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PneumoSIP – a cost-effective solution for the rapid diagnostic of pneumonia

Periodic Reporting for period 1 - PneumoSIP (PneumoSIP – a cost-effective solution for the rapid diagnostic of pneumonia)

Reporting period: 2014-10-01 to 2015-02-28

PneumoSIP project aims to be the first fully automated device in the POC market for the fast quantitative aetiological diagnose of Community-Acquired Pneumonia (CAP) also analysing antibiotic resistances to enable the most appropriate treatment for each infected patient.
CAP is known to affect about 1/1,000 of the adult population per year, being even higher in the elderly and children populations. It is the fourth case of death in the world, and the leading cause of death in child population under 5 years old. The disease starts when the infectious agent enters the alveolar spaces of the lung, initiating an inflammatory response which leads to the clinical features of coughing, sputum production, breathlessness and sometimes chest pain and haemoptysis. The causal relationship between pathogens and pneumonia has been clearly established, being Streptococcus pneumoniae, Haemophilus influenzae type b (Hib) and the respiratory syncytial virus (RSV) the main pathogens responsible for CAP in Europe. Antibiotic therapy is the mainstream treatment for CAP, and the appropriate treatment involves starting empiric antibiotics administration within 8 hours of hospital arrival. Given this time constrain, traditional methods for diagnosing the aetiology of CAP have been discarded for CAP guidelines due to the slowness in sample to results. In addition, the effective management of CAP is also challenged due to the appearance of resistances to commonly used antibiotics (40 % cases of S. pneumoniae are resistant to penicillin), which typically result in many patients non-effectively treated and the subsequent hospitalization. Another complication is that S. pneumoniae is a common colonizer of the nasopharynx (up to 70% of healthy population acts as a host), making the simple detection of the bacteria a useless diagnostic method. Moreover, infections occur mostly by new and more aggressive serotypes, for which actual vaccines are not effective. Thus, clinicians need rapid and accurate quantitative tests capable of identifying infectious agents and their potential antibiotic resistances.
Therefore, PneumoSIP project aims to be a compact Respiratory Infectious Diseases diagnostic device providing fast quantitative identification of pathogens involved in CAP, enabling faster and more specific treatments. PneumoSIP seeks to combine laboratory standard precision with the simplicity required for POC applications. To achieve these technical objectives our device will meet the following key characteristics: rapid quantitative detection, accuracy in diagnosis, small and fully automated device, antibiotic resistance tests and affordable price.
The market for PneumoSIP system is the POC market, concretely the Infectious Disease POC testing segment. The POCT segment was valued at $415.4 million in 2012 and is expected to reach $966.0 million in 2019, expanding at a CAGR of 12.8 per cent between 2012 and 2019 (only Western Europe data). Based on this positive market growth rate and taking into account that more than about 400 million people suffer from CAP worldwide according to WHO statistics, AlphaSIP expects a great reception and a huge impact of PneumoSIP into the POCT market. PneumoSIP will be the first fully automated device capable of correctly diagnosing aetiological causes of CAP and their antibiotic resistances. This will help to save money from hospitalized patients and reducing broad antibiotic therapy.
The main purpose of the PneumoSIP project during Phase 1 has been to ensure the project´s success from the technical, commercial and financial points of view. To achieve these aims, the outcome of the previous Phase 1 project is here presented as a feasibility study providing an in-depth analysis of the objectives, requirements and all the necessary information to enable our company, AlphaSIP, to come to firm conclusions regarding the project´s viability. A detailed evaluation of the individual objectives addressed in the technical, commercial and financial feasibility studies for the PneumoSIP project as well as the different task and activities carried out are presented. The main objective of this document was acting as yardstick for the decision to launch this venture based on these three reports. This is supported by the 5 years Business Plan included at the end of this document.
According to WHO´s statistics, more than 400 million people suffer from CAP worldwide, being the leading cause of death in children. An efficient management of CAP involves starting empiric antibiotics administration within 8 hours of hospital arrival, however there is a time constraint since traditional methods for diagnosing the aetiology of CAP have been discarded for CAP guidelines due to the slowness in sample to results. In addition, the effective management of CAP is also challenged due to the appearance of resistances to commonly used antibiotics, which typically result in many patients non-effectively treated and the consequent hospitalization.

Recently, the White Book edited by the European Respiratory Society estimated that the annual financial burden of pneumonia in Europe amounted to more than €10 billion, mainly due to hospitalisation and lost working days. Pneumonia accounts for >30% of hospital days in respiratory units (inpatient care accounting for around €6 billion annually) and loss of work days generate indirect costs of more than €3.5 billion. The median direct costs of treating patients hospitalized with CAP were ~€1500 per case. These data enhance the need for improving CAP management.

Considering that that overall incidence of CAP in general practice in Europe is reported to range 1.7–11.6 cases/1000 people/ year (solely in adults), PneumoSIP solution is expected to be used for the more than 3370 000 cases that are expected annually. Furthermore, CAP is the leading infectious cause of death in children worldwide, so the impact of PneumoSIP over child population will be the major social benefit. Therefore, PneumoSIP will provide an accurate fast identification of CAP pathogens and antibiotic resistance tests aiding physicians in providing rapid and focused therapy, which will substantially reduce healthcare costs, improving patient outcomes and contributing to the urgent global fight against antibiotic resistance
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