By Ben Butkus
Epigenomics and life science outsourcing firm NextPharma said this week that they have signed a global manufacturing contract covering Epi proColon, Epigenomics' nucleic acid amplification-based colorectal cancer screening test.
Epigenomics expects the agreement to help meet increasing demand for its test in Europe, where it was introduced with the CE Mark for in vitro diagnostics last October.
In addition, the deal with Surrey, UK-based NextPharma — which has manufacturing facilities in San Diego — may give Epigenomics a stronger foothold in the US for Epi proColon production as the company ramps up to seek 510(k) approval for the test. Epigenomics, based in Berlin, already has offices in Seattle.
Under the agreement, the financial details of which have not been disclosed, NextPharma will manufacture Epi proColon test kits for European and other markets according to the ISO standards for medical device manufacturing.
In addition, NextPharma will manufacture a cGMP-compliant version of the kit for sale in the US, where Epi pro Colon is still under development. In a statement, Epigenomics said that it planned to submit a marketing application to the US Food and Drug Administration in 2011.
This week, Achim Plum, Epigenomics' vice president for corporate development, told PCR Insider that the company could not be more specific about an approval timeline at this point because it is just preparing for pre-submittal meetings with the FDA, which will help flesh out further requirements for submitting Epi proColon for approval.
NextPharma will manufacture Epi proColon test kits for both Europe and the US at its facility in San Diego. NextPharma serves small to large corporations worldwide in the biotech, pharmaceutical, diagnostic, and medical device industries. Its San Diego facility is FDA licensed for pharmaceutical and medical device manufacturing and is ISO 13485 certified for medical device manufacturing, Epigenomics said.
"They are fully cGMP compliant, which is not so much a requirement for the product in Europe, but it makes sense to concentrate the manufacturing at one site, and to have economy of scale," Plum said.
NextPharma's medical device capabilities include in vitro diagnostic reagents and kit preparation, custom procedure pack preparation; as well as research analytical reagents and research reagent kit preparation. NextPharma can also perform prototype and pilot manufacturing of Class I/II medical devices, Epigenomics said.
Epi proColon is based on the finding that DNA from the Septin9 gene is methylated in a vast majority of colon and rectal tumors, but not in normal cells. As tumor cells shed methylated Septin9 DNA into the bloodstream, the test can be used to detect and amplify it from patient plasma samples.
Assuming Epigenomics is able to successfully navigate the FDA approval process for Epi proColon, NextPharma will be "ideally positioned to manufacture our future product in the US," Uwe Staub, Epigenomics' senior vice president of product development, said in a statement.
Epigenomics has been pursuing a dual commercialization strategy for the Spetin9 biomarker: licensing it out to various companies to incorporate into their own colon cancer screening tests; and in the meantime developing its own commercial test.
In December, Epigenomics inked a deal with Abbott to develop and market a blood test based on Septin9 methylation in European and Asian/Pacific markets. As such, Epigenomics and Abbott optimized the test for Abbott’s RealTime system m2000, and it is now sold by Abbott as the RealTime mS9 Colorectal Cancer Assay.
Epigenomics has also licensed the Septin9 biomarker to Quest Diagnostics, which in January began offering in the US a laboratory-developed blood test for aiding in the detection of colorectal cancer; to ARUP Laboratories, which in July launched a similar lab-developed blood test (PCR Insider, 7/22/10); and to Canada's Warnex Laboratories, which is currently working on a laboratory-developed test using the biomarker (PCR Insider, 5/6/2010).
As for its own test, the deal with NextPharm is expected to help Epigenomics meet growing demand in Europe for Epi proColon, the company said. Although Plum said it was too early to completely quantify demand for the test, claiming that the company would need "a couple more quarters" of sales to provide specific numbers, he added that it had become clear that Epigenomics "will come to the end of our in-house manufacturing capabilities very soon."
One potential reason for growing demand in Europe: Epigenomics' April distribution deal with German clinical laboratory network Synlab, which is helping to expand distribution of the test in Europe (PCR Insider, 4/8/10).
As part of that deal, Epigenomics optimized Epi proColon for use on Life Technologies' Applied Biosystems 7500 Fast Real-Time PCR system, which Plum said is Synlab's testing platform of choice. The test was originally designed to be run on Roche's LightCycler 480 instrument; and has also been optimized for Abbott’s RealTime system m2000.
Plum said that Epigenomics has "a very specific idea" about which real-time PCR platform to pair with Epi proColon to seek US regulatory approval, but that it is still in talks with a candidate instrument manufacturer and thus could not disclose any more details.