Oslo University Hospital Department of Cancer Prevention Institute for Cancer Research Radiumhospitalet Centre for Cancer Biomedicine Photo: Jarle Bruun.

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Presentation transcript:

Oslo University Hospital Department of Cancer Prevention Institute for Cancer Research Radiumhospitalet Centre for Cancer Biomedicine Photo: Jarle Bruun Guro E. Lind Department of Cancer Prevention Ragnhild A. Lothe group Cancer Biomedicine University of Oslo Biomarkers for non-invasive testing for colorectal cancer Photo: Jarle Bruun ”Life sciences for health and innovation” Oct 11th 2011, Oslo

Oslo University Hospital Department of Cancer Prevention Institute for Cancer Research Radiumhospitalet Centre for Cancer Biomedicine Early diagnosis will improve patient survival Illustration is modified from National Cancer Institute

Oslo University Hospital Department of Cancer Prevention Institute for Cancer Research Radiumhospitalet Centre for Cancer Biomedicine Early diagnosis will improve patient survival Illustration is modified from National Cancer Institute 90% 81% 63% 9% Survivial: data from the Norwegian Cancer Registry, 2009 SURVIVAL 5 years

Oslo University Hospital Department of Cancer Prevention Institute for Cancer Research Radiumhospitalet Centre for Cancer Biomedicine ”Window of opportunity” for diagnostics Normal mucosa Carcinoma Intermed. adenoma Small adenoma Large adenoma Diagnostics 5-35 years

Oslo University Hospital Department of Cancer Prevention Institute for Cancer Research Radiumhospitalet Centre for Cancer Biomedicine FOBT = fecal occult blood test Well established, simple, reduce mortality of CRC Unspecific, limited sensitivity, and limited detection of precursors (adenomas) Blood/plasma/serum test -Epi ProColon test. Methylation marker, SEPT9. Fecal DNA test Limited sensitivity and specificity -The ColoSure test. Methylation marker, VIM Need for additional tests/biomarkers

Oslo University Hospital Department of Cancer Prevention Institute for Cancer Research Radiumhospitalet Centre for Cancer Biomedicine Project progress and time frame Experimental pipeline Results New strategy for identification of methylated candidates Lind et al Cell. Oncol Proof-of-principle Lind et al Gastroenterology 2007 Clinical validation of first biomarker Lind et al J Transl Med Methylation in precursor lesions Ahlquist et al Mol Cancer Panel of biomarkers published Lind et al Mol Cancer Analysis of biological function Lind et al Oncogene Innovation/development DOFI signed, patent application 2007 PCT/EP2008 PA published, WO 2008/ R&D, TTO Biotech conferences 2009 MTA phase I-II signed Eur Biotech comp 2010 License agreement? 2011 Six biomarkers identified

Oslo University Hospital Department of Cancer Prevention Institute for Cancer Research Radiumhospitalet Centre for Cancer Biomedicine Clinical test and validation series Normal mucosa Carcinoma Intermed. adenoma Small adenoma Large adenoma N = 61 NormalBenign N = 51 Malignant N = 80 Test N = 59N = 105N = 52 Validation

Oslo University Hospital Department of Cancer Prevention Institute for Cancer Research Radiumhospitalet Centre for Cancer Biomedicine Biomarker performance Sensitivity Adenoma (n=111) Carcinoma (n=179) Spesificity Normal mucosa n=110 93% 94% 98%

Oslo University Hospital Department of Cancer Prevention Institute for Cancer Research Radiumhospitalet Centre for Cancer Biomedicine ROC confirms high sensitivity and specificty

Oslo University Hospital Department of Cancer Prevention Institute for Cancer Research Radiumhospitalet Centre for Cancer Biomedicine ”Clinical proof of concept”: Non-invasive testing using fecal samples Malignant N = 72 Carcinomas Fecal samples Blood samples Benign N = 30 Adenomas Fecal samples Blood samples N = 30 Normal mucosa Fecal samples Blood samples Normal NordICC screening

Oslo University Hospital Department of Cancer Prevention Institute for Cancer Research Radiumhospitalet Centre for Cancer Biomedicine Collaborators Cancer Registry Dr. Michael Bretthauer Prof. Geir Hoff Oslo University Hospital Prof Arild Nesbakken Dr. Espen Thiis-Evensen Prof. Torleiv O. Rognum Department of Cancer Prevention Prof. Ragnhild A. Lothe Group leader and head of Department Stine A. Danielsen Hilde Honne