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.
Projectplan
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.
