Braunschweig, Germany
Braunschweig, Germany

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Patent
Lionex GmbH | Date: 2017-05-24

In a first aspect, the present invention relates to the use of a device, like a microtiter plate having multiple predetermined reaction areas, like multiple wells, wherein the device with the multiple predetermined reaction areas, like the wells of the microtiter plate, do not contain any membrane or other structure present in or on the predetermined reaction areas, e.g. fitted into the well, for use in an enzyme-linked immunospot (ELISPOT) assay. Surprisingly, the inventors identified that the ELISPOT assay can be performed using simple devices the the multiple predetermined reaction areas, like the microtiter plates without the need of any kind of membrane or other structure present in or on the reaction areas of the deivce, like fitted into the well, for increasing surface area etc. In a further aspect, the present invention relates to an ELISPOT assay based method for determining compounds secreted from culture cells whereby the culturing of the culture cells is conducted in or on the device, like in the microtiter plates according to the present invention. Furthermore, a test kit for use in an ELISPOT assay comprising the devices, like the microtiter plates according to the present invention are provided.


Grant
Agency: European Commission | Branch: H2020 | Program: RIA | Phase: PHC-08-2014 | Award Amount: 8.00M | Year: 2015

Tuberculosis (TB) is a global health problem, killing 1.5 million of people every year. The only currently available vaccine, Mycobacterium bovis BCG, is effective against severe childhood forms, but it demonstrates a variable efficacy against the pulmonary form of TB in adults. Many of these adult TB cases result from the reactivation of an initially controlled, latent Mycobacterium tuberculosis (MTB) infection. Effective prophylactic vaccination remains the key long-term strategy for combating TB. Continued belief in reaching this goal requires unrelenting innovation in the formulation and delivery of candidate vaccines. It is also based on the assumption, that the failure of recent human vaccine trials could have been due to a sub-optimal vaccine design and delivery, and therefore should not erode the key principle that a TB vaccine is an attainable target. This proposal focuses on mucosal vaccination, which has been considered in the past, but not implemented efficiently. The innovation of the proposal is focused on several important aspects of vaccine development and testing, including the use of novel technologies for vaccine delivery, novel ways of specific targeting of mucosal immune cells and tissues, the use of polypeptides incorporating early and latent MTB antigens and putative CD8\ T cell epitopes, and application of novel tools for identifying early predictors and correlates of vaccine-induced protection. The overall objective is to design a vaccine that will induce a broad-ranging immune response to MTB both systemically and in the mucosa of the lungs, and provide the currently missing links in protective immunity to this pathogen.


Grant
Agency: European Commission | Branch: FP7 | Program: CP-CSA-Infra | Phase: INFRA-2012-1.1.5. | Award Amount: 10.96M | Year: 2013

HIV/AIDS, Tuberculosis (TB) and Malaria alone account for more than six million deaths worldwide every year. Despite substantial efforts made in recent years, Poverty Related Diseases are still spreading. New therapeutic interventions are therefore urgently required to combat Poverty Related Diseases. The existence of a well-developed HIV/TB/Malaria infrastructure presents a prime opportunity to address other sexually transmitted diseases such as viral hepatitis efficiently and effectively. The overall goal of the EURIPRED is to coordinate and integrate international resources into a single specialised infrastructure to support European HIV, TB, Malaria and Hepatitis B virus and Hepatitis C virus studies from early drug, vaccine and microbicide discovery to clinical trials. This will be achieved by creating partnerships between European scientists and international research teams from disease endemic countries and strong collaborations between industry and public sector research. Although vaccines, drugs and microbicide research is being conducted in the European Union (EU) there is no single European infrastructure that brings international resources and facilities together to develop cost-effective products for the European market. To underpin this need, EURIPRED will integrate worldwide resources to allow European access to shared reagents. This integrated approach will strengthen international cooperation, increase research capacity in EU and developing countries and significantly contribute to the European Research Area (ERA). By minimising fragmentation and duplication of research efforts and pooling fragmented resources EURIPRED can improve European research efficiency and effectiveness. EURIPRED will be built upon the highly successful model of the Centre for AIDS Reagents (CFAR), a twenty-three year old reagent initiative based at the National Institute of Biological Standards and Control (NIBSC), a centre of the Medical Healthcare Products Regulatory Authority Agency (MHRA) and will comprise of a world-class team of experts and repositories with expertise in vaccine, microbicide and drug development for a range of infectious diseases. By engaging international scientific communities, EURIPRED can play a leading role in driving research forward in Europe and beyond.


Grant
Agency: European Commission | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2012.1.2-1 | Award Amount: 4.60M | Year: 2012

With the advent of Omics technologies capable of profiling substantial fractions of molecular entities from the genome down to the metabolome level a significant boost in understanding disease pathophysiology, consequently providing tailored diagnostics and therapy, was expected. With impressive results for selected diseases, cancer still sees significant shortcomings. One reason for this clinical situation is certainly the apparent heterogeneity of cancers, manifesting in clinical presentation and outcome, but also on the personalized molecular level. Within DIPROMON we selected bladder cancer as a prototypical example for the need of personalization efforts in therapy, and we plan of using this clinically highly challenging disease phenotype for establishing a general workflow for enabling personalization strategies towards rational decision on tailoring therapeutic interventions for defined patient groups. DIPROMON on its basis follows a computational Systems Biology approach for delineating statistical rules for patient segmentation, resting on patient-specific biomarker profiles interpreted in tight integration with patient-specific clinical data. DIPROMON will establish a workflow including quality control aspects for i) selecting biomarker panels for given clinical phenotypes, ii) providing modular instrumentation for measuring the profiles in a clinical setting, and iii) deriving statistics-driven rules for patient segmentation regarding optimal therapy. DIPROMON will finally validate the concept in bladder cancer.


Grant
Agency: European Commission | Branch: FP7 | Program: CP-TP | Phase: NMP.2013.4.0-3 | Award Amount: 4.81M | Year: 2014

The IP4Plasma project aims to bridge the gap between IPR protected laboratory-scale innovations in the field of atmospheric pressure plasma assisted chemical vapour deposition (AP-PA-CVD) technology and its industrial implementation for advanced surface treatment and nano-scale coating of materials. This will be done by demonstrating the suitability of the technology for existing and new industrial applications in the medical products and diagnostics sector. A mobile pilot scale plasma treatment system will be designed and built for this purpose based on existing experience and IPR protected know-how, and subsequently validated in end user production facilities. In the project, the manufacturers of atmospheric pressure plasma equipment and the end users of the technology will work together with research organisations and experts in technology innovation to overcome the barriers to commercial application of a unique IPR portfolio.This will create new business opportunities with large market potential for the industrial partners involved (mainly SMEs), and thus strengthen their global competitiveness.


Grant
Agency: European Commission | Branch: FP7 | Program: CP | Phase: ICT-2013.3.3 | Award Amount: 3.56M | Year: 2013

Pocket will develop a novel point-of-care (PoC) urine test for the detection of tuberculosis (TB), achieving at the same time a low cost (5 to 10 euro end-user cost per test, including depreciation cost of the instrument) and a high accuracy (>80% capture of TB-positive patients, which is much better than the present solutions which reach 60%). The test positions itself between current low-end immunological urine tests with limited accuracy and between high-end expensive nucleic-acid-based tests, which are not truly point-of-care. Throughout this project, special attention will be paid to both end-user requirements (performance, cost, ease-of-use, ...) and to manufacturability. Pocket will go well beyond the development of a mere laboratory prototype, as in the final year of the project, the instrument will be field-tested in Africa and India.\n\nThe combination of low cost and high accuracy will be achieved through a unique integration of several state-of-the-art concepts, which the partners have separately developed and of which the maturity has already been shown:\n\n-a nanophotonic transducer with integrated spectrum analyser developed by UGent (Vernier ring resonator cascade with arrayed waveguide grating spectrometer). This will enable us to eliminate the cost associated with the inclusion of a high-end tunable laser (20k euro) that typically plagues the competing approaches using resonant optical nanophotonic sensors.\n\n-a high-confinement silicon nitride (SiN) platform running in a mature small-volume CMOS fab (imec). The use of SiN as opposed to the more traditional Silicon-on-Insulator material system will enable us to move the operating wavelength from 1550 nm to 900 nm, where both the sources and the detectors are significantly less expensive.\n\n-a novel TB detection system, based on a unique combination of high-quality antibodies for two different biomarkers.


Grant
Agency: European Commission | Branch: FP7 | Program: CP | Phase: SME-2013-3 | Award Amount: 691.20K | Year: 2013

Tuberculosis (TB) in humans and bovine TB in farm animals are global health problems of immense social and economic importance. Human TB: Mycobacterium tuberculosis (M.tb) is a slowly replicating bacillus that resides intracellularly within phagosomes of macrophages and commonly causes latent infections of the lung and in about 5% of the infected individuals it leads to active disease. Co-infection with M. tuberculosis is estimated in about one-third of HIV-1 infected subjects. Indeed, the risk of developing M. tuberculosis as an opportunistic infection is increased up to 200-fold in HIV-1\ subjects. Drug resistance to HIV-treatment and appearance of multiple-drug resistance (MDR) and off late of Extra-Drug Resistance (XDR) strains of M. tuberculosis, the causative agent of human TB is steadily leading to a hopeless situation as far as the therapy is concerned.Bovine TB: Bovine tuberculosis is caused by the bacterium Mycobacterium bovis, which is closely related to Mycobacterium tuberculosis, the cause of human tuberculosis. M. bovis can be transmitted to humans through the ingestion of unpasteurised milk and milk products as well as aerosols, from infected cows. The introduction of pasteurisation eliminated transmission through contaminated milk and greatly reduced the human health problem1. The principal hosts for bovine tuberculosis are cattle and buffalo, however many other domestic and wild animals can become infected e.g. goats, cervids, pigs, wild boars, dogs, cats, camels, badgers, primates, hares, amongst others. Bovine tuberculosis is found worldwide. All developed countries currently have a TB eradication program in place for many years. These programs have been largely successful; however, incidences are increasing in many countries (e.g. UK, Ireland, France, Austria, Germany). The specific objectives achievable within DEMO-NOPERSIST project are 1. Development and evaluation of prototype test kits for active human TB (LIONEX, SME). This test shall be the Worlds first blood test for discriminating latent from active TB in humans. 2. Development and evaluation of prototype test kits for active Bovine TB (PRIONICS, SME) 3. To develop marketable, improved diagnostic products for human and bovine TB within a period of 2-3 years . Thus, both human and bovine active TB tests are directly linked to the NOPERSIST project and shall be an excellent demonstration of a Res4SME project NOPERSIST.


Grant
Agency: European Commission | Branch: FP7 | Program: BSG-SME | Phase: SME-2013-1 | Award Amount: 1.47M | Year: 2013

Molecular techniques such as PCR (polymerase chain reaction) are becoming increasingly used for the detection of respiratory pathogens, due to their high accuracy and relatively fast turnaround time (hours). Their utilization can result in early and specific treatment, contribute to better patient outcomes and reduce length of hospital stay. However, implementation of rapid molecular diagnostics remains limited to large, centralised laboratories which can afford the requirements of dedicated PCR laboratory space, specialized personnel and costly equipment and consumables. Even in central laboratories, timely diagnosis may be undermined by delays during sample transport to the setting and batching practices oriented to save consumables. There is a need for a fast, cost-effective, user-friendly molecular diagnostic point-of-care (POC) instrument for near-patient use at small to medium size hospitals, and decentralized clinical laboratories. The RESPOC platform will be a novel solution designed to detect bacterial and viral respiratory pathogens in less than one hour. Based on the development of DNA extraction and DNA amplification methods integrated into a low-cost microfluidic lab-on-a-chip (LoC) consumable, the platform will deliver results automatically by insertion of the disposable LoC into a small footprint reading instrument. Initially it will identify the target respiratory pathogens Streptococcus pneumoniae (pneumococcus) and Bordetella pertussis. Pre-clinical validation and demonstration of the RESPOC instrument will be performed at the facilities of the RTD hospital participant and at the facilities of the SME end-users to ensure adequate diagnostic performance and usability.


Patent
Lionex Gmbh | Date: 2015-01-14

In a first aspect, the present invention relates to a method for diagnosing or determining the status of tuberculosis infection in an individual afflicted with or suspected to be afflicted with tuberculosis infection. In a further aspect, a method for the stratification of the therapeutic regimen of an individual with tuberculosis infection is provided as well as a method for predicting a clinical outcome or determining treatment course in an individual afflicted with tuberculosis infection. Moreover, the present invention provides a method for monitoring the change from latent into active status of tuberculosis infection or vice versa in an individual. Furthermore, the present invention relates to a kit for use in diagnosing or detecting the status of tuberculosis infection as well as to Mycobacterium tuberculosis alanine dehydrogenase for use in specifically differentiating latent status from active diseases status of tuberculosis in an individual.


Patent
Lionex GmbH | Date: 2014-01-22

In a first aspect, the present invention relates to a method for diagnosing or determining the status of tuberculosis infection in an individual afflicted with or suspected to be afflicted with tuberculosis infection. In a further aspect, a method for the stratification of the therapeutic regimen of an individual with tuberculosis infection is provided as well as a method for predicting a clinical outcome or determining treatment course in an individual afflicted with tuberculosis infection. Moreover, the present invention provides a method for monitoring the change from latent into active status of tuberculosis infection or vice versa in an individual. Furthermore, the present invention relates to a kit for use in diagnosing or detecting the status of tuberculosis infection as well as to Mycobacterium tuberculosis alanine dehydrogenase for use in specifically differentiating latent status from active diseases status of tuberculosis in an individual.

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