Epigenomics AG and NEXT-pharmaceutical sign world-wide agreement over order production of intestine cancer blood test

The molecular diagnostics enterprise Epigenomics AG and NEXT-pharmaceutical Technologies, the prominent European offerers for production development, order production, cooling chain and logistics outsourcing for the pharmaceutical and biotechnological industry, communicated today that the enterprises signed a world-wide agreement for the order production of Epigenomics� product Epi proColon. Epi proColon is that world-wide first in-vitro-diagnostic test for the proof of colon cancer with the help of a simple blood test and by Epigenomics in Europe is at present driven out. The contract between the enterprises plans that NEXT-pharmaceutical Epigenomics� manufactures CE-characterized Epi proColon Testkit for Europe and other markets in accordance with the ISO 13485-Standard for Medzinprodukte. Besides NEXT-pharmaceutical is to manufacture the cGMP standard appropriate version of the test kit for the US-American market, which is developed at present by Epigenomics. Epigenomics plans to submit an application for admission for the Epi proColon test 2011bei of US FDA (Food and Drug administration). " With NEXT-pharmaceutical we found the ideal partner for the order production, which the rising demand for the Epi proColon Testkit in Europe cover kann" , Dr. Uwe explained dust, senior Vice President Product development with Epigenomics. " With its quality standards and the enormous experience in the production of medicine products NEXT-pharmaceutical is besides excellently set up, our future US product herzustellen." NEXT-pharmaceutical will manufacture the Epi proColon Testkit at their US location in California San Diego. This plant serves world-wide small and large enterprises in the biotechnological, pharmaceutical, diagnostic and medicine-technical industry. The aseptische range of this plant has several Reinraum Suiten with Klasse-10. 000 (class 7 or class C), formulation area and Klasse-100 (class 5 or class A) filling up hoods and/or - vacate. The plant is FDA certified for the production of pharmaceuticals and FDA as well as ISO 13485-zertifiziert for the production of medicine products. To NextPharmas authority within the range of medicine products belongs the production of in-vitro-diagnostic reagents and kits, custom-made packing solutions as well as the production of analytic agents and kits for applications of research. Further NEXT-pharmaceutical in the position is to manufacture prototypes and pilot series of medicine products of the classes I and II. " We are very much pleased, with Epigenomics with the production of this innovative diagnostic test for the early recognition of colon cancer for the world-wide market zusammenzuarbeiten" , Bill Wedlake, Chief Executive Officer explained of NEXT-pharmaceutical Technologies. " This is a certification of our K�nnens, our flexibility and speed in the case of the supply of this important product. Made possible this is " by the large experience of our team for medicine products combined with the use of our most modern technologies at our location in San Diego.; To overcome the Epi proColon Bluttest for colon cancer comfortably and patient-friendly conceived with the goal one of the largest hurdles for an effective early recognition: the acceptance lacking of the available procedures for the proof of colon cancer. For the Epi the patients let themselves proColon test be only decreased with its physician a blood test, e.g. in the context of a routine investigation. The blood test is then sent to molecular diagnostics a laboratory, where it is examined for methylierte DNA of the Septin9-Gens (mSEPT9). In several drop control studies with cancer patients and by Koloskopie examined intestine-cancer-free control pro gangs as well as in a prospektiven population-based study also over 7.900 test persons (" PRESEPT") it could be shown that the proof of mSEPT9 is in blood plasma a reliable reference to a cancer condition of the thick and final intestine. Offered procedures for the intestine cancer early recognition - under it the test on okkultes blood in the chair (FOBT) and the intestine reflection - are usually noticed as unpleasant or pedantically and too rarely used from there of persons at the age of 50 years and older, although these should participate regularly in preventive medical examinations. Therefore the majority of the cases of cancer is only diagnosed in advanced stages, in which the healing chances sank strongly. The Epi proColon Bluttest the chance, more humans saves that humans with colon cancer under these to the participation in the early recognition to induce and to let an early and thus more promising therapy become too part.

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