Company News: Agena Bioscience Launches High-Throughput, Low-Cost SARS-CoV-2 Detection Panel in Europe with CE-IVD Marking
Agena Bioscience, a global provider of low cost and high-throughput molecular testing solutions, today announced that it has obtained CE-IVD marking for its SARS-CoV-2 Panel, an in vitro diagnostic test for the qualitative detection of the SARS-CoV-2 coronavirus that causes COVID-19.
Patients suffering from the autoimmune disease systemic lupus erythematosus (SLE) develop autoantibodies to chromatin and often to neutrophil proteins as well. As immune complexes of these antibodies can be deposited in kidneys, they contribute to the frequent and dangerous organ manifestation of lupus nephritis.
Recent studies suggest that neutrophil extracellular traps (NETs) might act as a source of autoantigens. NETs consist of chromatin as well as granule proteins and play an important role in immune defense after their release from neutrophils to sites of infection. Degradation of NETs is mainly promoted by DNase1 digestion which is impaired in a subset of SLE patients. A strong correlation between NET degradation status and lupus nephritis, e.g. glomerulonephritis, has been shown and therefore offers a new diagnostic method for detecting an increased risk of SLE patients to develop renal manifestations.
Based on these observations, scientists of the German Max Planck Society (MPG) have developed a technology for the assessment of an increased risk in SLE patients for developing renal manifestations – a finding that is not achieved by determination of anti-dsDNA antibody titers.
The technology measures a NET-degradation status upon incubation with a sample of body fluid (e.g. blood or serum) from a SLE patient, whereby a poor NET-degradation corresponds to a higher probability of developing renal manifestations. Protocols for obtaining NETs from healthy donors as well as preparing NETs artificially are provided. Degradation status is assessed by determination of released/present NET-component(s) (e.g. neutrophil elastase) after incubation with a sample from a patient and either by comparison with the results obtained from a healthy donor or a control sample (buffer). Determination of NET-degradation can be achieved by the use of fluorescence spectrometry, ELISA or EIA. An international patent application has been filed.
The technology is available for licensing via Max Planck Innovation.
– Preparation of CE-marking and product launch in Europe in 2012 –
Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced that Dr. Klaus Brinkmann has joined its management team as Director of Sales.
Dr. Klaus Brinkmann is a seasoned executive with extensive commercial expertise in setting-up sales organizations and infrastructures and leading sales teams in very competitive markets. He has an outstanding track record in the commercialization of complex in vitro diagnostics (IVD). His experience covers instrument platforms as well as test kits in the areas of immunology, traditional microbiology and molecular-based infectious disease testing. He joins Curetis from BioRad Laboratories GmbH, where he has been Account Manager Lab Automation. Previously, he held various sales management positions with Becton Dickinson GmbH and Beckman Coulter GmbH. Klaus Brinkmann studied chemistry and holds a doctorate from Justus Liebig University Giessen, Germany.
Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced the opening of its state-of-the-art production facility for disposable Unyvero™ cartridges in Bodelshausen (near Tuebingen, Germany).
The fully automated manufacturing line in a clean room environment is designed to be fully cGMP compliant and offers scalability and flexibility to meet the growing demands of clinical trials and commercialization with the scheduled 2012 EU launch of the Unyvero P50™ pneumonia cartridge.
Initial production capacity is 100,000 p.a. which may be easily expanded to an annual production capacity of 1 mio. cartridges. First product is the Unyvero™ P50 pneumonia cartridge for the identification of 17 pneumonia pathogens and 22 of their clinically most relevant antibiotic resistance markers.
Read more on the Curetis website.