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Developing a Non-Invasive Kit for Early Colorectal Cancer Detection

Periodic Reporting for period 2 - ColoFast (Developing a Non-Invasive Kit for Early Colorectal Cancer Detection)

Reporting period: 2018-11-01 to 2020-02-29

Colorectal cancer (CRC) is one of the most important health problems worldwide. 471,000 new cases were diagnosed in Europe in 2016 year and almost half of them died of this disease. The medical community agrees that this number of lives lost could be prevented by adequate screening programs. Decreasing the CRC mortality rate in Europe is a clear unmet medical need. Screening tests help to find premalignant lesions (i.e. Advanced Adenomas - AA) or CRC. Finding and removing premalignant lesions through a colonoscopy prevents CRC, whereas detection of early stage CRC improves patient prognosis.
The main objective of this project is to validate and commercialize a novel, non-invasive, simple to use kit (ColoFast™), for the diagnosis of colorectal cancer (CRC) in blood. It is based on a new generation of leading-edge biomarkers that showed very high sensitivity and specificity for early detection of CRC in two prospective cohorts. The commercialization of the kit will have clear impact in improving survival of patients and reducing mortality by CRC cancer, with significant cost savings for National Health Services. It will be easily implemented in the clinical routine of the majority of European hospitals, with better acceptance of patients.

From the scientific point, the main aim is to validate a signature of miRNA as biomarkers able to distinguish healthy subjects from those with premalignant lesions called Advanced Adenomas (AA) or with colorectal cancer (CRC). To achieve this aim, an important part of the project is focused in running a clinical trial including up to 3.100 participants that will be tested for miRNAs expression in order to obtain the best sensitivity and specificity in a blood-based test able to reach high compliance with colorectal cancer screening programs. In addition, and with final comparison purposes, other biomarkers such as CEA or analytical test (fecal immunochemistry test-FIT) will be performed in the same samples. Colonoscopy results will be obtained in all cases and will be use as the reference information for diagnostic purposes.
The main results achieved until now are mostly related to:
- Protocol definition: to design right operations for the validation of the kit (IVD) and the service (LDT), with patients meeting inclusion criteria, and accurate protocols for the technical steps. This results is allowing the proper execution of the multicenter prospective study necessary for the analytical validation. It has included the following activities: definition of inclusion and exclusion criteria for samples, definition of the protocols for sample collection, transport, storage and molecular analysis and database generation for clinical data collection.
- Patient enrolment and achievement of first results from clinical trial in Poland and Germany. The final aim of the clinical trial is to provide evidence of clinical validity- appropriate sensitivity and specificity of the test. The results obtained in this study are one of the key steps to allow ColoFast to reach the market. Until now patients have been recruited, each participant undertakes three different examinations: FIT test (faecal collection at home), colonoscopy (at the clinic with the standard procedure) and ColoFast (blood draw, 10 ml at the clinic). Samples will define diagnosis of healthy/AA/CRC and results will be compared to colonoscopy results as confirmatory diagnostic procedure
- Database generation and clinical data collection: During these period, data from patients (including dropouts, losses, and deviations) have been introduced in the eCRF, and also additional information regarding FIT and CEA analysis have been introduced in the database. Central lab data base generation has also been accomplished, with compliance of security requirements. A data transfer plan has been set in place.
- Prototype design: Extensive work has been done to increase robustness of the clinical signature, including additional biomarkers analysis in order to reach a high performance of Colofast in the clinical setting. Technical aspects have been extensively addressed in order to improve the prototype design and scale up.
- Validation of the kit taking into account the European standards: The company has developed all the required documentation to comply with directives and regulatory rules that relates to the kit design. AMADIX developed a comprehensive analytical validation of ColoFast test with the aim of validating the experimental procedures and apply it as a LDT for the analysis of the clinical samples collected
- Development of a web-based software by which the potential users of ColoFast will have the opportunity to load the technical results, obtaining in a very short period of time, the unitary clinical results for each studied sample.
ColoFast is highly novel because it is based on a signature of miRNA as a new generation of cutting-edge biomarkers in plasma for CRC diagnosis in less than 4 hours. There is no test in the market based on miRNAs as of today. Colofast shows a higher sensitivity in the detection of AA in average risk subjects undertaking screening, better acceptance and higher compliance in the screening population with a simple blood analysis. The pharmaco-economic analysis of ColoFast showed the cost-effectiveness of using the test in different scenarios. Moreover, ColoFast will have an impact in decreasing CRC mortality as a consequence of identifying and treating patients at earlier stages of the disease, improving the clinical yield of the program and reducing the number of unnecessary colonoscopies. Besides the introduction of ColoFast would reduce the global expenses in the screening program implementation, and would increase the acceptance rate of the screening by switching to a blood based test.
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