The problem of antibiotic resistance is considered one of the largest threats to human health by the World Health Organization (WHO). In EU and the US, antibiotic resistance infections have been estimated to cause > 48 000 deaths from 2,5 million resistant infections and confer an economic cost of over € 60 billion yearly. (Antibiotic resistance threats in the United States 2013, Centers of disease control and prevention (CDC) and
http://www.euro.who.int/en/health-topics/disease-prevention/antimicrobial-resistance/data-and-statistics(odnośnik otworzy się w nowym oknie)).
Todays diagnostic methods of antibiotic resistance are slow, resource-consuming and/or non comprehensive. It takes between 48h to a week to get a full resistance determination, resulting in a overreliance on empiric antibiotic treatment, resulting in higher morbidity and mortality, increased transmission of infectious agents in between patients and longer hospitalization. In the EU, 5-12 % of the hospitalised patients will aquire an nosocomial infection during their stay.
1928 Diagnostics (1928D) is developing a diagnostic software solution that takes advantage of the recent developments in modern DNA sequencing technology called next generation sequencing (NGS) to reduce the diagnostic procedures of antibiotic resistance determination to < 12 hours. NGS technology is already frequently used in hospital settings, but mainly for research purposes. The focus on research applications with the NGS technology is primarly due to the lack of automated analysis tools for the challenging data analysis required to handle the clinical routine samples at the hospital laboratories. 1928D addresses this lack of automated diagnostic analysis tools for NGS data by developing a NGS software-as-a-service that will automatically generate resistance profiles and bacterial species identification (typing) in less than 15 minutes. This is achieved by combining cloud computing and automated bioinformatics into a cloud-based software that handles the large data set generated from the NGS machine. The only thing that will be required at the hospital laboratory for the analysis is an internet connection in order to upload NGS raw data files and to download the software generated resistance and typing profiles that will be used as a decision support for the doctor in the choice of correct antibiotic treatment.
The usage of NGS based diagnostics will result in shortened time from patient sampling to treatment, resulting in reduced mortality due to earlier treatment (12 hour compared to > 48 hours with present methods); less transmission of resistant bacteria due to shorter time a patient carries the bacteria; and diminished costs for the health care system and society due to shorter hospitalisation, better recovery, shorter time away from work etc.
The overall aim of the innovation project is to deliver novel state-of-the-art, automated bioinformatics for analysis of NGS to the hospital laboratories resulting in faster and more efficient diagnosis of bacterial infections. The overall objectives of the innovation project are:
I. To generate a fully developed software-as-a-service for direct customer use, preparing for launch in markets selected in the currently proposed feasibility study
II. Preparation of regulatory documentation for CE mark application
III. Preparation for clinical studies to validate the software and to benchmark against competitors.
Our company has the following specific objectives:
1) Identification of key markets for conducting clinical pilot studies.
2) Define the country specific regulatory demands for setting up clinical pilot studies.
3) Understanding the country specific reimbursement policies for sales of diagnostic tests.
4) Establish contact with key opinion leaders within infectious disease and heads of clinical laboratories in selected markets.
5) Establish agreements with clinical laboratories where the pilot study can be done.
6) Generate a business plan that includes a complete roll-out plan for the innovation project, including funding requirments, cash-flow porjections, benchmarking against competing solutions, IP strategy, market analysis and partnering options.
