Advanced Diagnostics and Analytics
The diagnostic value chain
The key to effective therapeutic interventions is often through early diagnosis, and this has been greatly advanced in recent years through innovations in molecular diagnostics and personalised medicine. Austria has been at the forefront of these developments, from the discovery of biomarkers through to the manufacture of equipment for IVD diagnostics and the actual handling of specimens for analysis. The development of accurate diagnostic tests can save lives in finding otherwise undetected illnesses early enough to make a difference.
Biomarkers
Biocrates Life Sciences has established itself as a leading company in the field of diagnostic biomarker research. The company identifies and quantifies endogenous metabolites in body fluids and tissue samples and further develops them into useful biomarkers. So far, a pipeline of metabolic biomarkers for cancer but also for diabetes and kidney diseases has been set up. Biocrates’ experience in biomarker discovery has resulted in the development of the first mass-spectrometry-based metabolomics kits, AbsoluteIDQ® p150 Kit and AbsoluteIDQ® p180 Kit. The kit pipeline is being extended by additional research kits. Beside its own biomarker pipeline the company is supporting other research organisations in the development of their biomarker panels.
The key to the discovery of new disease biomarkers is the careful gathering and studying of biological materials derived from patients with known medical conditions. Austria has been at the forefront of this “biobanking” in Europe. For example, the Christian Doppler Laboratory for Biospecimen Research and Biobanking Technologies at the Medical University of Graz is working in collaboration with QIAGEN on new approaches and technologies in biobanking and biospecimen research. Particularly, the collaboration focuses on providing solutions to exploit the opportunities of next generation sequencing and metabolomics in the context of molecular pathology. The technologies developed and knowledge generated will also provide the rationale for a series of new diagnostics and therapeutic approaches.
Of particular note is the COMET-funded project BioPersMed – “biomarkers for personalised medicine” – at the Medical University of Graz which is now in its second year. Researchers and the Biobank at the university are working in conjunction with industry focusing on finding biomarkers in common metabolic diseases such as cardiovascular, metabolic, bone and liver diseases. Among others, early results in paediatric type I diabetes have shown some very interesting data comparing immune response to vitamin D from healthy volunteers and children with type I diabetes. This has significant implications for targeted “soft” interventional treatments in children.
The diagnostic value chain
Once a biomarker has been identified, there are other technologies and services that have to be applied to make them into products with laboratory or clinical utility. Austria has many companies supporting the analytical process and providing technologies to support every stage of the diagnostic value chain.
One of Austria’s oldest and best known life science companies is Greiner Bio-One, a world-market leader in the field of biotechnology, diagnostics and pharmaceuticals with a distribution network in more than 100 countries and about 1700 employees. Greiner Bio-One is a global player in plastics and laboratory supplies with special products for blood, urine and specimen collection. These products are important in pre-analytics where the collection, labelling, transport and storage of blood, urine or saliva forms the first part of the value chain in the diagnostic process.
Greiner Bio-One has been working in collaboration with the software-programming company Servolabs and the Elisabethinen Hospital in Linz to develop a dedicated tracking system to ensure the security of individual blood samples throughout the pre-analytical process. The tracking system is able to securely capture and process patient and specimen data in combination with bar-coded VACUETTE® sampling tubes. The result saves time and money through a reduced need for cumbersome paperwork and a consequent reduction in errors and greater safety through a more efficient and fault free communication between labs and hospital units.
Another part of the value chain where Austria has a pivotal role to play is in the development of innovative diagnostic chip design. Lambda, a subsidiary of Greiner Bio-One, offers DNA-chip technology with a focus on detection and diagnosis of bacteria and viruses. As well as the production of ready-to-use-kits, Lambda also has interests in developing its chips for use in food diagnostics and quality control products for the pharmaceutical industry.
Anagnostics is also a pioneer in the field of innovative diagnostic chip design with its proprietary hybcell technology for use in multiplex clinical and medical research diagnostics. The aim is to provide solutions for unmet needs especially in the fields of drugs of abuse screening, severe infections and diagnostics in the field of oncology. The hyborg analysis system that the technology is based on is a fully integrated and automated microarray based DNA and protein assay.
VBC Genomics Bioscience Research was founded in 1999 as a spin-off of the University of Vienna and as part of the Vienna Biocentre. The company’s core activities used to consist of five synergetic research areas of life science and diagnostics, genomic services, proteomics, biochip-technology and bioinformatics. After an acquisition by Phadia, the company was renamed to Phadia Austria and VBC Genomics’ innovative biochip technology was combined with cutting-edge research in molecular allergology. Their proprietary product ImmunoCAP ISAC® is the most advanced in vitro diagnostic test for the measurement of specific IgE antibodies to allergen components. The Phadia group was recently acquired by Thermo Fisher Scientific.
TissueGnostics is an EN ISO 13485:2003 certified Austrian medtech company with branch offices in Romania and USA, focused on high-end medical image analysis of tissue, cell and blood samples. TissueGnostics is on the cutting edge of science and technology. The company provides a new generation of analysis tools for research and medical diagnosis and is the first manufacturer to offer a quantitative analysis of tissue sections and cell cultures by automated microscopy and state-of-the-art image analysis (including machine-learning techniques). The company has a strong network within the industry and academia as well as strong Intellectual Property Rights covered by worldwide patents.
VASEMA is an innovative high-tech medical device company that develops and manufactures precision instruments for the detection and diagnosis of skin diseases. The earlier changes in the skin can be detected, the better the chances are for the patient’s recovery. The company is a certified manufacturer of high-quality products based on its patented nanosensor technology which stands for reliability, security and speed. VASEMA is characterised by outstanding innovation, top quality, direct customer relationships and strong personal commitment.
Right down the value chain, Austria is innovating in diagnostics and it is the interplay and business cooperation between these companies and some of the leading global diagnostic companies that gives Austria such a pivotal position in this industry.
Molecular diagnostics
An accurate and clear diagnosis forms the basis for the state-of-the art treatment of disease, and advanced molecular diagnostics can give a clear window onto biomarkers and disease processes that enable accurate decisions to be made by the doctor. Austrian companies are producing world-leading analytical devices. In fact, in the near future special medical devices developed in Austria will even be used for the first human explorations of the planet Mars.
The German pharmaceutical company B. Braun is a pioneer in molecular diagnostics and recently opened a development office in order to test a new glucose sensor. The optical glucose sensor is intended to reduce morbidity and mortality in intensive care units and shorten ICU lengths of stay. The strict blood glucose monitoring enabled by the sensor in combination with an insulin treatment protocol makes this possible. High blood glucose is not just limited to people with a history of diabetes. Hyperglycaemia and insulin resistance are in fact very common in critically ill patients.
Another company pushing the boundaries in this field is Ionimed, a medical device company with expertise in the detection and quantification of trace amounts of volatile organic compounds. Due to this specific knowledge, Ionimed has constructed analytical instruments based on the technique of proton-transfer-reaction mass spectrometry (PTR-MS) as well as the respective gas calibration equipment. This know-how is desired by the pharmaceutical industry for real time monitoring of fermentation processes.
Lexogen, a biotech start-up based in Vienna, is developing a set of complementary technologies that present a breakthrough in the level of detail that RNA expression can be profiled. Lexogen’s proprietary SQUARE technology presents a unique, hypothesis-free approach to reduce the complexity of the transcriptome and empowers Next Generation Sequencing technologies to sequence and quantify all splice variants in which genes are expressed. Lexogen’s SQUARE technology will provide unprecedented insight in molecular pathways.
