Periodic Reporting for period 1 - IBDetect (Point of Care Diagnostic Test for the Differential Diagnosis of Inflammatory Bowel Disease)
Periodo di rendicontazione: 2019-12-01 al 2020-05-31
Inflammatory bowel disease (IBD) is a chronic inflammation disorder involving mainly the intestinal tract. It afflicts 6 million people in the USA and Europe, with annual care costs of 5.6 billion euros, ranking 1 of the 5 most expensive gastrointestinal (GI) disorders. Individuals with IBD experience clinical GI symptoms and reduced quality of life.
Much of the impact of IBD is because it is diagnosed late in time - a major drawback since by then the inflammatory process has often already caused irreversible structural damage to the digestive tract. IBD is a relapsing condition; therefore, diagnoses can be missed if tests are carried out during remission.
IPDx has developed the world’s first single test for rapid inflammatory bowel disease (IBD) detection. IBD is an umbrella term referring to two hard to diagnose chronic intestinal diseases: ulcerative colitis (UC) and Crohn's disease (CD). To accomplish this, the IBDetect test features unique biomarkers, and the patent pending 2 Step Lateral Flow (2SLF) point of care (POC) platform to reveal these disease-specific antibody signatures from patients' blood in a cost-effective manner.
It is important for the society because the incidence of IBD is rapidly increasing and expanding to different regions. Therefore, the health care systems are looking for ways to reduce costs without impacting the quality of patient care. While progress has been made in the treatment and the management of IBDs, diseases are still detected only after they have become symptomatic. However, for half the patients this results in late diagnosis, a major drawback since often the optimal treatment and management is already adversely affected.
The given SME Instrument Phase 1 project is a vital step before entering the final R&D and market entry phase. During the Phase 1 study we conducted a comprehensive feasibility study that includes both technical and commercialisation aspects of the innovation.
Much of the impact of IBD is because it is diagnosed late in time - a major drawback since by then the inflammatory process has often already caused irreversible structural damage to the digestive tract. IBD is a relapsing condition; therefore, diagnoses can be missed if tests are carried out during remission.
IPDx has developed the world’s first single test for rapid inflammatory bowel disease (IBD) detection. IBD is an umbrella term referring to two hard to diagnose chronic intestinal diseases: ulcerative colitis (UC) and Crohn's disease (CD). To accomplish this, the IBDetect test features unique biomarkers, and the patent pending 2 Step Lateral Flow (2SLF) point of care (POC) platform to reveal these disease-specific antibody signatures from patients' blood in a cost-effective manner.
It is important for the society because the incidence of IBD is rapidly increasing and expanding to different regions. Therefore, the health care systems are looking for ways to reduce costs without impacting the quality of patient care. While progress has been made in the treatment and the management of IBDs, diseases are still detected only after they have become symptomatic. However, for half the patients this results in late diagnosis, a major drawback since often the optimal treatment and management is already adversely affected.
The given SME Instrument Phase 1 project is a vital step before entering the final R&D and market entry phase. During the Phase 1 study we conducted a comprehensive feasibility study that includes both technical and commercialisation aspects of the innovation.
The project managed to achieve its main objectives by helping to prove the technical and economic feasibility of the innovation. We carried out interviews with end-users to define the market requirements, conducted a detailed reimbursement analysis for the planned test, and updated our freedom-to-operate (FTO) assessment and business plan according to the results of our end-user study.
As the results of the feasibility study are confidential, there are no specific exploitation and dissemination activities planned beyond the recognition of support from the EC.
As the results of the feasibility study are confidential, there are no specific exploitation and dissemination activities planned beyond the recognition of support from the EC.
As the project consisted of a feasibility study there was no progress in terms of technical development as defined on a Technology Readiness Level (TRL). However the expected results will have a significant impact on the further development of the test. As such we expect to have a significant impact for the 6 million people affected by IBD and lower the annual care costs of 5.6 billion euros once we have finalized the test and validated its performance on clinical scale.