- 74.8% sensitivity and 97.4% specificity demonstrated in cohort of 1,074 patients; results in line with those achieved in the European CE marking study reported in 2011
- BioChain filed for regulatory approval of Epi proColon® with the CFDA, expecting commercialization of the test to start in 2015
Berlin (Germany), Germantown, MD, and Newark, CA (U.S.A.), Beijing (China) – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, and BioChain Institute Inc. (BioChain), a leading clinical diagnostics company in cancer and genetic tests in China and the U.S.A., today announced that BioChain has completed its major clinical validation study to validate Epigenomics’ blood-based Septin9 screening assay Epi proColon® for the early detection of colorectal cancer (CRC) with the goal to gain market approval for the test in China. In addition, BioChain has officially submitted an application to China Food and Drug Administration (CFDA) in April for the approval of Epi proColon®. Both companies expect commercialization of the test in China to start in 2015.
The clinical validation study was designed to evaluate the clinical performance of Epi proColon® for the detection of CRC and is part of the required data package to seek regulatory approval in China. From November 2013 to March 2014, a total of 1,074 patients at three top ranking hospitals in China were tested by using Epigenomics’ Epi proColon® 2.0 CE assay. Epi proColon® detected 74.8% of the cancer cases (sensitivity) and correctly identified 97.4% of the patients free of disease (specificity). The tested study cohort included 300 cancer cases in stages I to IV. The results were marked as positive when at least two out of three samples of the test triplicate were evaluated as positive.
The results were in line with those achieved in Epigenomics’ European CE marking study reported in 2011, which followed the same principle of data interpretation (80% sensitivity and 99% specificity).
Grace Tian, CEO of BioChain, commented: “We are excited about the excellent performance of Epi proColon® in this clinical trial. These results and the filing for regulatory approval of Epi proColon® with the CFDA are significant milestones towards commercialization of this sophisticated cancer screening test in the Chinese market. We strongly believe that the convenience and the simplicity of the blood-based Epi proColon® test will pave the way to significantly improve CRC screening in China.”
Dr. Thomas Taapken, CEO/CFO of Epigenomics, added: “We are thrilled that BioChain completed this clinical study sooner than anticipated, which expresses their strong commitment and enthusiasm to bring our test into the Chinese market. CRC has a very good prognosis if detected at an early stage. Regular screening for cancer, therefore, is highly desirable. We are proud to contribute to implement CRC screening based on a convenient blood-based test to reduce incidence and mortality of the disease in China.”
This was the first clinical study to demonstrate the clinical utility of the Septin9 assay in China. In accordance with internationally accepted 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 report published in December 2013, 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.
A successful cooperation
In March 2013, BioChain licensed Epigenomics’ methylated Septin9 marker for the blood-based detection of colorectal cancer (CRC). The collaboration was significantly expanded in October 2013 when BioChain acquired an exclusive license to develop and commercialize Septin9 IVD for CRC screening in the Chinese market and took a stake in the company.
Both companies are also working together on the validation of other methylation biomarkers in the cancer field. Epigenomics owns intellectual property around a variety of cancer diagnostic markers for lung, prostate and bladder cancer as well as for other solid tumors and markets a CE marked product for lung cancer diagnosis based on its proprietary SHOX2 biomarker. BioChain’s advanced sample preparation technology is a valuable asset for the clinical validation of Epigenomics’ other DNA methylation cancer markers. Should the companies develop any future products, BioChain shall have the option to acquire commercialization rights for the Chinese market, while Epigenomics will retain rights for the rest of the World.
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Epigenomics (www.epigenomics.com) 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 is under regulatory review by the FDA for the U.S.A. and the CFDA for China. 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.
BioChain (www.biochain.com, www.biochainbj.com) 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. Technology platforms employed by BioChain include karyotyping analysis of cytogenetics, fluorescent in-situ hybridization (FISH), array comparative genomic hybridization (aCGH), quantitative PCR (qPCR), Sanger sequencing, next generation sequencing (NGS), multiplex ligation-dependent probe amplification (MLPA), and genetic linkage analysis. BioChain has a strong bioinformatics team and established the first Chromosomal Health Database for the Chinese population (www.szjkzd.org:8080/app/auth).
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