We will develop a Class C (In-Vitro Diagnostic Regulation) medical device consisting of:
- a turnkey low-cost broadband Coherent Raman Scattering microscope (enabled by our patented graphene-based fiber laser technology)
- an Artificial Intelligence module based on deep learning, statistics and machine learning.
The instrument will offer to histopathologists a reliable, fast and low-cost Clinical Decision Support System for cancer diagnosis and personalized cancer therapy.
The CHARM technology will be capable of automatically analyzing unstained tissues, providing fast and accurate tumour identification (differentiating normal vs neoplastic tissues) with accuracy >98% and final tumour diagnosis prediction (differentiating and grading histologic subtypes) with accuracy >90%, thus offering to the histopathologist a decision tree compatible with existing clinical protocols but with biomolecular-based objectivity and reduced time to result (TRL6).
CHARM concept: an unstained sample is taken from the patient biopsy, its molecular fingerprint is analysed via Coherent Raman Scattering microscopy and elaborated by an Artificial Intelligence agent capable of highly accurate diagnosis, offering the histopathologist a visual support tool for decision making with human in the loop. The histopathologist remains the sole decision maker and the AI process is made fully transparent.