The main objective of this project is to obtain a colorectal cancer diagnostic kit clinically validated and regulatory approved as an in vitro diagnostic product (IVD), and as well, to penetrate in the CRC diagnostic market allowing PROALT to reach a competitive position by improving its competitiveness.
COLODETECT will detect simultaneously the presence in serum/plasma samples from CRC patients of specific autoantibodies (biomarkers) against a reduced number of tumor antigens (8-10).
The assay for the detection of CRC will be established and validated with clinical samples and tested for their marketability, to finally overtake the regulatory process to obtain the CE marking.
To reach this objective, several technological challenges have to be overcome, like to improve the sensitivity and detection limit in the early stages of CRC avoiding the obvious limitations provided by the invasive detection techniques extensively used, as the colonoscopy, and offering additional advantages compared to traditional CRC diagnostic methods, such as the simplicity in applications, detection, accuracy and reduced cost.
The results obtained in this project will have extensive impact and benefits for European population at risk, since early detection programs are essential to decrease mortality around 30-35% and drastically reduce the treatment costs of people affected by the pathology, assuring the sustainability of the European healthcare systems and others in the world.