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Reliable, non-invasive devices
Having enabling technologies for the diagnosis and monitoring of diseases for which specific molecular markers have been validated is considered of strategic importance both for the health and well-being of citizens and for the rationalization of public spending. However, marker analysis is often performed on tissues or fluids of the organs involved, thus being too invasive. In this scenario, it is recognized to be of great importance to devise and develop devices and platforms that allow marker analysis in a minimally invasive way, through analysis in peripheral biological fluids.
The aim of the Regional Innovation Center “Single-Molecule Digital Assay” is to develop Point of Care (POC) enabling technologies with very high performance (single-molecule detection limit, false-positive and false-negative less than’ 1-5 %) capable of detecting both molecular markers (DNA, RNA) as well as proteins/antigens, can thus provide clinicians with the attacker’s advantage against a plethora of progressive diseases, being able to isolate in a mass screening those individuals who are definitely affected by a progressive disease long before symptoms become apparent.
Point of Care technologies
Diagnosis sent directly to the patient
The development of ultra-high-performance POC enabling technologies would also enable the control of infectious diseases by countering their spread. Digital biomedical devices would also enable the transfer of analysis data directly to a data base (cloud) to which health care personnel could have direct and fast access. In an optimized system, the analysis response with the possible diagnosis could, therefore, be sent directly to the patient.
Therefore, the following objectives will be realized within the scope of this project:
- Develop both the handheld measurement and reading device and the disposable and recyclable cartridge by taking them from the current Technology Readiness Level (TRL) 4-5 (validated technology in laboratory/relevant environment) to TRL 7 (demonstration of a prototype system in an operational environment), where operational environment means not only in a hospital setting but also at the doctor’s office, pharmacy or directly at the patient’s home.
- Perform 1500 analyses (clinical trial) whose results should verify single-molecule limits of detectability, high reliability, i.e., false-positives and false-negatives less than 1 – 5 %, time required to complete the test less than one hour, operate directly on the sample the blood or saliva of a patient.