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Development of simple to use point of care tests for zoonotic pathogens and their validation for use in clinical research setting

Periodic Reporting for period 1 - ZOONOMARKS (Development of simple to use point of care tests for zoonotic pathogens and their validation for use in clinical research setting)

Reporting period: 2015-05-01 to 2015-10-31

"The Project has the title ""Development of simple to use point of care tests for zoonotic pathogens and their validation for use in clinical research setting"" (acronym: ZOONOMARKS).

Our major goal has been development of simple to use point of care tests for zoonotic pathogens and viral hemorrhagic fevers (VHF), and their validation for use in clinical research setting.

In the project we have one Work Package (WP) titled ""Feasibility study"". The WP started on the beginning of month 1 its work aiming on its sole Deliverable D1.1 at month 6.

Feasibility study comprises of
1. The business opportunity analysis including competitor analyses, customer surveys and other relevant business related topics.
2. Any IPR and FTO issues will be dealt with by team members together with patent attorney when needed.
3. The feasibility study on the project objectives 1-4 will be worked out by the team members.
4. Validation protocols are laid by the team, and the performance evaluation studies will be designed with validated sample panels and fresh healthy volunteer and patient samples together with the present key
collaborators, and also new collaborating partners. The collaborating partners from leading universities and research institutions act as service providers.
5. Market study reports will be acquired from service providers.

The Deliverable leads with the help of expert consultation to a Deliverable Report.

Our ultimate goal is to produce a comprehensive Business Plan in order to in phase 2 to develop a comprehensive rapid response diagnostic system for zoonotic pathogens and hemorrhagic fever viruses, with implications for surveillance of all emerging pathogens. Furthermore, in phase 2 the developed tests will be evaluated by end users of the tests – by several research and clinical diagnostic laboratories.
"
We have started on month 1 the following:
- The business opportunity analysis including competitor analyses, customer surveys and other relevant business related topics
- Dealing with the IPR and FTO issues
- Dealing with WP objectives 1-4
1. a direct pathogen inactivation and validation of the inactivation technique for patient samples which eliminates risks during subsequent handling;
2. novel simple point-of-care methods to detect zoonotic bacterial and viral antigens;
3. novel simple point-of-care method to detect human IgM and/or IgG antibodies against zoonotic bacteria and viruses in saliva, urine, and fingerprick blood;
4. a portable next generation rapid diagnostic tools for detection of genetic markers of zoonotic pathogens

- Several potential collaborating partners from leading universities and research institutions have been identified and contacted. Discussions with them as service providers have been opened (re: validation protocols and clinical studies)

On Month 2 we did acquire the first Market study reports from an international service provider. The full work on these study reports was accomplished on months 4-6.

Furthermore on Month 2 we did start discussions on the possible consults with the EEN National Contact Point. Five possible consults were identified, and the work aimed to start with one of them on Month 4. However, the consultation was not started due to delays in the process, and will commence after the Phase 1 as communicated with the EEN National Contact Point.

Between months 3-4 we have continued discussions with the present key collaborators, and also contacted new collaborating partners. The collaborating partners from leading universities and research institutions act as service providers.

We are ready to continue with the Phase 2 application by the next cut-off.
Reagena’s Hantavirus products are well known in the European market. With the high performing rapid tests, Reagena is established as the market leader in this segment for almost a decade in the European market.

Need of improved methods is one of the key growth drivers in the immunodiagnostics segments, which Reagena is addressing. Discovery of new variants necessitates continuous test development and improvement. Reagena aims to develop tests for detecting all major variants within the respective major endemic area, which is a key factor of growth and success. The endemic zoonosis areas are gradually expanding to new geographical areas, which is another important market driver. Geographical distribution of different hantaviruses is well known. Tick-borne encephalitis appears in European and Asian markets, while Borrelia is more widespread in all the Northern continents.

The majority of testing with Reagena products is done in clinical hospital, institutional and commercial laboratories and in primary care setting. Local practices vary between countries. There is an increasing need for and adoption of faster, decentralized technology and products, such as Reagena is offering. Availability of a rapid test in diagnostic setting enables faster treatment and brings time and cost savings in the therapeutic process. Recently launched, truly unique TBE test is an example of this, resulting from a thorough research and development and utilization of core competence of Reagena.

Specific market data and external market research reports were acquired during the project for the new zoonosis segments and tests, such as Borrelia and other tests/segments, which Reagena is targeting to enter.
Rapid diagnostic product example