News

Innovation Radar: A Game Changing Technology for Biomolecule Analytics

All biomolecules operate and interact in aqueous solutions, surrounded by a characteristic hydration shell. Virtually any conformational change of a biomolecule, e.g. the formation of a protein-protein complex or the binding of a small molecule, results in a change of the individual hydration shell.

A German company called NanoTemper Technologies has found a way to easily monitor these specific changes in the hydration shell and to derive quantitative information on interactions, conformational changes and macromolecular stability. The beauty of the concept termed Microscale Thermophoresis (MST) lies in its ability to observe and measure various parameters, such as affinities and binding energetics, at conditions which almost fully mirror the native environment of the biomolecules found in cells.

This is of great value, in particular for interactions that are difficult to access with standard methods, like the binding of small molecules or single ions to larger components of the cell, or the interactions of peptides and proteins to membrane receptors, the most important pharmaceutical drug targets.

NanoTemper, a spin-off from the Center of NanoScience (CeNS) at Ludwig-Maximilians-University in Munich (Germany), was founded in 2008. The company is headquartered in Munich and runs a fully owned subsidiary in San Francisco (USA). NanoTemper offers instruments and consumables to customers worldwide. The products provide scientists in basic research with cost-effective access to an enabling technology and allow experiments that have never been possible before. Pharmaceutical and biotech companies can use the technology for faster and better characterization of drug candidates. For more information visit www.nanotemper.de.

 

Pictured below: Monolith NT.115, one of NanoTemper´s Microscale Thermophoresis instruments

Food for Thought: Future Benefit Assessment of Medtech in Germany

Germany´s Law on the Stabilization and Structural Reform of the Statutory Health Insurance (Versorgungsstrukturgesetz) came into effect January 1st, 2012. For medtech companies it is important that the law introduces a novel instrument of the statutory healthcare system’s Joint Federal Committee G-BA for the assessment of innovative medical technologies. This novelty – the so-called “trial provision” for innovative medtech methods – has the advantage of not summarily excluding methods whose benefit is not immediately clear.

Dr Rainer Hess, Chairman of G-BA, in January detailed the plans of G-BA for the assessment of innovative medical technologies: “We are not assessing medicinal products, such as pacemakers or endo-prostheses,” he said during the recent MedInform conference “Versorgungsstrukturgesetz 2012” hosted by BVMed, the German Medical Technology Association. “We are evaluating medical diagnostic and therapeutic procedures in which medical devices may play a role.”

The trial provision, he added, would offer the opportunity to conduct representative studies of novel procedures, if adequate evidence is not available and novel studies are not to be expected.

Hess said G-BA will expect the demonstration of an additional benefit as compared to existing methods.  To determine this additional benefit, G-BA will lay out study requirements in a guideline and assign an institute with conducting the study. Manufacturers will have to contribute financially to the study – otherwise the device can be excluded from reimbursement.

Germany’s Institute for Quality and Efficiency in Healthcare (IQWiG) will then furnish a scientific opinion. Finally, G-BA will host a hearing, including experts, and subsequently make a decision about reimbursement.

Assessment can be demanded by the manufacturers but also from a statutory health insurance company.

Further information can be found at the webseite of BVMed – The German Medical Technology Association

Company News: Curetis AG Initiates Prospective Clinical Trial for Rapid Pneumonia Diagnostics

Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced the start of a prospective clinical trial of its Unyvero™ System and the Unyvero™ P50 Pneumonia Cartridge in the European Union.

The prospective, international, multicenter trial will enroll up to 1,000 hospitalized patients suspected with a lower respiratory tract infection. Patient samples such as sputa, aspirates or bronchial lavages will be pre-processed by the Unyvero™ Lysator and transferred to the Unyvero™ P50 Pneumonia cartridge, which is analyzed by the Unyvero™ Analyzer.

Primary endpoint of the study will be assay performance defined as clinical sensitivity and specificity compared to today’s diagnostics standard of care, microbiology culture. Trial sites include the University Hospital Tuebingen, Germany, the Heart and Diabetes Center Bad Oeynhausen, Germany, the Hospital Clinic of Barcelona in Spain, the Erasme Hospital in Brussels/Belgium, and the University Hospital Jena, Germany. Principal investigator is Prof. Dr. Ingo B. Autenrieth of the University Hospital Tuebingen. Interim topline data are expected for spring 2012.

Innovation Radar: How to Detect Increased Risk for Renal Manifestations in SLE (lupus) patients

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.

 

1 … 157 158 159 … 201