IP protection

PART B: VALORISATION PLAN

 

1 Please provide a short description of the state-of-the-art and/or current trends in the field? How does the result fit into it?

Strategic tuberculosis research focuses on development of new diagnostics, faster-acting treatment regimens, and more effective TB vaccines, as well as their rapid deployment. Rapid and accurate TB diagnosis is critical to TB patient care and arresting disease transmission.

PCR-based diagnosis detects the presence of the pathogen in body fluids; operating the system, however, needs skilled personnel and positive diagnosis often refers to latent infection. Further diagnostic tools under development are also based on the presence or cultivation of the pathogen, exposing the health providers to infection. Similarly, the phage-based system and the saliva-based assay test needs cultivation and direct manipulation with the pathogen.

Proteomic research in TB diagnostics utilizes host response to pathogen antigens in holistic approaches by antibody target recognition. Another approach is the SELDI-TOF-based identification of diagnostic markers for tuberculosis by serum profiling.

All the current trends in TB diagnosis are laborious, need skilled personnel; often include direct manipulation with the pathogen that collectively argues against broad application in resource-poor epidemic countries.

Our proposal, however, is based on biomarkers with low diagnostic value for each serum protein, but in combination of poorer markers a high specificity and selectivity of TB diagnosis will be achieved by multiple marker screening. This diagnostic tool will be a  low-cost, point-of-care test, based on an instrument-free, laboratory-free method. The TB diagnostics pipeline of the World Health Organization expects diagnostic tools for TB with these criteria by 2015.

 

2 What is the problem/need/knowledge gap that the research result is responding to?  How was it addressed before?

There is an acute need to stimulate research and development of modern TB tools to fight the evolving epidemic. For decades, much of the industrialized world thought TB was defeated, and investment in TB research and development essentially dried up. The drugs, vaccine, and diagnostics used to fight TB were antiquated, slow, and ineffective, and they were being implemented in the context of weak health systems.

Sputum smear microscopy, the standard diagnostic used in the developing world, is more than 100 years old. It fails to detect more than half of all active cases, is labor-intensive for both the patient and the health provider. In industrialized countries, where the TB burden is relatively low, TB diagnosis relies on high-tech molecular techniques and rapid culture systems. These tests have not been implemented in high-burden developing countries due to their level of sophistication and cost. It has been estimated that improved TB diagnostics could help save at least 400,000 lives every year.

 

3 What is the potential for further research?
Beyond marker discovery, we aim to address pathognomic conditions of tuberculosis: We anticipate that data will give an insight into the mechanism that result in a failure of pediatric and adolescent TB patients to thrive, as part of the clinical phenotype involving those gene expressional alterations that affect skeletal development. We also anticipate to gain insight into an enigma that dates back two millennia, the association of TB with diabetes through gene expression changes that affect pancreatic function.

 

4 What is the proposed method of IPR-protection? (patent, license, trademark etc.)
For IPR-protection we suggest patenting the results at national/international levels.

 

5 What are the steps that need to be taken in order to secure the IPR-protection? What is the cost of IPR-protection?
Submittal of a national patent application. Cost of application approx. HUF 300,000.

Initiation of international procedure with a PCT application, the cost of which is approx. HUF 1,000,000.

 

 

 

 

6 What is you overall assessment of the scientific maturity of the research result?

Gene expressional alterations in a natural model system of tuberculosis were observed by DNA-array experiments using all commercially available platforms and by transcriptome sequencing. Our set of the genes with expressional alterations derive from overlapping results determined by independent methods and were published in peer-reviewed journals. This research was funded by the sources of the FP6 of the EU; implementation of this project proposal would be a logical continuation of our former research. Collecting gene expressional data from humans is impossible owing to ethical and technical limitations. The set of the candidate genes are orthologous, highly conserved structurally-functionally among vertebrates. Therefore we anticipate that similar down- or upregulation in gene expression will be observed in TB patients.

The set of candidate biomarkers consists dozens of genes that were selected by their abundance in human serum, literature search and antibody availability. The expected concentrations of the candidate markers in the human blood serum are in the range of easy detection by conventional clinical chemical means.

 

 

KEYWORDS QUANTITATIVE ASSESSMENT (0-5).

Please put X as appropriate. 1 2 3 4 5
Scientific maturity         X
Synergies         X
State-of-the-art/innovation         X
IPR-potential         X

 

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