AsianScientist (Nov. 5, 2013) – BioChain, a clinical diagnostics company, and Epigenomics AG, a cancer molecular diagnostics company, have announced a collaboration to bring Septin9 colorectal cancer screening technology to China.
BioChain will acquire a license to develop and commercialize Septin9 in vitro diagnostic tests for colorectal cancer (CRC) screening in the Chinese market. Epigenomics will receive minimum annual payments as well as mid single-digit royalty payments once regulators in China approve the product. Until then, Epigenomics will continue selling laboratory developed test components to BioChain.
BioChain will initiate a clinical trial to validate the Septin9 CRC screening assay and 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. It will also demonstrate the clinical utility of the Septin9 assay in China, where nearly 290 million people are currently eligible for CRC screening. CRC is a rapidly growing medical problem in China.
“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 with the simplicity of the Epi proColon® test will pave the way to high participation levels in CRC screening in the Chinese population,” said Grace Tian, CEO of BioChain.
Both companies also agreed to work 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 and for other solid tumors. It also markets a CE-marked product for lung cancer diagnosis based on its proprietary SHOX2 biomarker.
BioChain will have the option to acquire commercialization rights for the Chinese market, while Epigenomics will retain rights for the rest of the world.
“This agreement reached today is the key initial step in translating our blood-based screening assay into a major tool for colorectal cancer management in this important region,” said Dr. Thomas Taapken, CEO of Epigenomics.
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Source: BioChain.
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