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Ultra Legionella Inmunoanalysis System for Early Sensing

Periodic Reporting for period 1 - ULISENS (Ultra Legionella Inmunoanalysis System for Early Sensing)

Reporting period: 2016-06-01 to 2017-05-31

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.
As general objective of the project, all the work carried out during this reporting period has been oriented towards the achievement of this goal. At this point of the project, it has been defined main aspects related to the final product prototyping (WP1) and the testing and product certification (WP2). This work has been complemented by the progress performed in non-technical aspects, related to the exploitation and commercialisation aspects and also, in the dissemination and communication actions of the project (WP5).

More specifically, within WP1, it has been performed the development of the pre-industrial prototypes for the different versions, including all relevant aspects involved in the system (mechanical block and system architecture, hardware and software). Two different versions, LAB and TOWER, have been developed, following main requirements and specifications obtained from stakeholders. As the engineered systems are equivalent, efforts have been focused on the TOWER version, and then they have been adapted to other versions (LAB and BUILDING) according to the user needs identified. All the technical solutions have been industrialised and miniaturised to facilitate the production considering both performance and cost as critical issues.

Within WP2, the actions have been focused on testing of new products for performance and safety verification in order to obtain the specific product marking. Verification of compliance with applicable standards and product characterization has been performed, including testing and validation. These tasks have also been oriented towards product certification, aiming to identify and follow the regulatory and legislation aspects. At this point, the company has received the compliance attestation by the manufacturer (IDNEO) related to the ULISENS functional Alpha prototypes, confirming that the units have been designed according to standards.

Within this period, there have been a lot of activities related to the preparation for market introduction, mainly related to the establishment of contacts with relevant stakeholders in each of the market segments considered and the start of commercial contacts for further market replication. More specifically, a total of 22 stakeholders, including companies, public entities and others, from different countries, have been contacted and visited, achieving very positive outcomes. Added to this commercial work, specific actions related with the communication and dissemination activities, have been also successfully performed. As an example of stakeholder, a Hospital can be mentioned where a preliminary study has been conducted using the rapid test that is basis of this project. Positivity of their water network was monitored by this test in two rounds, one before and the other after application of cleaning and disinfecting procedures. Positivity detected by the test decreased after treatments showing their utility for the fast monitoring of the treatment process. Critical points to be controlled were identified so that this real scenario will be candidate to receive a demonstrator.

The rest of the objectives will be developed and performed during the following months.
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.