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H2020

Colodetect Report Summary

Project ID: 666540

Periodic Reporting for period 1 - Colodetect (Development of a novel blood-based diagnostic test for colorectal cancer)

Reporting period: 2015-10-01 to 2016-09-30

Summary of the context and overall objectives of the project

A recent colorectal cancer (CRC) epidemiology report demonstrated a significant CRC burden in European countries, which is still associated with very high mortality rates. The overall objective of this project is the development and commercialization of a test for the early detection of CRC based on the detection and measurement of cancer-specific autoantibodies present in blood of patients. This test will detect simultaneously specific autoantibodies (biomarkers) against a reduced number of tumor antigens (8-10 in serum/plasma samples from CRC patients. To reach this objective, several technological challenges have to be overcome. One of of these challenges is the improvement of the sensitivity and detection limit in the early stages of CRC which will allow to surpass the obvious limitations of the invasive detection techniques extensively used, as the colonoscopy, and will offer additional advantages compared to traditional CRC diagnostic methods, such the simplicity in applications, detection, accuracy and a reduced cost. The expected outcome of this project will be a non-invasive CRC diagnostic kit, a high profit product, easy to use in screening of large populations at risk, low cost compared with high complexity tools competing technologies (colonoscopy/sigmoidoscopy), with good detection capacity at early stages, which will involve better treatment options to improve patient’s survival.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

During this first period (year-1) of the project implementation, the definition of the clinical trial for the future validation of the kit in development and the recruitment of patient’s serum/plasma samples were performed. As result of all abovementioned activities carried out during year 1 of the project, ProAlt has recruited and collected 2.288 serum and plasma samples (CRC patients, healthy donors and pathological –tumoral and non-tumoral- controls). Additionally, 746 samples from the collection of the collaborator CIB were also available during this period of the project, making a global number of 3.034 samples. For the study by ELISA of a selected group of serum/plasma samples from patients (validation cohort), 14 recombinant proteins (CRC antigens and control proteins) were produced, purified and well characterized. The ELISA protocol was also optimized and defined during this period. ELISA test plates were manufactured for each individual CRC antigen and plates were used to analyze 576 patients’ samples (validation cohort: CRC patients vs. ‘healthy’ donors). A total of 16.128 tests were performed in the period (12 ELISA plates per antigen; duplicates; 14 different CRC antigens studied). Post-coating antigen stabilization treatments conditions and studies were also performed (192 ELISA assays) during this period. Associated statistical analysis were performed. With regards with prototype optimization, a multiplex immunoassay for CRC diagnosis based on multiplex platforms were optimized using Luminex technology (low-density liquid arrays) for the conversion of the ELISA singleplex assay into a multiplex assay (capable to measure several biomarkers simultaneously in the same sample). Activities developed in Business and exploitation plan were focused in the extension of the intellectual property covering COLODETECT project was performed (Italy, France, Spain, Ireland, Poland, Switzerland, Netherland, Germany and United Kingdom; Europe, Australia, Canada and US). Finally, activities of dissemination and communication were focused to promote and exploit the results of the project by attendance to international and national leading trade fairs in biotechnological sectors, bilateral meetings with potential partners, clients and investors, participation in business forums, and design of specific webpage and graphic materials.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The outcome of this project will be a non-invasive CRC diagnostic kit, a high profit type of product, easy to use for screening of large populations at risk, low cost compared with high complexity tools competing technologies (colonoscopy/sigmoidoscopy), achieving good detection capacity at early stages, which will involve better treatment options to improve patient’s survival. During this period we have transformed the ELISA singleplex assay into a multiplex assay, capable to measure several biomarkers simultaneously in the same sample. Multiplex assay is also faster and more amenable to automation and more frugal with reagents than individual single-plex assays—which translates into cost savings.
COLODETECT is the first diagnostic test based on the novel auto-immunity strategy applied to cancer early diagnosis, a strategic and high impact area of the human healthcare system worldwide, being the early identification of CRC the main therapeutic area where the company expect to become a reference company during next years. Additionally the company will increase significantly its personnel in all business areas, consolidating the R&D department and increasing the investments in current and future research projects following the same auto-antibodies strategy, the competitive advantage of the company compared with competitors working in the same field. Other benefits will be the creation of a complete management structure within the company, including manufacturing, quality control, customer service, technical assistance, sales, marketing, business development, intellectual property, accounting, financial and administrative departments, employing qualified professionals according to the specific areas. The result will be the transformation of ProAlt in a big reference company within Europe.

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