NEW YORK (GenomeWeb News) – NextPharma will manufacture Epigenomics' colon cancer test for certain markets worldwide, the firms announced today.
Under terms of the deal, NextPharma will manufacture Epigenomics' Epi proColon test kit in Europe and other markets and will manufacture a cGMP-compliant version of the test, which is currently under development, for the US market.
The test, which identifies the presence of methylated DNA of the Septin9 gene, is CE-marked in Europe. Berlin, Germany-based Epigenomics plans to file for US marketing clearance of the test next year.
Surrey, UK-based NextPharma will manufacture the Epi proColon test at its facilities in San Diego, which are ISO 13485 certified for manufacturing medical devices.
"In NextPharma we have found the ideal contract manufacturing partner to satisfy the increasing demand for our Epi proColon test kit in Europe," Uwe Staub, SVP of product development for Epigenomics, said in a statement.
Financial and other terms of the agreement were not disclosed.