Performance Study with the SiMoT System for in Vitro Diagnostic Tests

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Non-interventional Analytical Performance Study on Left-over Samples
• Intervention / Treatment: Diagnostic test: analytical performance study

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

• Italy
  • Bari, Italy, 70124
    • IRCCS Istituto Tumori Giovanni Paolo II, Gynecological Oncologic Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study involves around 50 patients with solid tumors who will come to the Gynecological Oncologic Clinic at IRCCS Giovanni Paolo II Cancer Institute and who are prescribed for pre-hospitalization procedures as per standard clinical practice at the investigational site.

Description

Inclusion Criteria:

• Informed Consent and personal data handling consent signed by the subject;
• > 18 years of age
• presence of neoplastic or suspected neoplastic pathology at the time of sample collection

Exclusion Criteria:

• < 18 years of age
• Participation in a clinical trial with an investigational drug or a medical device within the 30 days preceding and during the present investigation.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Open; Test analysis perfomed in open to train the artificial intelligence algorithm.	Diagnostic test: analytical performance study; analytical performance study on left-over samples with the SiMoT IVD system for in vitro diagnostic tests
Blind; Test analysis performed in blind to minimize biases when evaluating the predictive performance of the IVD under investigation.	Diagnostic test: analytical performance study; analytical performance study on left-over samples with the SiMoT IVD system for in vitro diagnostic tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the analytical performance in plasma, serum, and urine samples supplemented with non-endogenous molecules (three proteins and two nucleotide sequences) of the SiMoT handheld device	Qualitative detection of specific marker at single molecule level	December 2024

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of analytical analysis performance	To define the time to obtain the test result (time-to-result) for a complete analysis.	December 2024

Collaborators and Investigators

• Sponsor: Centro di Innovazione Regionale in Single Molecule Digital Assay

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2024
• Primary Completion (Actual): November 30, 2024
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: July 19, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: SiMoT-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No