Epigenomics AG and NextPharma Sign Global Manufacturing Deal for Colorectal Cancer Blood Test
Epigenomics AG and NextPharma Technologies announced that the companies have signed a global manufacturing contract for Epigenomics' Epi proColon product. Epi proColon, currently marketed in Europe, is the world's first in-vitro diagnostic test for the detection of colorectal cancer in a simple blood draw.
Under the terms of the agreement between the companies, NextPharma will manufacture Epigenomics' CE-marked Epi proColon test kit for European and other markets according to the ISO 13485 for medical devices and will manufacture a cGMP-compliant version for the US market that is currently under development. Epigenomics plans to submit a marketing application to the US Food and Drug Administration (FDA) for the Epi proColon test in 2011.
"In NextPharma we have found the ideal contract manufacturing partner to satisfy the increasing demand for our Epi proColon test kit in Europe," commented Dr. Uwe Staub, Senior Vice President Product Development at Epigenomics. "With its high quality standards and depth of experience in medical device manufacturing NextPharma is also ideally positioned to manufacture our future US product."
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