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.
