CRC BIOSCREEN 3.0
Colorectal cancer (CRC) is the third most common cancer worldwide. Disease symptoms typically arise at a late stage, requiring substantial clinical intervention while reducing overall cure rate to about 50%. Therefore, CRC screening for detecting early disease is the best option to reduce high CRC mortality, as well as to reduce morbidity associated with cancer treatment.
The straightforward solution of this project improves current FIT testing by using a combination of protein biomarkers. The consortium has demonstrated improvement of current FIT by detecting additional protein biomarkers in stool, by developing reliable immunoassays for these markers, and validating in a retrospective series of 1284 FIT samples. As they are using a multi-target approach by combining complementary biomarkers, they refer to the test as the multiFIT.
The multiFIT is estimated to have a 60% higher sensitivity for detection of advanced adenomas relative to the current FIT (i.e. 45.2% versus 28.1%, respectively). Improving detection of these advanced adenomas translates directly into reduced CRC incidence and mortality. Because these biomarkers are proteins that can be detected in the same minimal stool samples as the ones used in FIT based screening, the multiFIT would be compatible with logistics of current FIT based screenings programs. Moreover, the test can be cost effective compared to FIT. The consortium therefore is convinced that the multiFIT can become a second-generation stool-based screening test most broadly used for CRC population screening in Europe, Asia, Australia and other regions worldwide.
Previously, the consortium developed a feasibility lot of the biomarker assay. In this project, a verification assay lot weas developed and tested on its performance, by assessing reproducibility in assay calibration and in sample quantitation. This effort has resulted in two immunoassays that fulfil the required quality standards and that are ready to be used for a prospective screening trial. In this trial the consortium aims to show the additional value of the multiFIT next to the regularly used FIT. Moreover, they obtained ethical (WBO) approval for this prospective screening trial. Currently we are working of the preparations for this screening trial.
