Validation of a Lung Cancer Plasma Reflex Test Using Epigenetic Biomarker for Cancer Detection

Projektinformationen

proLungPlasma

ID Finanzhilfevereinbarung: 672680

DOI 10.3030/672680

Abgeschlossenes Projekt

EK-Unterschriftsdatum 2 Juni 2015

Startdatum 1 Juli 2015

Enddatum 31 Dezember 2017

Finanziert unter

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Gesamtkosten € 2 772 527,50

EU-Beitrag € 2 772 527,50

Koordiniert durch

EPIGENOMICS AG
Germany

Ziel

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.

Wissenschaftliches Gebiet

• engineering and technology › medical engineering › medical laboratory technology › laboratory samples analysis

Programm/Programme

• H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme
• H2020-EU.3.1.3. - Treating and managing disease

Thema/Themen

• PHC-12-2014 - Clinical research for the validation of biomarkers and/or diagnostic medical devices

Aufforderung zur Vorschlagseinreichung

H2020-SMEInst-2014-2015

Andere Projekte für diesen Aufruf anzeigen

Unterauftrag

H2020-SMEINST-2-2014

Finanzierungsplan

SME-2 - SME instrument phase 2

Koordinator

EPIGENOMICS AG

• Netto-EU-Beitrag: € 2 772 527,50
• Adresse: KLEINE PRAESIDENTENSTR 1 ; 10178 Berlin ; Deutschland
• KMU Die Organisation definierte sich zum Zeitpunkt der Unterzeichnung der Finanzhilfevereinbarung selbst als KMU (Kleine und mittlere Unternehmen). Ja:
  Region
  Berlin › Berlin › Berlin
• Region: Berlin › Berlin › Berlin
• Aktivitätstyp: Private for-profit entities (excluding Higher or Secondary Education Establishments)
• Gesamtkosten: € 2 772 527,50