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Photo: Jarle Bruun

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

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Photo: Jarle Bruun

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

  2. Early diagnosis will improve patient survival Illustration is modified from National Cancer Institute

  3. SURVIVAL 5 years 90% 81% 63% 9% Illustration is modified from National Cancer Institute Survivial: data from the Norwegian Cancer Registry, 2009 Early diagnosis will improve patient survival

  4. Diagnostics 5-35 years ”Window of opportunity” for diagnostics Normal mucosa Small adenoma Intermed. adenoma Large adenoma Carcinoma

  5. Fecal DNA test Limited sensitivity and specificity -The ColoSure test. Methylation marker, VIM Blood/plasma/serum test -Epi ProColon test. Methylation marker, SEPT9. Need for additional tests/biomarkers • FOBT = fecal occult blood test • Well established, simple, reduce mortality of CRC • Unspecific, limited sensitivity, and limited detection of precursors (adenomas)

  6. Results Innovation/development • New strategy for identification of methylated candidates • Lind et al Cell. Oncol. 2006 • DOFI signed, patent application • 2007 • Proof-of-principle • Lind et al Gastroenterology 2007 • Clinical validation of first biomarker • Lind et al J Transl Med. 2008 • PCT/EP2008 • PA published, WO 2008/102002 • 2008 • Methylation in precursor lesions • Ahlquist et al Mol Cancer. 2008 R&D, TTO Biotech conferences 2009 MTA phase I-II signed Eur Biotech comp 2010 • Panel of biomarkers published • Lind et al Mol Cancer. 2011 • Analysis of biological function • Lind et al Oncogene. 2011 License agreement? 2011 Project progress and time frame Experimental pipeline Six biomarkers identified

  7. Normal Benign Malignant Test N = 51 N = 61 N = 80 Validation N = 59 N = 52 N = 105 Clinical test and validation series Normal mucosa Small adenoma Intermed. adenoma Large adenoma Carcinoma

  8. 93%94% Sensitivity Adenoma (n=111) Carcinoma (n=179) Spesificity Normal mucosa n=110 98% Biomarker performance

  9. ROC confirms high sensitivity and specificty

  10. Normal Benign Malignant N = 72 N = 30 N = 30 Carcinomas Fecal samples Blood samples Normal mucosa Fecal samples Blood samples Adenomas Fecal samples Blood samples ”Clinical proof of concept”: Non-invasive testing using fecal samples NordICC screening

  11. Cancer Registry • Dr. Michael Bretthauer • Prof. Geir Hoff www.rr-research.no/cancerprevention Collaborators • Department of Cancer Prevention • Prof. Ragnhild A. Lothe • Group leader and head of Department • Stine A. Danielsen • Hilde Honne • Oslo University Hospital • Prof Arild Nesbakken • Dr. Espen Thiis-Evensen • Prof. Torleiv O. Rognum

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