Colorectal cancer, Biomarker
Colorectal cancer (CRC) is the third most frequent type of cancer worldwide and incidence rates further increase. The recent implementation of CRC screening programs has reduced mortality rates, but it still is the third cause of cancer deaths worldwide. This high mortality results from the often late diagnosis, the current pitfall in CRC treatment. This problem is not overcome by the most frequently used diagnostic test, the faecal occult blood test (FOBT) that optimally detects CRC only in later stages (III and IV of four tumor stages). FOBTs furthermore lead to high false positive (> 5%) and false negative (> 9%) rates. We are currently validating a new, non-invasive CRC diagnostic test which is able to detect CRC in all stages with much lower false positive and false negative rates. Our high-throughput potent analysis makes this test very suitable for use in CRC screening programs. Early detection of CRC will significantly reduce CRC mortality rates.
Worldwide, 1.2 million people were diagnosed having CRC in 2008. More than one third of the new CRC cases are detected in the European Union (435.000 in 2010). Almost half the population diagnosed with CRC dies from the disease (609.000 worldwide, 2008; 215.000 EU, 2010). These numbers convinced the European Union and the US to advice the implementation of CRC screening programs for the population aged 50-74 years in their members/states. In Belgium more than 3 million people, and in the entire European Union 140 million people, are in the recommended age range for screening.
Our new CRC diagnostic test combines state-of-the-art technology with a unique method for biomarker identification (patent application filed). Moreover, it focuses on a broad (in contrast to existing tests) panel of CRC biomarkers resulting in high sensitivity and specificity percentages, and thus low false negative and false positive rates when compared to FOBTs and other non-invasive tests. In addition, the test allows for CRC diagnosis in the early, most curable stages and for the monitoring of cancer regression and recurrence. Further advantages are the high-throughput potential and the non-invasive, thus patient-friendly, nature of the tissue sampling method, making it an ideal diagnostic test for large screening programs. In addition, the developed method is suitable for the detection of other types of disease-related biomarkers, e.g. for breast cancer.
For the valorization of our unique diagnostic method, we will initially focus on the start-up of a CRC diagnostic service spin-off company. We will offer highly sensitive and specific CRC diagnosis covering all stages as a service, and we will expand our service later on to CRC staging and monitoring of CRC regression and recurrence. Application of the new diagnostic method can furthermore be extended to biomarker discovery for all existing cancer types as well as all imaginable diseases that lead to altered biomarker panel profiles in the tissues under examination.
We recently filed a patent application for our unique biomarker discovery method. At this moment, we started with the validation of selected CRC biomarkers in order to further optimize the biomarker panel for the new CRC diagnostic test. We collaborate with prof. Eric Van Cutsem, a key opinion leader in the field of colorectal cancer. In addition, negotiations for obtaining exclusive licenses with patent owners of interesting CRC biomarkers are ongoing.
The most important upcoming milestones are: - (1) Finishing the validation of CRC biomarkers - (2) Verification of the selected CRC specific biomarker panel (‘clinical study’) The ongoing validation and subsequent verification of the CRC biomarkers demands a substantial financial input: - consumables, waste removal (hazardous biological waste), costs for using the available equipment, new state-of-the-art MS equipment, scientific (two post-docs) and technical (one lab technician) personnel - IT requirements: data storage space and software licenses for data storage and analysis - patent application for the selected CRC specific biomarker profile