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28 Oct 2013

Epigenomic?s and BioChain Enter into Broad Strategic Collaborat?ion in China and Investment into Epigenomic?s

Epigenomics AG, a German-American cancer molecular diagnostics company, and BioChain, a leading clinical diagnostics company in cancer and genetic tests in China and the US, have signed an agreement regarding a broad strategic collaboration of both companies. In addition, BioChain will acquire 217,935 newly issued shares of the company which corresponds to an investment of US$ 1.3 million (EUR 0.94 million) into Epigenomics. 

As part of the agreed collaboration, which significantly expands the licence agreement for a laboratory developed test announced earlier this year, BioChain will acquire an exclusive licence to develop and commercialise Septin9 in vitro diagnostic (IVD) tests for colorectal cancer (CRC) screening in the Chinese market. Under the terms of the agreement, Epigenomics will receive undisclosed upfront and minimum annual payments, as well as mid single-digit royalty payments once the product is approved by the CFDA. Until then, Epigenomics will continue selling laboratory developed test (LDT) components to BioChain. 

At its own expense, BioChain will initiate a major clinical trial to validate the Septin9 CRC screening assay with the goal to gain market approval for the blood-based test by the CFDA. To execute the clinical trial, BioChain has placed an order for 5000 Epi proColon tests with Epigenomics. The trial will start in Q4 2013 and is expected to be completed inthe second half of 2014.  

This is the first clinical study to demonstrate the clinical utility of the Septin9 assay in China, where, in accordance with internationally accepted guidelines, nearly 290 million people are currently eligible for CRC screening. In ChinaCRC is a rapidly growing medical problem demanding for better, simple to use and affordable screening methods. 

Grace Tian, CEO of BioChain, commented: “Based on our assessment of Epigenomics’ test and its significant market potential, we decided to broaden our existing collaboration. We are pleased to introduce this advanced cancer screening test to China and are convinced that the success of this method in the planned clinical trial combined withthe simplicity of the EpiproColon test will pave the way to high participation levels in CRC screening inthe Chinese population.”  

Dr Thomas Taapken, CEO/CFO of Epigenomics, stated: “We are excited about BioChain’s commitment and vigorous approach to accelerate the development of the Chinese CRC screening market with our biomarker. This agreement ... is the key initial step in translating our blood-based screening assay into a major tool for colorectal cancer management in this important region. We look forward to collaborating closely with our partner BioChain.”

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