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Quick Sepsis Test

Periodic Reporting for period 1 - QUIST (Quick Sepsis Test)

Reporting period: 2015-01-01 to 2015-06-30

Sepsis is a potentially fatal whole-body inflammation that is caused by the response of the immune system to an infection. The infection is often caused by bacteria, either by Gram-positive or Gram-negative bacteria. The number of patients with sepsis is increasing steadily worldwide due to a lack of quick and good diagnostic tests, the aging of the population, the use of invasive diagnostic techniques and an increase in bacterial resistance to antibiotics. The estimated incidence of sepsis worldwide is 20 million patients per year. With 20.000 deaths per day, the mortality rate of sepsis is 36%. Since elderly are at increased risk, it is likely that sepsis will become one of the leading causes of death worldwide with the aging of the population. Overall, sepsis causes a significant socioeconomic burden. The length of hospital stay and the price of therapies leads to high costs in sepsis. It is therefore evident that sepsis is a medical emergency. Each hour of delayed treatment decreases a sepsis patient’s chance of survival with 8%. Early sepsis diagnosis is thus very important in reducing mortality. Over the years the understanding of the molecular biology of sepsis has increased considerably. Surprisingly however, no good quick diagnostic tests for sepsis exist. This is due to a lack of sensitive and specific biomarkers. The disease is often still defined and diagnosed by blood culture tests which are time-consuming and can take up to 2 days. This is far too long to save lives. Sepsis-specific biomarkers that reflect the cellular processes involved in the disease would greatly contribute to the clinical diagnosis of sepsis. Several biomarkers have been proposed for sepsis. None of these, however, is sufficient for sensitive and specific sepsis diagnosis. Therefore novel diagnostics and treatment strategies are urgently needed to improve the outcome of sepsis and reduce sepsis related healthcare costs. We have identified a biomarker panel for sepsis which has the potential to drastically change sepsis diagnostics. This biomarker panel now needs to be clinically validated. The biomarker panel contains several proprietary as well as known and novel biomarkers. Once validated, the biomarker panel will be further developed into a point-of-care test (POCT) to diagnose sepsis and monitor disease prognosis. The sensitivity and specificity of this test will outperform current sepsis tests. Ultimately this will result in two products: 1) intellectual property based on the biomarker panel, with the goal to out-license this to vendors of clinical analyzers and 2) a POCT for sepsis.
In QUIST, a feasibility study has been performed in order to gain better insight in the risks and potential hurdles for a validation study of the identified biomarker panel and in the future exploitation of the project’s results. This feasibility study contained technical, commercial and economical issues, which has resulted in a businessplan.
In the feasibility study, a bottleneck analysis has been performed in order to nominate the most critical parts in a validation study, containing risks and potential hurdles. Also, a market study has been performed and an IP management strategy developed. The feasibility study comprised literature searches, desktop research, attending conferences and meetings with stakeholders (companies involved in clinical diagnostics, POCT, hospitals, patent officers etc).

Bottleneck analysis
Technical challenges that have been identified are 1) the establishment of biomarker reference values, 2) the establishment of analytical variation with respect to sensitivity, dynamic range and reproducibility, 3) sampling, provision and storage of samples, 4) the sensitivity and specificity of QUIST and 5) POCT development. These hurdles will be overcome by implementing go-no go decisions in critical parts of the validation study and the product development process whenever possible. Partners for providing samples have been identified and committed to the project. Regulatory demands for POCT development have been studied and summarised and design requirements listed.

Market study
A market study has been performed to identify potential customers, competitors and competing biomarkers and technologies. The clinical diagnostics market is very large, estimated to be 30 billion EUR in 2012 globally. Hospitals and large commercial clinical labs represent the majority of the market (80%), followed by POCT in hospitals and emergency units and general pratitioners (10%). Leading technology segments include chemical analyzers, immunoassays, flow cytometry and molecular diagnostics. The clinical diagnostics market is estimated to grow at 7% anually the coming years. Infectious diseases make up 30% of the market for clinical diagnostics. The sepsis diagnostic market is dominated by several large diagnostics companies. Most important competing technologies are based on microbial identification, like PCR and mass spectrometry. Such approaches are suitable for finding the right treatment options but are slower and not suitable to diagnose the disease severity and monitor prognosis. Therefore microbial analytical solutions are complementary and not truely competitive to our approach. Based on this information, a marketing and sales plan has been composed. The market share in 5 years has been determined as well as the price for tests based on QUIST. Unique Selling Points and Unique Buying Reasons have been identified.

Strategy for IP management
A strategy for IP management has been developed. Criteria have been defined for future patents. Royalty rates have been established and potential industrial partners for out-licensing patents are identified. A list of distributors that can contribute to the commercialisation of the sepsis POCT has been composed. Financial risk analysis has been performed.

A projectplan has been made, including workpackages, collaborative partners, project management, costs and Gantt chart for 1) analytical method development and validation, 2) establishing biomarker reference intervals, 3) determination of sensitivity and specificity of the biomarkers, 4) challenge study to determine the diagnostic accuracy, 5) an advanced clinical phase and 6) POCT development. The projectplan contains several go-no go decision moments to minimize financial risks. Investment needs have been mapped.
The QUIST project has resulted in a solid businessplan and a research plan for the validation study, addressing technical, commercial and financial hurdles. The businessplan and projectplan will be used for applying for a Horizon2020 phase 2 grant and will form the basis for negotiations with investors.

QUIST changes the way in which sepsis is diagnosed and treated. By offering a quick test at relatively low costs, tests based on QUIST will contribute to the reduction of health risks in critically ill patients and consequently the treatment-related costs of sepsis. The length of hospital stays and inappropriate antibiotic treatments can be significantly reduced with rapid diagnosis, ultimately also resulting in a decline in hospital costs. In turn this will also lead to improved targets for sepsis therapeutics.

From a company perspective, QUIST will be an important contributor to the growth of the company in terms of turnover and personnel. The development of QUIST will provide spin-off to other biomarkers and POCT’s ultimately evolving into a hybrid service and product-focused company.