Periodic Reporting for period 1 - AntibioDx (AntibioDx: A groundbreaking in vitro diagnostic device with a billion-dollar sales potential) Reporting period: 2015-09-01 to 2016-02-29 Summary of the context and overall objectives of the project AntibioDx, a ground-breaking in vitro diagnostic device with a billion-dollar sales potential, which was awarded a €50.000 Horizon 2020 phase 1 (feasibility) grant in 2015. The overall objective of this project is to make AntibioDx the new global gold standard for diagnosing BSI and to see AntibioDx fully commercialised.The feasibility of achieving this overall objective is determined by assessing the feasibility of the AntibioDx device project in terms of:- Achieving US FDA regulatory approval (de facto global clinical validation standard)- Delivering on projected clinical-value propositions- Commercial viability- Large-scale production of the AntibioDx device to GMP-standardsThese assessment criterias translate into 4 deliverables for this H2020 Phase I project:1. Assess and determine a clinical validation study design for ensuring and accelerating US FDA regulatory approval.2. Outline a clinical impact analysis model for quantifying the potential improvements in patient-outcome and antimicrobial effectiveness from implementing AntibioDx. 3. Develop a business plan and clinical acceptance strategy for accelerating and maximising exploitation of the commercial potential of AntibioDx.4. Initiate the building of a compelling case for Phase II funding based on the above Phase I activities and findings/conclusions. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far The feasibility study resulted in the following:• Clinical validation studies have been designed to meet both EU and US regulatory requirements with a total budget of €988.000.• AntibioDx has the potential to save the lives of 0.5 million patients and save €18 billion in hospital costs annually according to an outcome simulation model.• €2 million is required to bring AntibioDx through clinical validation and additional €3 million is required for commercialization.• The market is 10.000 hospitals in EU and 5000 hospitals in US with an average sales potential of €250.000/account and thus a market potential of more than a €1 Billion. • AntibioDx breaks with the convention, which continues to be a barrier to attract grants and investments from private and public investors and funding bodies who prefer to wait for clinical validation data.In conclusion, the Horizon 2020 phase 1 project has successfully been used to finalize a business plan with important milestones to make AntibioDx a new clinical Gold Standard and build a Billion Dollar company, however, AntibioDx continues to be in a ‘Catch 22’ situation where grants and investment is depending on clinical validation, which require funding. Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far) Annually 18 million people are affected by bloodstream infections worldwide. According to the outcome simulation model, AntibioDx has the potential to save the lives of 0.5 million patients and save 18 million bed-days, which at an average cost of €1000 per bed-day is equivalent to €18 billion annually. AntibioDx Transition Map
