Blood-based IVD is already CE-marked in Europe, with FDA submission planned for 2011.
U.K.-based CMO NextPharma Technologies won a global contract for the commercial manufacture of Epigenomics’ Epi proColon blood-based in vitro diagnostic for the detection of colorectal cancer. The test has already been CE-marked in the EU, and a regulatory submission for the product is projected to be filed with FDA during 2011.
Under terms of its deal with Epigenomics, NextPharma will manufacture Epi proColon for worldwide markets, including a GMP-compliant product for the test currently under development in the U.S. Production will be carried out at the firm’s U.S. facility in San Diego, CA.
Epigenomics’ Epi proColon test detects a methylated Septin9 (mSEPT9) gene in a patient blood sample as an indicator of colorectal cancer. The firm says the test is the world’s first molecular diagnostic test for detecting colorectal cancer to receive regulatory approval.
NextPharma offers services for product development, contract manufacturing, and cold chain and logistics outsourcing to the pharmaceutical and biotechnology industries. A full range of services is available spanning early-phase product development and manufacturing of investigational medicinal products, through to clinical-trial packaging (Phases I through III) to high-volume commercial manufacturing.
The firm claims to have particular expertise in lyophilization, sterile fill/finish and pellet technologies, and specialist product manufacturing including cytotoxics, hormones, penicillins, cephalosporins, and controlled drugs. NextPharma operates globally with seven product-development centers, seven manufacturing plants, and six temperature-controlled storage and distribution sites across Europe and North America to supply customers in North America, Europe, and Japan.