The technology is an ultra-sensitive optical biosensor based on the FRET principle, designed for identifying the initial, pre-aggregated pathological form of the Tau protein (CST). The innovation lies in the ability to detect specific conformational changes (CST), providing a molecular advantage over concentration-only tests.
In vitro validation (TRL 3) has been successfully completed, demonstrating the sensor's effectiveness on:
- Human brain lysates containing pathological Tau.
- Identification of responses to drugs and synthetic pathology inducers in cellular models.
The next phase (TRL 4) is the translation and verification of sensitivity in biological fluids (e.g., urine/saliva/serum/plasma/CSF) for diagnostic test development. Currently, the technology is already an advanced Drug Screening tool.
The competitive advantage is built on two fronts:
- Pharmaceutical Research (Drug Screening): The FRET CST sensor is a proven tool for drug discovery and screening, allowing for a rapid and quantitative real-time read-out of the efficacy of new molecules on pathological mechanisms in vitro.
- Future Diagnostics: The system offers the potential for non-invasive and low-cost screening (from urine/saliva/serum/plasma samples, once validated), overcoming the cost and invasiveness of current clinical diagnostics (PET/MRI, lumbar puncture).
- Early Detection: It detects Tau in its initial conformational form (CST), offering an earlier intervention window, which is crucial for new therapies.
- Sensitivity: The use of FRET ensures an extremely low limit of detection.
The technology is poised to transform the first-line diagnostics for Alzheimer's disease.