Obiettivo The objective of “proLungPlasma” is the clinical validation of a lung cancer test, which detects DNA methylation of the specific biomarker mSHOX2. Methylation of DNA is an important epigenetic process involved in fundamental biological processes as development and cell differentiation. Aberrant DNA methylation plays a major role in cancer development. Epigenomics is very successfully engaged in epigenetic research since 1998 resulting in an outstanding proprietary platform for epigenetic biomarker discovery for cancer. Epigenomics is now market leader in epigenetic biomarker test kits detecting most frequently occurring forms of cancer as colorectal and lung cancer from different sample materials. Lung Cancer is the most deadly of all cancer diseases. Unfortunately, lung cancer screening by Low Dose Computer Tomography (LDCT) is burdened by unacceptably high false positive rates. The newly developed Epi proLung Plasma Reflex Assay is urgently required as a tool for reducing false positive rates. Therefore, the Epi proLung Plasma Reflex Assay is a highly anticipated pre-requisite for successful implementation of lung cancer screening in Europe. This business innovation project will validate the Epi proLung Plasma Reflex Assay for the diagnosis of lung cancer in plasma under the upcoming new IVD regulation. The validation process to be performed in this business innovation project will be used as a blueprint for the standardized validation of all further epigenetic biomarker blood tests. Epigenomics’ established test platform, its product development and regulatory expertise, and the standardized validation process are expected to kick-off further strong growth on major global MDx markets. Campo scientifico engineering and technologymedical engineeringmedical laboratory technologylaboratory samples analysis Programma(i) H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme H2020-EU.3.1.3. - Treating and managing disease Argomento(i) PHC-12-2014 - Clinical research for the validation of biomarkers and/or diagnostic medical devices Invito a presentare proposte H2020-SMEInst-2014-2015 Vedi altri progetti per questo bando Bando secondario H2020-SMEINST-2-2014 Meccanismo di finanziamento SME-2 - SME instrument phase 2 Coordinatore EPIGENOMICS AG Contribution nette de l'UE € 2 772 527,50 Indirizzo KLEINE PRAESIDENTENSTR 1 10178 Berlin Germania Mostra sulla mappa PMI L’organizzazione si è definita una PMI (piccola e media impresa) al momento della firma dell’accordo di sovvenzione. Sì Regione Berlin Berlin Berlin Tipo di attività Private for-profit entities (excluding Higher or Secondary Education Establishments) Collegamenti Contatta l’organizzazione Opens in new window Sito web Opens in new window Partecipazione a programmi di R&I dell'UE Opens in new window Rete di collaborazione HORIZON Opens in new window Costo totale € 2 772 527,50
