Performance Study with the SiMoT System for in Vitro Diagnostic Tests

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. Among the pathologies that will increasingly be monitored and treated thanks to enabling technologies for precision medicine, tumors are certainly of particular importance. 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. The SiMoT device is an in vitro diagnostic - IVD system (REGULATION (EU) 2017/746, IVDR Art. 2, point 2) that performs decentralized analyses (near-patient testing, such as, for example, patient's home, emergency unit, ambulance) composed of a palm reader completed by machine-learning / artificial-intelligence software. The system works through an accessory (IVDR Art. 2, point 4) represented by a disposable cartridge, which determines the specific diagnostic application based on the molecular markers detected by the accessory. 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.

The present performance study aims to verify the qualitative detection (on/off) of target molecules (both proteins and nucleic acids) with a single molecule threshold in 0.1 mL (10^-20 M). The threshold is established by the limit of identification (LOI).

Analytical performance will be evaluated according to standard statistical approaches such as: analytical sensitivity, analytical specificity, trueness (bias), precision (repeatability and reproducibility), accuracy (resulting from trueness and precision), limits of detection and identification, measurement range, possible linearity, threshold values, including the determination of appropriate criteria for the collection and handling of samples and the control of known endogenous and exogenous interferences, cross reactions.

Risk evaluation (Risk-to-Benefits rationale) There are no identifiable physical, psychic and/or social risks for the patients enrolled in the study directly deriving from the procedures that will be followed for the enrollment and collection of the related data.