，为减少晚期癌症病例、降低治疗成本提供支撑。Epigenomics在中国的合作伙伴BioChain希望下周通过已建成的销售管道把该试剂盒推向中国市场，目前BioChain正在积极筹备销售。

BioChain的董事长James Wang表示，Epi proColon受CFDA批准是一件大好消息，对公司具有里程碑式的意义。该试剂盒具有高灵敏性和特异性，能够满足中国人群和社会对结直肠癌检测的需要。Epi proColon不仅可以为降低结直肠癌发病率和死亡率提供早期诊断方法，而且可以增强大众增强早期筛查、诊断和干预的意识，从而促进民众的健康。目前公司正在积极推广Epi proColon在中国的结直肠癌筛查中的应用。

关于Epigenomics

Epigenomics是一家分子诊断公司，专业开发和销售癌症相关的专利产品。该公司的产品主要是用于癌症的早期精确检测。Epigenomics的主打产品Epi proColon是一款用于结直肠癌早期筛查的血液检测试剂盒，目前主要市场是欧洲。该产品刚刚获得CFDA的批准，并正在FDA审批过程中。此外Epigenomics目前还在欧洲市场销售肺癌组织检测试剂盒Epi proLung，该公司的产品受到许多诊断巨头和合作伙伴、实验室的认证。Epigenomics是一家主要在欧洲和美国运营的跨国企业。

关于BioChain

BioChain是一家设立在美国和中国的生物技术工具和先进分子诊断试剂制造商。BioChain拥有和运营自己独立的实验室，北京BioChain医学实验室。该实验室主要是研究分子诊断相关的技术和产品，主要在生殖健康和癌症领域从事组学研究，还为多种阶段和类型疾病的检测提供细胞和分子水平的技术服务。(生物谷Bioon.com）

原文Epigenomics and BioChain Announce Approval of Epi proColon in China

Epigenomics AG (Frankfurt Prime Standard： ECX， OTCQX： EPGNY)， the German-American cancer molecular diagnostics company， and BioChain， a leading clinical diagnostics company in cancer and genetic testing in China and the U.S.A.， announced today that the China Food and Drug Administration (CFDA) approved Epi proColon for commercialization in China. Epi proColon is Epigenomics' non-invasive blood-based diagnostic test for colorectal cancer (CRC) detection based on the Septin9 DNA methylation marker.

The approval was based on a major clinical validation study completed by BioChain in April 2014， which confirmed the previously demonstrated positive clinical performance of Epi proColon. While detecting 75% of all cancer cases at 97.5% specificity in the Chinese study， this test has the potential to become an important tool for medical professionals in establishing and expanding CRC detection in this country. The availability of CRC screening based on a blood sample will enable higher patient participation in detection of CRC as a means to reduce later stage disease and the associated costs. Epigenomics' partner in China， BioChain， expects to launch the product within the next weeks into the Chinese market through their established distribution channels and is currently preparing its market launch throughout the country.

James Wang， Chairman of BioChain， commented： "We are delighted by the CFDA approval of Epi proColon which is a key milestone for our company， allowing us to address colorectal cancer detection in China with this highly innovative product. We believe this product with high sensitivity， specificity and expected compliance will benefit the Chinese people and society. These benefits will not only be seen in the way of providing an early diagnostic tool to lower the CRC morbidity and mortality and reduce the cost in CRC prevention and therapy， but also by way of emphasizing the importance of early screening， diagnosis and intervention， therefore enhancing the health of all Chinese people. We thank Epigenomics for the excellent support provided during the approval process and we now look forward to bringing this effective and non-invasive option to the people eligible for CRC screening in our country."

About Epigenomics

Epigenomics is a molecular diagnostics company developing and commercializing a pipeline of proprietary products for cancer. The Company's products enable doctors to diagnose cancer earlier and more accurately， leading to improved outcomes for patients. Epigenomics' lead product， Epi proColon， is a blood-based test for the early detection of colorectal cancer， which is currently marketed in Europe， and has received approval by the Chinese Food and Drug Administration for China and is under regulatory review by the U.S. Food and Drug Administration (FDA). Additionally， the Company markets its tissue assay for use in lung cancer diagnosis， Epi proLung？， in Europe. The Company's technology and products have been validated through multiple partnerships with leading global diagnostic companies and testing laboratories. Epigenomics is an international company with operations in Europe and the U.S.A.

About BioChain

BioChain is a manufacturer of Life Sciences tools and the pioneer of molecular genetics diagnostics in the US and China. It is also the owner and operator of an independent reference laboratory， equivalent of a CLIA lab， in China - Beijing BioChain Medical Laboratory (BBML). BBML is unique in that it focuses on the application of molecular diagnostics technologies and products. BBML is located in the economic development zone of Beijing， China. Through BBML， BioChain is committed to the application of the cutting edge "omics" technologies in the areas of reproductive health and cancer diagnosis. BBML offers comprehensive services to its customers in China with a list of cellular and molecular test menus based on diverse technologies appropriate to each stage and type of disease.