Clinical Research Directory

Performance Study with the SiMoT System for in Vitro Diagnostic Tests

Sponsor: Centro di Innovazione Regionale in Single Molecule Digital Assay

Summary

Advanced and performing technologies able to analyze specific biomarkers for the diagnosis, prognosis and prediction as well as for the monitoring, the personalized care and the evaluation of the therapeutic response to pathologies, is currently considered extremely relevant. Such technologies work only if molecular markers specific for a given pathology have been already validated. This approach is considered of strategic importance for the health and well-being of citizens as well as for the sustainability of public spending. Often, however, the analysis of the markers is carried out on tissues or fluids of the organs involved, being hence quite invasive procedures. In this scenario, it is strategic to develop devices and platforms that allow the analysis of markers in a minimally invasive or non-invasive way, through the analysis of peripheral biological fluids, such as blood or urine. The goal is to provide clinicians with the attacker's advantage against a plethora of progressive diseases by mass-screening individuals who are affected by a disease long before symptoms appear or to allow the identification of those patients who have a high probability of recurring or responding to target-oriented pharmacological approaches. This study pertains to the definition of the analytical performance of the Single-Sensor Single-Molecule with a large Transistor (SiMoT) device. In the context of the present performance study, the IVD SiMoT system will be equipped with an accessory-cartridge developed and produced without any diagnostic purpose but only to verify the analytical performance of the SiMoT system, in the detection of exogenous biochemical molecules suitably selected to act as markers of interest.

Official title: Analytical Performance Study of the Handheld Device Single-Molecule with a Large Transistor (SiMoT) for the Near-patient Testing of Biological Samples

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