Berlin (Germany), Germantown, MD, and Newark, CA (U.S.A.) and Beijing (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.”
“We are extremely pleased to announce the approval of Epi proColon® in the important Chinese market. BioChain has been incredibly efficient in driving this approval process in a very short time. We now look forward to working closely with our partner BioChain on the launch of this very important diagnostic tool,” added Epigenomics’ CEO/CFO Dr. Thomas Taapken. “We are convinced that our test will help to reduce the mortality and costs of care associated with CRC in China through the early identification of the disease.”
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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 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.
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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