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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - PATHOLYTIX-GI (PATHOLYTIX: Using Artificial Intelligence to Transform Clinical Diagnostic Pathology)

Teaser

Summary

Routine diagnosis on biopsies and tissues is performed by expert pathologists reviewing the tissues down a microscope. One of the largest sub-specialties is gastrointestinal pathology, which processes biopsies taken during from endoscopy and colonoscopy procedures. However, pathology services faces a major crises, due to soaring numbers of biopsies for diagnosis, coupled with decreasing numbers of trained pathologists, which is causing delays and affecting patients. New technology can alleviate this crises by using computer aided diagnosis (CAD) to increase productivity, reduce costs and streamline workflow.

Deciphex Ltd is an Irish company developing an innovative Computer Aided Diagnosis (CAD) system which will revolutionize the medical diagnosis pathology sector. Our â€˜PATHOLYTIXâ€™ system uses state-of-the-art artificial intelligence techniques to automate the laborious and costly pathology assessment. In this feasibility study we demonstrated the technical viability, commercial and economic viability of our system, while also gaining some essential insight into the user needs and market dynamics.

This feasibility study included the following activities:
1. Technical Feasibility and pilot studies on Gastro-Intestinal biopsies.
2. IP and Regulatory review
3. Market analysis and Business plan

Work performed

During this project Deciphex completed all elements of the work, with the following insights:

Technical feasibility:
We performed a proof of concept studies on 365 colon samples, including varying grades of adenoma, colitis and carcinoma. The system was able to differentiate the disease states from the normal tissue, providing a colour coded overlay image indicating the areas of disease and numerical outputs. Overall the system performed well, indicating the technical viability of the system.

IP and Regulatory review:
Firstly we reviewed the competitive and IP landscape to determine freedom to operate for the company. Deciphex also filed two patent applications to protect the methodology, which we will augment as the system is developed. We also reviewed the EU and US regulations that govern our product, creating an implementation and validation strategy.

Market Analysis and Business plan:
During the feasibility study we also performed a comprehensive market and user analysis study. It identified a large market that is growing due to increasing population and increasing number of surgical procedures. The study also confirmed the current clinical need for a CADX system and a gap in the market. There is also a very competitive landscape with large players and new start-ups developing AI technology. However, our assessment indicated there are several points of differentiation between Deciphex and other competitors developing CADX systems. From these insights we have created a comprehensive business plan to develop the product forward.

Final results

Overall the outcome of Phase 1 is positive, showing technical, commercial and financial viability of the CADX system. We have gained better insight into the users needs and market dynamics, and the uniqueness of our approach. Overall, PATHOLYTIX would have a big impact on the pathology sector, by increasing productivity and reducing costs. This should have a knock on effect for the global and EU markets, particularly for patients as diagnosis becomes more efficient.