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.