EpigenomicsBioChain結直腸癌早期檢測試劑盒獲CFDA批準



2014年12月12/生物谷BIOON/--Epigenomics和BioChain近日宣布中國食品藥品監督管理局(CFDA)批準了Epi proColon在中國銷售。Epi proColon是針對結直腸癌的非侵入性血液診斷測試贵州快3开奖结果、Septin9基因甲基化檢測試劑盒。

該批準是基于2014年5月份BioChain完成的關鍵性臨床驗證贵州快3开奖结果,證明了Epi proColon在臨床檢測中的出色表現。這個外周血癌癥篩查產品可以檢測出75%的癌癥,特異性達97.5%,極有潛力成為中國建立和擴大結直腸癌篩查的重要工具。由于該項篩查基于血液樣本,簡便易行,可以使得更多的受試者參與到結直腸癌篩查工作,為減少晚期癌癥病例、降低治療成本提供支撐贵州快3开奖结果贵州快3开奖结果。Epigenomics在中國的合作伙伴BioChain希望下周通過已建成的銷售管道把該試劑盒推向中國市場,目前BioChain正在積極籌備銷售。

BioChain的董事長James Wang表示,Epi proColon受CFDA批準是一件大好消息,對公司具有里程碑式的意義贵州快3开奖结果。該試劑盒具有高靈敏性和特異性,能夠滿足中國人群和社會對結直腸癌檢測的需要。Epi proColon不僅可以為降低結直腸癌發病率和死亡率提供早期診斷方法贵州快3开奖结果,而且可以增強大眾增強早期篩查、診斷和干預的意識贵州快3开奖结果,從而促進民眾的健康。目前公司正在積極推廣Epi proColon在中國的結直腸癌篩查中的應用。

關于Epigenomics

Epigenomics是一家分子診斷公司贵州快3开奖结果,專業開發和銷售癌癥相關的專利產品。該公司的產品主要是用于癌癥的早期精確檢測。Epigenomics的主打產品Epi proColon是一款用于結直腸癌早期篩查的血液檢測試劑盒,目前主要市場是歐洲。該產品剛剛獲得CFDA的批準,并正在FDA審批過程中贵州快3开奖结果。此外Epigenomics目前還在歐洲市場銷售肺癌組織檢測試劑盒Epi proLung,該公司的產品受到許多診斷巨頭和合作伙伴贵州快3开奖结果、實驗室的認證贵州快3开奖结果贵州快3开奖结果。Epigenomics是一家主要在歐洲和美國運營的跨國企業。

關于BioChain

BioChain是一家設立在美國和中國的生物技術工具和先進分子診斷試劑制造商贵州快3开奖结果。BioChain擁有和運營自己獨立的實驗室,北京BioChain醫學實驗室贵州快3开奖结果。該實驗室主要是研究分子診斷相關的技術和產品,主要在生殖健康和癌癥領域從事組學研究,還為多種階段和類型疾病的檢測提供細胞和分子水平的技術服務。(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贵州快3开奖结果, 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贵州快3开奖结果, Epi proColon, is a blood-based test for the early detection of colorectal cancer贵州快3开奖结果, 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贵州快3开奖结果, 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




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