Predictive test for response to chemotherapy in colorectal cancer

Colorectal cancer (CRC) is a major public health problem with 1.2 million new cases diagnosed each year and approximately a half a million deaths worldwide. The survival is associated to the clinical staging of the primary tumour. Major efforts are dedica ted to precisely stratify the tumours that will or will not recur after surgery and to tailor the adjuvant treatment protocol for the individual patient. To improve clinical outcome there is a need for molecular markers that can outperform the histopatho logical staging in predicting the likelihood of disease recurrence following surgery. We have developed two gene-expression based prognostic tests, ColoGuideEx and ColoGuidePro, for stage II and stage III CRC patients. These are clinically validated in in dependent patient series across populations and they identify "the expected" percentages of patients with high risk of recurrence. We propose that this pre selection of high risk patients at time of diagnosis will ensure identification and establishment o f predictive tests with high precision for the CRC patient and cost efficient for the clinic. The predictive value of the markers of the ColoGuide tests will be determined, novel predictive signatures will be identified and companion diagnostic markers fo r targeted therapy among the patients with high risk of recurrence will be validated. The Cologuide-EX and -PRO for "high risk assessment" appear on the basis of current clinical validation to substantially outperform the marketed products, and the most likely option is to commercialize the two signatures together with the same industrial partner, as a package of "high risk assessment" and "predictive index". We expect the project to finalize in an agreement with an industrial partner for co-development and eventual licensing of the ColoGuide signatures for implementation in a molecular prognostic and predictive test to be deployed by the licensee to health care institutions.