During the whole project implementation period, two blood-based colorectal cancer detection tests were developed using two different affordable technologies, ELISA and Luminex. Both tests were clinically validated. For that purpose, a clinical trial was carefully designed and all associated procedures for recruitment of samples (serum/plasma) from selected patients’ were defined and implemented. By the end of the project, a total of 4,213 samples belonging to 3,339 patients has been collected. In all cases, sample-associated information was obtained and most critical information was harmonized in a database (DB) constructed by the company. Subcontractors made a great contribution to reach this ambitious milestone. Standard operation procedures (SOPs) were followed for sample collection and management. All samples incorporated to the study had the Patient’s informed consent and the approval of the Ethical and Scientific Committees of each Center. All biomarkers in study that were used in the different technological platforms of COLODETECT® project (ELISA and Luminex®) were continuously produced, improved and tested by their ability to bind the autoantibodies (AAbs) present in samples from a patients. Scale-up procedures were also implemented for the manufacturing of kits, and a quality control system was implemented under ISO13485 standards. ELISA-based studies initially involved 14 different antigens (lead antigens) and later another 10 antigens (antigens in back up). A pre-selected validation group of serum/plasma samples from patients (N=576; validation cohort: CRC patients vs. ‘healthy’ donors) was used for prototypes validation. ELISA plates were manufactured and used to analyze 576 patients’ samples. A total of 16,128 tests were performed in years-1 and -2. By the end of year-2, ProAlt started with the large-scale manufacturing of (i) the ELISA-based test and in parallel (ii) the multiplexed assay in Luminex®, both aimed for early detection of colorectal cancer in patient’s blood. During year-3, the company conducted the full clinical validation of the diagnostic tests developed (ELISA and Luminex) using a large number of patients’ blood samples from the collection constructed during the project (multicentric and diverse). The cohort assayed consisted of serum/plasma specimens from 1,361 selected CRC and ‘healthy’ individuals covering all tumoral stages. A great volume of data, up to 610,368 tests, was generated. The diagnostic capacity and performance of each antigen in study led to the establishment of an autoantibodies signature for each platform assayed. At the end of the project, two different diagnostic tests for CRC were developed: a multiplex test based on the Luminex platform and an ELISA singleplex test. The regulatory procedure for IVD (CE marking) obtaining was initiated as well. Complimentary and strategic activities were also developed as part of the business and exploitation plan, which were supported by the maintenance and extension of the intellectual property related to the use of autoantibodies as diagnostic tools. New patents were filled. COLODETECT® trademark registration was also performed. Competitors have been monitored systematically, and Technology Surveillance reports were generated twice a year. The commercialization strategy was continuously adapted to the product performance and limitations. Dissemination and communication activities were periodic and substantial,B ilateral meetings with potential partners and investors (Medica, BIO Convention, BioEurope Spring, Anglonordic, others), potential clients (Olympus, Roche Diagnostics, Johnson & Johnson, others) and personalized follow up presentation to investors who showed special interest. Meetings with CRC patient associations also were celebrated. A project webpage, graphic and visual materials were produced, among others.
