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Ultra Legionella Inmunoanalysis System for Early Sensing

Periodic Reporting for period 2 - ULISENS (Ultra Legionella Inmunoanalysis System for Early Sensing)

Reporting period: 2017-06-01 to 2018-05-31

Legionnaires’ disease (LD) is the severe and sometimes fatal form of an infection caused by Legionella organisms (legionellae). LD is classically described as a severe pneumonia that may be accompanied by systemic symptoms such as fever, diarrhoea,
myalgia, impaired renal and liver functions, and delirium. These gram-negative bacteria are found in freshwater environments worldwide and tend to contaminate man-made water systems. Last published European surveillance reported a total of
5.501 and 5.852 official LD cases in 29 European countries from 2011 and 2012, respectively. The clinical outcome was 693 of them died, yielding a case fatality rate (CFR) of 11%, which was similar in both years. Although most of the cases were
registered in France (24%), Italy (19%) and Spain (18%), the increase registered in Germany (11%) and the Netherlands (7%) makes LD a challenge for the whole Europe. Water quality policies and regulations supporting preventive risk management is a strategic outcome in the Water Quality and Health Strategy 2013-2020 of the WHO. This fact supposes a high amount of facilities to be controlled and, therefore, a very high number of laboratory tests to be done. Only in Europe there are more than 500,000 cooling towers, to be added to other numerous risk facilities (as more than 30,000 risk installations at public buildings related with Leisure such as hotels, spas, sport centres and commercial centres, and more than 225,000 risk installations in public buildings related with Health such as hospitals and nursing homes), which need also to be controlled. For this reason, a hypothetical number of tests per year could be around about 100 million, with an estimated market volume of up to 5.000M€.

There are some existing solutions in the market to detect Legionella spp in water but all of them present some limitations.The general objective of ULISENS project is focused on the development and further commercialization of an automatic early warning system able to detect and quantify Legionella species in water. The system integrates an innovative fast detection biotechnology with an automated module able to carry out ‘in situ’ analysis in real-time to minimise time to results. ULISENS reduces the Legionellosis lethality from 12% to 2% because of TIMELY AND COST-EFFECTIVE EARLY WARNING to risk owners to take preventive measures as soon as possible. Therefore, it prevents: Shutdown times and extra cleaning costs; Health authority penalties; and Brand discredit due to infections.
All the work carried out during the project has been oriented towards the achievement of the overall objective of the project, focused on having ready the different commercial versions of the product and having started the commercialisation phase, with some arrangements close to be signed. At this point, after the second period, it can be stated that the objective has been achieved, both at technical and commercial level. At technical level, the final units of the different versions have been totally developed, having received the compliance attestation by the manufacturer confirming that the units were designed according to standards. In addition, actitivies focused on the design and implementation of a reagent production line at pilot scale have been performed, in order to validate and optimise the supply chain of the system for further scaling-up. It is important to highlight that this development will contribute to the definitive entrance of the product to the market, being able to cover the foreseen demand for the first period of operation. Apart from this, other relevant aspects for ensuring quality and for monitoring consistency of the process, with specific procedures and testig have been executed.

Related to the exploitation actions, a total of 32 stakeholders with possible interest in the solutions at different levels have been contacted, establishing in some cases specific cooperation agreements for market entrance. In addition, the participation of BIOTICA in more than 25 dissemination activities, including tradeshows, conferences, workshops and trainings, have also contributed to the positioning of the product in the market. In summary, it is expected that in the remaining months of 2018 and the beginning of 2019, the first commercial arrangements will be signed, starting since then an exponential increase in sales and commercial agreements, confirming the succesful introduction of the product in the market at international level.
One of the most relevant H2020 health challenge is to improve our ability to prevent, detect, treat and manage disease by controlling in situ the living causal agent. EC directives establish the legal framework for minimum level of control of potential
risk facilities through “official culturing analysis of Legionella”. But BIOTICA detected that exists a potential market of customers that want to prevent the infection using its own control system, establishing more stringent quality controls than the required by the legislation, not only for their social responsibility but also to protect their brand (Industries, Hospitals, Hotels…). With this regard, managers demand a quantitative tool for an easy integration of Legionella control in its system to prevent health risks. The desired system should be operated by non-expert staff and show fast results with low cost. ULISENS system responds to these industrial needs, by offering an Early Warning System based on a certified and fast detection BIOTECHNOLOGY with very low complexity able to quantify in real-time Legionella species at risk facilities (on-site) with a unitary cost per test up to six times lower than existing technologies. ULISENS concept involves a disruptive change in the control of legionella infections. ULISENS accelerates the identification of the suspected focus of infection for preventive closure and, at the same time, allows monitoring and controlling the concentration of Legionella in situ before the outbreak. In summary, ULISENS is the only technology able of effective control at unbeatable price, thereby reducing the cost of non-prevention.