Developing a Non-Invasive Kit for Early Colorectal Cancer Detection

With 1.93M new cases diagnosese in 2020 and 48% mortality rate (Globocan 2020) colorectal cancer (CRC) is the second leading cause of cancer-related deaths worldwide. Most of these cancers and deaths could have been prevented by increasing the use of recommended screening tests, which can detect premalignant lesions, called advanced adenomas (AA) in the colon and rectum. 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 test (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 test 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 and additional biomarkers 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 biomarkers 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 used 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 3.361 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.
- Analitycal and Clinical validation taking into account the European standards: 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 test performance. 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 24 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.

Periodic Reporting for period 3 - ColoFast (Developing a Non-Invasive Kit for Early Colorectal Cancer Detection)

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