Neuried, Germany
Neuried, Germany

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The present invention relates to a method for the normalization of an immunological test characterized in that the presence of a comparable amount of cells is determined by a sandwich ELISA test wherein the capture antibody is at least one antibody which binds to at least one keratin selected from the group consisting of keratin 4, 5, 6, 8, 10, 13 and 18 and the detection antibody is at least one antibody which binds to said keratin.

Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2012.2.3.0-1 | Award Amount: 4.57M | Year: 2012

The SMEs MIKROGEN and BIOSYNEX are well established in the field of diagnostic tests for infectious diseases in humans and perform active research into innovative products. As a critical step to get access to the lucrative market of diagnostic kits for the detection of persistent infections by human papillomaviruses (HPV), the SMEs teamed up with partner UIBK who developed a unique set of immunological tools suitable for this purpose, and two leading European gynecological clinics with longstanding interest in improving clinical management of HPV-associated diseases. Currently used diagnostic tools can detect HPV DNA in cervical smears but fall short of discriminating between transient infections which can spontaneously regress and persistent infections, which have a high chance to progress to high-grade squamous intraepithelial lesions. At this point, the PIPAVIR consortium comes in with the proposal to develop and validate a new diagnostic test for progressive infectious diseases that allows detection, by sandwich-ELISA, of HPV E7 proteins in cervical smears, as markers specific for persistent infections with bad prognosis. In addition, it is planned to develop and validate a diagnostic test strip for rapid detection of viral E7 proteins in cervical smears, most appropriate for alternative diagnostic procedures, such as self-sampling, as well as for the use in low-resource settings. As a major innovative feature, both proposed products use as molecular markers virus-encoded proteins closely related to infection-associated pathology, rather than just the presence of viral DNA or any surrogate markers. Based on the potential of the technology to meet a real clinical need, it can be anticipated that the ability of the participating SME partners to provide and market such superior diagnostic tools will create great business opportunities.

Krumbholz A.,Jena University Hospital | Mohn U.,Mikrogen GmbH | Lange J.,Jena University Hospital | Motz M.,Mikrogen GmbH | And 6 more authors.
Medical Microbiology and Immunology | Year: 2012

Due to the increasing number of non-travel-associated hepatitis E virus (HEV) infections observed in several industrialised countries including Germany, there is a substantial interest in the characterisation of risk factors and transmission routes relevant to autochthonous HEV infections. Autochthonous cases are believed to be the result of a zoonotic HEV transmission from pigs, wild boars and deer. Recently, a high prevalence of HEV-specific antibodies in the German domestic pig population has been demonstrated. Thus, one may assume a higher prevalence of HEV-specific antibodies in humans with occupational exposure to pigs. In this study, sera obtained from 24 slaughterers, 14 meat inspectors, 46 pig farmers and 22 veterinarians were tested for the presence of HEV-specific antibodies using a line immunoassay. For comparison, sera obtained from 116 age- and gender-matched blood donors were also included. Twenty eight per cent (28.3%; 30/106) of the swine-exposed humans and 15.5% (18/116) of the blood donors without contact to pigs exhibited IgG-antibodies determined as reactive (i.e. borderline or positive) against HEV. Thus, an increased risk of HEV infection in humans occupationally exposed to pigs and particularly for slaughterers (41.7%; 10/24) was demonstrated. © Springer-Verlag 2011.

Bohm B.,Albert Ludwigs University of Freiburg | Heinzelmann S.,Albert Ludwigs University of Freiburg | Motz M.,Mikrogen GmbH | Bauer G.,Albert Ludwigs University of Freiburg
Biological Chemistry | Year: 2015

Oncogenic transformation is dependent on activated membrane-associated NADPH oxidase (NOX). However, the resultant extracellular superoxide anions are also driving the NO/peroxynitrite and the HOCl pathway, which eliminates NOX-expressing transformed cells through selective apoptosis induction. Tumor progression is dependent on dominant interference with intercellular apoptosis-inducing ROS signaling through membrane-associated catalase, which decomposes H2O2 and peroxynitrite and oxidizes NO. Particularly, the decomposition of extracellular peroxynitrite strictly requires membrane-associated catalase. We utilized small interfering RNA (siRNA)-mediated knockdown of catalase and neutralizing antibodies directed against the enzyme in combination with challenging H2O2 or peroxynitrite to determine activity and localization of catalase in cells from three distinct steps of multistage oncogenesis. Nontransformed cells did not generate extracellular superoxide anions and only showed intracellular catalase activity. Transformed cells showed superoxide anion-dependent intercellular apoptosis-inducing ROS signaling in the presence of suboptimal catalase activity in their membrane. Tumor cells exhibited tight control of intercellular apoptosis-inducing ROS signaling through a high local concentration of membrane-associated catalase. These data demonstrate that translocation of catalase to the outside of the cell membrane is already associated with the transformation step. A strong local increase in the concentration of membrane-associated catalase is achieved during tumor progression and is controlled by tumor cell-derived H2O2 and by transglutaminase. © 2015 by De Gruyter.

Bauer G.,Albert Ludwigs University of Freiburg | Motz M.,Mikrogen GmbH
Anticancer Research | Year: 2016

Neutralizing single-domain antibodies directed towards catalase or superoxide dismutase (SOD) caused efficient reactivation of intercellular reactive oxygen species/reactive nitrogen species (ROS/RNS)-dependent apoptosis-inducing signaling specifically in human tumor cells. Single-domain antibodies targeted tumor cell-specific membrane-associated SOD and catalase, but not the corresponding intracellular enzymes. They were shown to be about 200-fold more effective than corresponding classical recombinant antigen-binding fragments and more than four log steps more efficient than monoclonal antibodies. Combined addition of single-domain antibodies against catalase and SOD caused a remarkable synergistic effect. Proof-of-concept experiments in immunocompromised mice using human tumor xenografts and single-domain antibodies directed towards SOD showed an inhibition of tumor growth. Neutralizing single-domain antibodies directed to catalase and SOD also caused a very strong synergistic effect with the established chemotherapeutic agent taxol, indicating an overlap of signaling pathways. This effect might also be useful in order to avoid unwanted side-effects and to drastically lower the costs for taxol-based therapy.

Bredl S.,Redbiotec | Bredl S.,University of Regensburg | Plentz A.,University of Regensburg | Wenzel J.J.,University of Regensburg | And 3 more authors.
Journal of Clinical Virology | Year: 2011

Background: Acute parvovirus B19 (B19V) infection is characterized by high-level viremia. Antibodies against the capsid proteins VP1 and VP2 may complex with B19V-particles thereby becoming undetectable in diagnostic tests. Objectives: We intended to obtain data on the frequency of false-negative serology in acute B19V-infection. Study design: 129 plasma or serum samples of healthy blood donors and of patients with suspected B19V-infection were analyzed for B19V-DNA by qPCR and VP1/VP2-specific IgG and IgM by ELISA. Eleven of these samples were derived from four pregnant women with previous contact to B19V-infected individuals. Using acidic conditions virus/antibody-complexes were disrupted and detected by WesternLine and ELISA. Results: 83/118 samples were derived from acutely infected individuals displaying viremia (10 3-10 12geq/mL). In 24/83 viremic samples (28.9%) VP1/VP2-specific IgM and IgG were undetectable in ELISA, but could be demonstrated to be complexed with B19V-particles. Each 7/83 (8.4%) was IgM-positive/IgG-negative and IgM-negative/IgG-positive, in 45/83 samples (54.2%) IgG and IgM could be detected. 35 samples did not contain B19V-DNA; five of these were from seronegative persons. Analyzing consecutive sera derived from four pregnant women, B19V-DNA was demonstrated in 10/11 samples, B19V-specific IgG- and IgM-antibodies were detectable in 10/11 and 4/11 samples, respectively. In 2/4 women seroconversion was observed, but IgM was not detected in 50% of the samples. B19V-specific IgG but not IgM was detectable in 2/4 women. Conclusion: Acute B19V-infection cannot be diagnosed by exclusive analysis of B19V-specific antibodies. Only the combination of assays for detection of B19V-DNA and antibodies enables correct serodiagnosis. © 2011 Elsevier B.V.

Driven by a small number of players, the global market for Hepatitis E Diagnostic Tests exhibits a highly competitive landscape, finds a new report by Transparency Market Research (TMR). With a share of nearly 31%, Beijing Wantai Biological Pharmacy led the global market in 2015 and was distantly followed by Mikrogen. Competitive pricing strategy among the leading players is expected to intensify the rivalry within the market in the forthcoming years. According to the research report, the global hepatitis E diagnostic tests market stood at US$43.7 mn in 2015. Expanding at a CAGR of 3.80% during the period from 2016 to 2024, the opportunity in this market is likely to increase to US$60.4 mn by the end of the forecast period. Being the primary test for the detection of hepatitis E, the kits used for ELISA HEV IgM tests have been the most valued diagnostic kits in this market in the recent past and will continue to be so due to the same reason. Hepatitis E Hyperendemicity in Asian Economies to Ensure Dominance of Asia Pacific Region The research report has also analyzed the worldwide market for hepatitis E diagnostic tests on the basis of geography. According to the study, Europe, Asia Pacific, Latin America, North America, and the Middle East and Africa have surfaced as the main regional markets for hepatitis E diagnostic tests across the world. Due to the hyperendemicity of hepatitis E in various Asian economies, such as Nepal, Pakistan, India, Vietnam, Bangladesh, Bhutan, Burma, Kazakhstan, and Thailand, Asia Pacific has surfaced as the leading regional market for hepatitis E diagnostic tests and is expected to remain so over the forecast period. The Asia Pacific market for hepatitis E diagnostic tests is likely to acquire more than 48% of the overall market by 2024. Besides, the Middle East and Africa is also projected to witness a significant rise in the market for the hepatitis E diagnostic tests over the next few years due to the increasing prevalence of hepatitis E in various countries in this region, such as Kenya, Morocco, Uganda, and Nigeria, owing to lack of safe drinking water and poor sanitation facilities. "The growth of the global market for hepatitis E is directly proportional to the prevalence of hepatitis E across the world," says the author of this study. As per the WHO, nearly 20 million people suffer from HEV infections every year, worldwide, among which around 3.3 million are symptomatic cases. With the increasing scarcity of potable water and the lack of sanitation, the cases of hepatitis E infection is likely to increase considerably over the forthcoming years and will result in a substantial rise in the need for hepatitis E diagnostic test in the near future, states the research report. Although the worldwide market for hepatitis E diagnostic tests currently looks teeming with opportunity, it may face a severe challenge over the years to come from the rising incidence of asymptomatic diseases, which are difficult to diagnose. The low level of awareness among consumers is also expected to emerge as a restraining factor for the growth of this market in the long run, notes the study. The study presented here is based on a report by Transparency Market Research (TMR) titled "Hepatitis E Diagnostic Tests Market - Global Industry Analysis, Size, Share, Volume, Growth, Trends, and Forecast 2016 - 2024." The Hepatitis E Diagnostic Tests Market has been segmented as follows: Transparency Market Research (TMR) is a U.S. based provider of syndicated research, customized research, and consulting services. TMR's global and regional market intelligence coverage includes industries such as pharmaceutical, chemicals and materials, technology and media, food and beverages, and consumer goods, among others. Each TMR research report provides clients with a 360-degree view of the market with statistical forecasts, competitive landscape, detailed segmentation, key trends, and strategic recommendations.

Devices are disclosed for serologically detecting an infection with human-pathogenic Yersinia ssp, wherein said device comprises at least one antigen selected from the group of antigens consisting of the following group: YopD, YopH, YopM, YopE, V-AG and YopN or a fragment of one of said antigens having at least eight consecutive amino acids and furthermore one of two proteins selected from MyfA and PsaA or fragments of one of said two proteins having at least eight consecutive amino acids.

The present invention relates to a diagnostic test for the detection of an E7 protein of a human papilloma virus in a biological sample wherein a sandwich ELISA as capture antibody at least two different rabbit monoclonal antibodies which bind to at least two different epitopes are used and as detection antibody at least two different polyclonal anti E7 antibodies are used.

Mikrogen GmbH | Date: 2012-11-06

Diagnostic agents, namely, reagents and diagnostic preparations for scientific purposes; biochemical agents and preparations, namely, reagents, for scientific purposes, in particular recombinantly produced proteins and peptides; chemical and biochemical reagents and genetic identity tests comprised of reagents for the identification of DNA by means of PCR technology and hybridization. Diagnostic agents, for medical and pharmaceutical purposes, namely, medical diagnostic reagents and radioactive pharmaceutical preparations for in vivo diagnostic use; biochemical agents and preparations for pharmaceutical purposes, namely, pharmaceuticals for use in diagnosing bacterial and viral infectious diseases and autoimmune diseases; diagnostic agents for medical purposes, namely, recombinantly or synthetically produced antigens for medical, in particular diagnostic purposes; diagnostic agents for medical purposes, namely, lysates of microorganisms, in particular preparations of components of microorganisms usable for diagnostic purposes; diagnostic agents for carrying out serologic tests for medical purposes; biochemical preparations for carrying out verification tests for medical purposes, namely, diagnosis of bacterial and viral infectious diseases and autoimmune diseases ; diagnostic preparations for medical use, namely, diagnostic preparations for carrying out western blot tests for medical purposes; diagnostic preparations for medical use, namely, diagnostic preparations for carrying out enzyme immune tests for medical purposes; diagnostic reagents for serologic test of infections for medical purposes. Services of a medical, bacteriological and biochemical laboratory, in particular chemical synthesis of oligonucleotides; scientific analysis regarding reagents and probes for the identification of DNA by means of PCR technology and hybridization; research and development services in the field of bacteriology, cytology, antibody technology, chemistry, immunology and gene expression systems, in particular regarding cloning, expression and purification of proteins and antigens for third parties; biochemical research and development for recombinant production of partially purified proteins of microorganisms.

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