Epigenomics and BioChain enter into collaboration in China

29-Oct-2013 - China

Epigenomics AG and BioChain announced that the companies 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$ 1.3m (EUR 0.94m) into Epigenomics.

As part of the agreed collaboration, which significantly expands the license agreement for a laboratory developed test announced earlier this year, BioChain will acquire an exclusive license to develop and commercialize 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. In order to execute the clinical trial, BioChain has placed an order for 5,000 Epi proColon® tests with Epigenomics. The trial will start in Q4 2013 and is expected to be completed in the 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.

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