In vitro-diagnostics. in the Capital Region Berlin-Brandenburg

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1 In vitro-diagnostics in the Capital Region Berlin-Brandenburg

2 Germany s Capital Region Berlin-Brandenburg Your Partner for Next Generation in vitro-diagnostics Berlin-Brandenburg covers the full range of the biotech and pharma value chain, from substance and process development to clinical research, production and services. In vitro-diagnostics and bioanalytics in Berlin-Brandenburg means:»» About 20 excellent research institutions focus on the identification of new biomarkers and new platform technologies for diagnostic tools.»» More than 80 small and medium enterprises (SME) as manufacturer or supplier cover a broad spectrum of highly innovative diagnostics. Berlin-Brandenburg develops solutions for next generation in vitro-diagnostics and bioanalytics like sensor-actor-molecules and autonomous biosensors, genome-, proteomeand glycan-based multiplex analytics (microarrayand bead technologies) and metabolomics platforms for new biomarker strategies.»» Berlin-Brandenburg is the place for implementing clinical validation studies. Germany`s most diversified hospital landscape with the Charité Universitätsmedizin Berlin has access to patient cohorts of urban and rural populations of about 180 ethnicities, covering all medical indications. Customers from research and industry may have access to advanced biobanking infrastructures. The Berlin-Brandenburg Center for Molecular Diagnostics and Bioanalytics (ZMDB) is the platform for technology transfer and supports cooperations between science, clinics and industry. The ZMDB is your interface to get access to Berlin-Brandenburg s expertise in in vitro-diagnostics and bioanalytics. Basic Research Applied Research Identification of Biomarkers Genomics/Proteomics/ Glycomics/Metabolomics Validation of Biomarkers Microarrays Lab-on-Chip POCT Biosensors Automation Product Research & Development Production Approval Reimbursement Marketing Clinical Studies Validation of Biomarkers Biobanking Metabiobanking

3 In vitro-diagnostics in Berlin-Brandenburg Selected Companies Berlin Brandenburg 5 1 8sens.biognostic GmbH 2 Alacris Theranostics GmbH 3 ASTRA BIOTECH GmbH 4 ATLAS Biolabs GmbH 5 Attomol GmbH 6 BIOTECON Diagnostics GmbH 7 BioTeZ Berlin-Buch GmbH 8 BST Bio Sensor Technology GmbH 9 caprotec bioanalytics GmbH 10 CellTrend GmbH Chipron GmbH 12 CONGEN Biotechnologie GmbH 13 E.R.D.E.-AAK-Diagnostik GmbH 14 Epigenomics AG 15 Epiontis GmbH 16 FILT Lungen- und Thoraxdiagnostik GmbH 17 GA Generic Assays GmbH 18 GILUPI GmbH 19 GlucoMetrix AG 20 Glycotope GmbH 21 idoc Institute for Telemedicine and Health Communication GmbH & Co. KG 22 in.vent DIAGNOSTICA GmbH 23 Institute Cardiac Diagnostics and Therapy (IKDT GmbH) 24 JPT Peptide Technologies GmbH 25 Labor Berlin Charité Vivantes Services GmbH 26 LGC Genomics GmbH 27 Limetec Biotechnologies GmbH 28 Medipan GmbH 29 Metanomics Health GmbH 30 MicroDiscovery GmbH 31 Minerva Biolabs GmbH 32 peptides&elephants GmbH 33 PolyAn GmbH 34 Proteome Factory AG 35 Provitro GmbH 36 SCIENION AG 37 Seramun Diagnostica GmbH 38 SIFIN Institut für Immunpräparate und Nährmedien GmbH Berlin 39 Signature Diagnostics AG 40 Source BioScience imagenes GmbH 41 STRATEC Molecular GmbH 42 Strix Diagnostics GmbH 43 Surflay Nanotec GmbH 44 TIB MOLBIOL Syntheselabor GmbH 45 Zentrum für molekulare Onkologie GmbH

4 In vitro-diagnostics in Berlin-Brandenburg Research Institutions Berlin Brandenburg 19 1 BAM Federal Institute for Materials Research and Testing 2 Beuth Hochschule für Technik Berlin University of Applied Sciences 3 DIfE (German Institute of Human Nutrition) Potsdam Rehbrücke 4 Charité - Universitätsmedizin Berlin 5 Deutsches Rheuma- Forschungszentrum Berlin 6 Fraunhofer Institute for Telecommunications Heinrich Hertz Institute 7 Fraunhofer Institute for Applied Polymer Research IAP 8 Fraunhofer Institute for Biomedical Engineering IBMT 9 Humboldt University of Berlin 10 IHP GmbH - Innovations for High Performance Microelectronics Leibniz-Institut für Molekulare Pharmakologie (FMP) 12 Max Delbrück Center for Molecular Medicine Berlin-Buch 13 Max Planck Institute for Infection Biology 14 Max Planck Institute for Molecular Genetics 15 Max Planck Institute of Colloids and Interfaces 16 Physikalisch-Technische Bundesanstalt (PTB) 17 Robert Koch Institute (RKI) 18 Technical University of Applied Sciences Wildau 19 University of Applied Sciences Lausitz 20 University of Potsdam

5 In vitro-diagnostics in Berlin-Brandenburg Overview Companies 8sens.biognostic GmbH 1 1 Alacris Theranostics GmbH 1 AptaRes AG 1 ASTRA BIOTECH GmbH ATLAS Biolabs GmbH 1 1 Attomol GmbH BIOTECON Diagnostics GmbH 1 1 BioTeZ Berlin-Buch GmbH 1 1 BST Bio Sensor Technology GmbH caprotec bioanalytics GmbH 1 CellTrend GmbH Chipron GmbH 1 CONGEN Biotechnologie GmbH 1 E.R.D.E.-AAK-Diagnostik GmbH 1 1 Epigenomics AG 1 Epiontis GmbH 1 FILT Lungen- und Thoraxdiagnostik GmbH ifp Institut für Produktqualität GmbH GA Generic Assays GmbH 1 1 GILUPI GmbH 1 1 GlucoMetrix AG Glycotope GmbH 1 idoc Institute for Telemedicine and Health Communication GmbH & Co. KG 1 1 in.vent DIAGNOSTICA GmbH Institute Cardiac Diagnostics and Therapy (IKDT GmbH) 1 1 JPT Peptide Technologies GmbH Labor Berlin Charité Vivantes Services GmbH LGC Genomics GmbH 1 1 Limetec Biotechnologies GmbH Medipan GmbH Metanomics Health GmbH 1 MicroDiscovery GmbH Minerva Biolabs GmbH peptides&elephants GmbH PolyAn GmbH 1 Proteome Factory AG 1 1 Provitro GmbH 1 1 SCIENION AG Seramun Diagnostica GmbH SIFIN Institut für Immunpräparate und Nährmedien GmbH Berlin Signature Diagnostics AG 1 1 Source BioScience imagenes STRATEC Molecular GmbH 1 Strix Diagnostics GmbH 1 1 Surflay Nanotec GmbH Thermo Fisher Scientific B R A H M S GmbH TIB MOLBIOL Syntheselabor GmbH Zentrum für molekulare Onkologie GmbH 1 1 Clinical Chemistry Immunoassay Molecular Diagnostics Hematology Coagulation Microbiology Point of Care Testing others

6 science In vitro-diagnostics in Berlin-Brandenburg Overview Research Institutions Basic Research Identification and Validation of Biomarkers BAM Federal Institute for Materials Research and Testing Charité Universitätsmedizin Berlin DIfE (German Institute of Human Nutrition) Potsdam-Rehbruecke 1 1 Fraunhofer Institute for Telecommunications Heinrich Hertz Institute 1 Fraunhofer Institute for Applied Polymer Research IAP 1 1 Fraunhofer Institute for Biomedical Engineering IBMT 1 1 Humboldt University of Berlin Systems Immunology Lab IHP GmbH Innovations for High Performance Microelectronics 1 Max Delbrück Center for Molecular Medicine Berlin-Buch Max Planck Institute for Molecular Genetics Max Planck Institute of Colloids and interfaces Physikalisch-Technische Bundesanstalt (PTB) 1 1 Technical University of Applied Sciences Wildau University of Applied Sciences Lausitz 1 1 University of Potsdam Assay Development Technology Development others

7 8sens.biognostic GmbH Foundation: 2000 Employees: 10 8sens.biognostic GmbH design, develop and produce in vitro-diagnostica (IVD) up to CE approval. We offer: custom-made development and production of immunochromatographic lateral flow tests and microtiterplate-based assays (ELISAs, etc.) as well as production of antibody conjugates (colloidal gold, latex, dyes etc.) for research and production. Our key business activities also cover novel protein-based macro arrays for multianalyte detection (e. g. panels for heart attack, heart risk and TORCH) as well as adaptable reader systems for easy quantification of rapid test and macro array results. Market Segments Lateral flow assays Reader systems for quantification Development on demand IVD-orientated nanotechnology Rapid tests QuickSens h-fabp, ctni QuickSens CRP, hs-crp Reader system QuickSens Ω100 8sens.biognostic GmbH Robert-Rössle-Straße Berlin Germany Volker Landorff

8 Alacris Theranostics GmbH Foundation: 2008 Employees: 15 The company is based on novel translational medicine/ systems biology technology developed at the Max Planck Institute for Molecular Genetics in Berlin coupled with preferential access to the world s most cost effective sequencing and genotyping technology. The scientific founders are among the world s foremost experts in sequencing technology, systems biology and biomedicine. Alacris Theranostics offers its services internationally in Europe and North America. Cutting-edge next generation sequencing technology Genome, epigenome, and transcriptome sequencing Proprietary technology platform ModCell Identification of diagnostic markers In silico simulations for the study and evaluation of signal pathways relevant for cancer Simulation of drug effects Stratification of cancer patients for their clinical trials and for biomarker discovery Alacris Theranostics GmbH Fabeckstraße Berlin Germany info@alacris.de Dr. Bodo Lange Biomarker discovery Computer modeling for cancer drug validation Non-invasive cancer genome sequencing Partner in the IT Future of Medicine-project within the FET Flagship Initiative - Partner in the OncoTrackproject within the Innovative Medicine Initiative

9 AptaRes AG Foundation: 2002 Employees: 18 AptaRes is a leading biotechnology company providing oligonucleotide aptamers as an alternative to common antibodies. AptaRes is the sole owner of the proprietary Mono- Lex procedure for Aptamer selection and its applications. We offer high resolution bioanalytics and the technology for downstream processing for immunoglobulins using an innovative IgG Fc-specific binder (like protein A). A quality management system ensures transparent, validated and reproducible processes. The bioanalytical service includes high resolution 2D-gel electrophoresis, mass spectrometry, N-terminal Sequencing, functional tests and more. The protocols are custom tailored to validate product identity, quantitate side products, and validate processes as well as binding specificities of antibodies and aptamers. Market Segments Aptamer selection and applications Bioanalytics Aptamers Antibody Purification Protein Identification / Proteomics N-terminal Sequencing (Edman- Sequencing) 2D high Resolution Electrophoresis MALDI-TOF-MS Analytic Structure Validation Host Cell Protein Analysis (HCP-Analysis) AptaRes AG Tempelhofer Weg Berlin Germany Phone Fax info@aptares.de PD Dr. Andreas Kage (CEO) New Aptamer based active agents New Aptamer based applications

10 ASTRA BIOTECH GmbH Foundation: 2009 Astra Biotech GmbH is a quality-focused company with its success founded on dependable science and strong relationships to develop IVD-compliant, CE-labelled in vitrodiagnostic assays for laboratories specialising in multimedical fields or in education. The product range available includes reagents for detecting and calibrating human hormones, genetic diseases, tumour markers, allergens, antibodies, and recombinant proteins. Market Segments IVD Molecular diagnostics Immunoassays Research on brain stroke, heart attack treatment and bone fracture repair Stem cells in treatment of different diseases ELISA, PCR, MICROARRAY-on-a-CHIP Hormonal diagnostics, metabolism, fertility, pre- and neonatal Tumourmarker Anaemia (Ferritin) Allergy (IgE- total and specific), Osteoporosis, thrombosis, sensitivity towards anticoagulants, sensitivity to antidepressants TORCH, HIV, niche diseases Conjugates, calibrators, recombinant proteins, antigens, allergens ASTRA BIOTECH GmbH Im Biotechnologiepark TGZ I Luckenwalde Germany Phone Fax info@astrabiotech.de Anna Fot (Business Manager) Alexandra Ghica-Cantacuzino (International Sales and Marketing)

11 atlasbiolabs ATLAS Biolabs GmbH Foundation: 2006 Employees: 12 ATLAS Biolabs GmbH is a leading provider of complex analyses in molecular genetics including microarray-based genomic services, targeted sequence capture, and next generation sequencing. Market Segments ATLAS Biolabs performs Genome-wide gene expression and SNP analyses Array CGH Comprehensive mutation profiling and other novel NGS applications for academic institutions, pharmaceutical and biotechnological enterprises, as well as for clinicians and registered doctors. The following services are provided by ATLAS Biolabs: Exome enrichment Next generation sequencing Genotyping Expression profiling Whole genome human SNP genotyping Molecular karyotyping Targeted sequence enrichment Raindance sequence enrichment Sample preparation Bioinformatics analysis and project management Methylation Oncocarta ATLAS Biolabs GmbH Friedrichstraße Berlin Germany Phone Fax customer-support@atlas-biolabs.com Prof. Dr. Peter Nürnberg (CEO)

12 Attomol GmbH Foundation: 1997 Employees: 12 Development, production and distribution of IVD-marked diagnostic tests under Attomol brand or OEM Main technologies are protected by 5 patents Direct marketing in Germany Formation of an international distributor network is not yet finished Co-founder of the research community BioResponse e.v.: Market Segments Molecular genetics Molecular diagnostics of pathogens Autoimmunodiagnostics LoopTag real time PCR or DNA-LINA strip tests: Mycobacteria, Bordetella, Borrelia, Mycoplasma Quicktype mutation assays: Thrombophilia, drug metabolism, lactose intolerance etc. Bead Assay: plex Anti-Nuclear-Antibody confirmation Antibody LINA strip tests: Anti-gangliosides, anti phospholipids Technologies: Real time PCR, multiplex technologies, bead assay Applications: Anti-lipid antibody detection, coagulation risk profiling Attomol GmbH Schulweg 6 OT Lipten Bronkow Germany Dr. Werner Lehmann

13 BIOTECON Diagnostics GmbH BIOTECON Diagnostics was founded in 1998 and currently has 51 employees. Our expertise is microbiological service testing of food, beverage and pharmaceutical products. Our company focuses on the development of rapid and innovative detection systems for pathogenic, spoilage and genetically modified organisms based on real time PCR. Besides detection kits, the foodproof product line also includes kits for sample preparation. Today, as an international biotechnology company, biotecon Diagnostics develops, produces and markets these products. We foster a growing network of distributors as well as offer contract development and production to other biotech companies. Due to strong partnerships with food, beverage and pharmaceutical companies, BIOTECON Diagnostics is well aware of their current and future problems. Our experience lends to our strong capability to find new and economically interesting approaches to these existing and upcoming problems both in production and processing. As a small company, we maintain our flexibility to respond to industry concerns quickly and efficiently. Simply put, we provide desired solutions. Fotolia Sven Hoppe BIOTECON Diagnostics GmbH Hermannswerder Potsdam Germany Phone Fax bcd@bc-diagnostics.com Kornelia Berghof-Jäger, Ph. D. (CEO) Alois Schneiderbauer (CBO)

14 BioTeZ Berlin-Buch GmbH Foundation: 1992 Employees: 20 We understand ourselves as partners of biotechnological research, pharmaceutical industry and lab analysis for innovation and quality. Our Business Portfolio: In vitro-diagnostics: e. g. for therapeutical antibodies (TAB) to measure the interaction between TAB and antigens to optimize the treatment Customized synthesis of oligonucleotides (high level services) Support of mycotoxine and vitamin analysis; production of very effective immunoaffinity columns, ELISAs, and toxin and detection conjugates ELISA development, conjugation and labeling of biomolecules, other services Signal/Assay enhancement using our high-tech molecule (Polystrept R), e. g. for lateral flow tests Market Segments IVD development and production Oligonucleotid synthesis Immobilization of molecules ELISA development Feed and food analysis IVD development for the therapeutic antibodies: Enbrel, Avastin, Herceptin Aptamere development BioTeZ Berlin-Buch GmbH Haus 79 Robert-Rössle-Straße Berlin Germany Phone Fax Uwe Ahnert (Member of the board) Outstanding expertise in immunoassays. Own patents and IP: Signal enhancement by Polystrept R (highest immo bilization, outstanding biotin binding capacities) Coating of surfaces for binding biotinylated molecules Unique IVD technology for measuring therapeutic antibodies and antigen in patient serum Immobilisation of biomolecules, e. g. on surfaces and columns

15 Thermo Fisher Scientific, B r a h m s GmbH Thermo Scientific B R A H M S Biomarkers investigate, develop and manufacture novel diagnostic testing procedures to improve early diagnosis and treatment of life threatening diseases. With our high-quality immunodiagnostic tests for sepsis, cardiovascular, pulmonary, and cancer disorders as well as prenatal screening we contribute to the creation of a healthier future to the greatest advantage for medical professionals and patients. In Future simple and economic blood tests will be of great importance for an early detection and successful treatment of diseases. With our Know-How and technologies we are confident to play an active role in this future: Our products provide important information to clinicians and laboratories in more than 65 countries worldwide and support their clinically and economically relevant decisions. On the basis of our completely owned patents and with help of more than 470 employees worldwide Thermo Scientific B R A H M S Biomarkers are leading in specific market places and therapeutic areas. Fully automated KRYPTOR platform with TRACE technology (TRACE = Time-Resolved Amplified Cryptate Emission) Radioimmunoassay Lumineszenzassay Enzymimmunoassay The aim of our basic research is to identify new biomarkers, with support by international cooperations and reputable research institution. Thermo Fisher Scientific B R A H M S GmbH Neuendorfstraße Hennigsdorf Germany Phone Fax info.brahms@thermofisher.com

16 BST Bio Sensor Technology GmbH Foundation: 1991 Employees: approx. 20 BST s history dates back to 1975 when a biosensor research group started at the Berlin Academy of Sciences. Already in 1982 the first European glucose analyzer based on a multi-way glucose biosensor could be launched successfully. Today, BST is market leader in multi-way biosensors in europe and an international operating company in e. g. Asia, Eastern and Western Europe. BST s core competence is the development and production of multi-way biosensors as well as instruments based on these multi-way biosensors for laboratory and POCT applications. In addition to that also all related consumables are developed, produced and marketed by BST. Market Segments POCT diagnosis of glucose and other metabolites based on multi-way biosensors Determination of glucose and other metabolites for clinical chemistry Diagnosis of training state of athletes (lactate analysis) Immobilising of biological recognition elements for usage in diagnostic tools Conception, development and production of: Multi-way biosensors for pmol/l to mmol/l concentrations Instruments based on multi-way biosensors (e. g. GLUKOMETER PRO, LAC PRO, LabTrend) All related consumables for the application of multi-way biosensors Development of potentiometric sensors based on thick film technology Development of minimal invasive glucose system BST Bio Sensor Technology GmbH Buchholzer Straße Berlin Germany Phone Fax info@bst-biosensor.com Dr. Dorothea Zahn (Managing Director)

17 caprotec bioanalytics GmbH Foundation: 2006, start of building up operation in 2008 Employees: 30 caprotec bioanalytics GmbH has developed a ground-breaking, proprietary technology to reduce the complexity of protein mixtures and samples in a targeted and directed manner. caprotec s Capture Compound Mass Spectrometry (CCMS) Technology is based on trifunctional Capture Compounds which enable capturing and isolating proteins based on their functionality CCMS is closing a technology gap between shotgun approaches and pull-down experiments thus addressing an unmet need in the proteomics community The company is commercializing the CCMS technology as kits for research applications and customized Capture Compounds in collaborations with pharmaceutical companies or academic research The focus is on investigating mechanisms of drug action and avoidance of toxicological effects of small molecule drugs Small molecule protein interactions Proteomics Signal transduction Protein kinases Market Segments Drug discovery Proteomics research Capture Compound Mass Spectrometry (CCMS) caprotec bioanalytics GmbH Volmerstraße Berlin Germany Prof. Dr. Hubert Köster caprokits caprobox capromag ImproMed

18 CellTrend GmbH Foundation: 1998 Employees: 8 CellTrend is a certified biotech and diagnostic company. We are offering services and products: Bioassays for drug research and development Cell culture testing Immunogenicity testing Development and production of immunoassays Market Segments Pharma/Biotech/Cosmetics Contract research Contract analysis Contract production Diagnostics CellTrend GmbH Im Biotechnologiepark TGZ Luckenwalde Germany Phone Fax info@celltrend.de Dr. Harald Heidecke (CEO) Mammalian cell culture Immunoassays for research and diagnostic Oncology Cardiovascular diseases Detection of autoantibodies Biomarker development

19 Chipron GmbH Foundation: 2004 Empoyees: <15 Chipron GmbH develops and manufactures DNA macroarrays on polymer supports. The company specializes in assay development for pathogen detection, mutation analysis and food analysis based on its proprietary LCD- Array platform. LCD-Array Kits for HPV typing, kras mutation analysis, detection of fungal or bacterial pathogens and meat species identification are distributed in over 15 countries through a network of distribution partners. Apart from catalogue products Chipron offers customized LCD-Array Kits for particular demands and has developed over 100 of such assays during the last 5 years for industrial and governmental customers. LCD-Array Kits are available as RUO or CE-IVD kits and as OEM products on demand. The minimal requirements for specific lab instrumentation in combination with the simple but comprehensive data readout by the SlideReader software make LCD-Arrays a very robust and economical solution for virtually any laboratory with experience in PCR. Market Segments DNA-based detection assays for human or veterinary pathogens, mutation analysis and food analysis major R&D-Topics DNA/PCR-based quick tests Chipron GmbH Eresburgstraße Berlin Germany Phone Fax info@chipron.com Dr. Volker Heiser heiser@chipron.com PCR-based DNA macroarray kits for pathogen, species and mutation detection Non fluorescent data readout by transmission light scanning and slidereader software Scanner, centrifuge and analysis software

20 CONGEN Biotechnologie GmbH Foundation: 1998 Employees: > 25 CONGEN is specialized in food testing by molecular analysis based on DNA and RNA detection. CONGEN has been a pioneer for over a decade in the development and application of food and feed analysis by real time PCR. Due to our experience in this field, we have a worldwide unmatched competence. We are offering a complete package consisting of: Providing fully accredited service Full range of real time PCR kits for every real time PCR cycler Full range of kits and protocols for sample preparation Real time PCR core reagents (SureMaster and SureCyle ) 1 laboratory 1 Real time PCR training and full support for real time PCR CONGEN Biotechnologie GmbH Robert-Roessle-Straße Berlin Germany Phone Fax info@congen.de Our mission is to serve the food industry with an excellent service and with standardized and reliable test kits in order to realize highest possible food safety and food quality. The full spectrum of our analytical services and products is integrated in our program called: SureFood The SureFood program covers parameters in the application of GMO, allergen, pathogen, animal, plant detection. In all the above application fields CONGEN is an internationally highly recognized and accepted partner for service and real time PCR reagents. The quality of the analyses is assured by using validated methods. CONGEN is accredited according to the EN ISO 17025:2005. All kits are manufactured according to the ISO 9001:2008.

21 E.R.D.E.-AAK-Diagnostik GmbH Foundation: 2005 E.R.D.E.-AAK-Diagnostik GmbH is a diagnostics laboratory that offers the detection of diverse autoantibodies (agaab) in sera. Agonistic autoantibodies (agaab) are directed against cellu lar receptors, particularly those involved in heart function, blood pressure regulation and vascular diseases. AgAAB are frequently detected in patients with: DCM, Myocarditis: agaab against β1-adrenergic receptor and M2-muscerinergic receptor Hypertension: agaab against α1-adrenergic receptor Diabetes type 2: agaab against α1- and AT1-adrenergic receptor Dementia: agaab against α1- and β2-adrenergic receptor To determine the agaab-status different special analysis techniques are used. The prevalence of the different agaab in the different diseases varies from 30 to 90 %. Patients will benefit at a given agaab indication from a personalized, specific medicamentous therapy, which accounts for the agaab induced malfunction of receptors. E.R.D.E.-AAK-Diagnostik GmbH Biomedizinischer Forschungscampus Berlin-Buch Robert-Roessle-Straße Berlin Germany Phone Fax Mobile bimmler@aak-diagnostik.de Mrs. Dipl.-Ing. Marion Bimmler The detection of the agonistic Autoantibodies (agaab) is realized by the following analysis techniques: ELISA (not functional): Detection of a single agaab BIOASSAY (functional): Analysis of all agaab of the sample CALCIUM (functional): Measurement of intracellular calcium transients

22 Epigenomics AG Foundation: 1998 Employees: 82 Epigenomics is a molecular diagnostics company developing and commercializing a pipeline of proprietary products for cancer. The Company s products enable doctors to diagnose cancer earlier and more accurately, leading to improved outcomes for patients. Epigenomics lead product, Epi procolon, is a blood-based test for the early detection of colorectal cancer, which is currently marketed in Europe and is in development for the US. The Company s technology and products have been validated through multiple partnerships with leading global diagnostic companies including Abbott, QIAGEN, Sysmex, and Quest Diagnostics. Epigenomics is an international company with operations in Europe and the US. Epi procolon (marketed in EU; in R&D for US) Epi prolung (marketed in EU) Pipeline with further products for colorectal, lung and prostate cancer Applications in early detection, diagnosis, prognosis, and drug response prediction All products based on proprietary DNA methylation technology Biomarker discovery and validation IVD development for EU and US (ISO 13485) Companion diagnostics R&D for pharma partners DNA methylation technologies Epigenomics AG Kleine Präsidentenstraße Berlin Germany Phone Fax contact@epigenomics.com Dr. Achim Plum (Sen. VP Corporate Development)

23 Epiontis GmbH Foundation: 2003 Employees: Using a novel molecular diagnostics technology, Epiontis offers an immune cell monitoring service as well as customized development of epigenetic assays. Market Segments Quality control for cell therapies Immunomonitoring Epigenetic markers Biomarkers Immunomonitoring service (fee for service) based on epigenetic markers for immune cells Assays for cell therapy quality control (contract development) Discovery of novel epigenetic markers Markers specific for particular cell types Future diagnostic (prognostic, predictive, monitoring) markers Epiontis GmbH Rudower Chaussee Berlin Germany Phone: hoffmueller@epiontis.com Ulrich Hoffmüller (PhD, MBA, Chief Business Officer)

24 FILT Lungen- und Thoraxdiagnostik GmbH Foundation: 1992 Employees: 7 FILT Lung- and Thorax Diagnostic GmbH is developer and manufacturer of products with focus on Exhaled Breath Analysis and airways inflammation diagnostic for treatment management in Asthma and COPD. Our mission in FILT is to use the combined experiences in medical functional and laboratory diagnostic to generate innovative products to improve the early diagnostic of inflammatory diseases and its therapeutic management. Market Segments Pulmonology Asthma COPD POCD of inflammatory diseases Lung function diagnostic, specialized in fractionated breath collection and measurement of flows, volumes, pressures, gases and biomarkers for analytical evaluation of inflammatory diseases ECoScreen 2 (EBC Collector F) ECoCheck (EBC Analyser for H 2 O 2, ph, Lactat) FILT Lungen- und Thoraxdiagnostik GmbH Robert-Rössle-Straße Berlin Germany Phone Fax info@filt.de

25 GA Generic Assays GmbH Developing, manufacturing and distributing in vitrodiagnostic assays in the field of systemic autoimmunity like rheumatic diseases, autoimmune hepatitis, autoimmune neuropathies, vasculitis, autoimmune kidney diseases, gastroenterology and antiphospholipid syndrome (APS) Market leader for anti-asialoglycoprotein receptor ELISA (anti-asgpr) (autoimmune hepatitis) Inventor and market leader for APS antibody profiling by immunodot Inventor and market leader for anti-glycoprotein 2 ELISA (GP2) a new serological marker for Crohn s disease Manufacturing cell-based immunofluorescence assays like HEp2 cells, ANCA and Crithidia luciliae cells Operating worldwide New diagnostic markers for autoimmune neuropathies New diagnostic marker for gastroenterology Market Segments In vitro-diagnostics IFA (HEp2 cells, ANCA, Crithidia luciliae cells and tissue sections) ELISA Immunodot Rapid tests Latex tests GA Generic Assays GmbH Ludwig-Erhard-Ring Dahlewitz/Berlin Germany Phone Fax info@genericassays.com Dr. Christina Fritz (Head of Scientific Marketing)

26 GILUPI GmbH Foundation: 2006 Employees: 18 Several collaborations with various national and international medical universities International company with operations in Europe and the US Several positive ethical votes for clinical trials Proof of concept in vivo Awarded for a grant Medizintechnik Innovationswettbewerb 2007 of the BMBF Market Segments The inventions of the GILUPI GmbH are in the market area of molecular diagnostics. In the prenatal sector the market for screening for trisomy 21 is about 2,5 billion EURO. In the field of cancer for isolating rare tumorcells the market is about 1 billion EURO. GILUPI GmbH is developing, marketing, and selling innovative new nanotechnology-based medical devices to detect and monitor circulating rare blood cells, with a strong focus on the prenatal diagnostic and cancer diagnostic market One application of the new nanodetector device is in the area of prenatal diagnosis, e. g. for analysis of chromosomal aberrations such as that found in Down syndrome Another application is focusing on detecting and enriching rare circulating tumor cells (CTC) from the peripheral blood of cancer patients as markers of disease recurrence and efficacy of systemic cancer treatment Development of the functionalized structured medical wire (FSMW) Biomarker discovery and validation Development of antibodies GILUPI GmbH Am Mühlenberg Potsdam Germany Phone Inga Kliem inga.kliem@gilupi.com Bild: Michael Kempf (fotolia.com)

27 GlucoMetrix AG GlucoMetrix AG was founded in It has 3 major subsidiaries that concentrate on different aspects of enhancing the quality of life for people suffering from diabetes. GlucoMetrix NIB GmbH develops medical devices for measuring blood sugar non-invasively, i. e. without puncturing the skin. GlucoMetrix PVS GmbH develops a new production method for insulin which promises a purer insulin with less side effects. GlucoMetrix Pharma VV GmbH develops, manufactures and markets medicinal products related to wound healing. These are particularly suited for diabetic wounds. Development of expression platforms for biomedical products Development of downstream purification methods BIOSept line of wound treatment products Opto-acoustical device to measure blood sugar non invasively (in collaboration with ETH Zurich) Immunological assay to determine glycated serum proteins (POC-assay; in collaboration with FHI BMT) Genetic predisposition for diabetes mellitus Cost-effective production methods for human insulin GlucoMetrix AG Am Mühlenberg Potsdam Germany info@glucometrix.de P.P. Schikora (CEO)

28 Glycotope GmbH Foundation: 2001 Employees: 75 GLYCOTOPE is a leading biopharmaceutical company in the fields of glycomics and immunotherapeutics and one of the rare full service providers in the development of biologics. For proprietary and customers drug development programs Glycotope has established a business unit to perform immunomonitoring of clinical samples. Offered also as a stand-alone service to support clinical studies, the pharmacokinetic and dynamic characteristics of biotherapeutics and the immune status of patients are determined according to the GCLP guidelines. A variety of kits for quantitative characterization of the cellular immune status and responses is provided by Glycotope-Biotechnology. The kits are used by lab physicians, clinical research organisations and pharmaceutical R&D departments to better understand the activity of a number of immune cells that are relevant in a variety of diseases Design and conduct of immunomonitoring assays to support clinical development Diagnostic test kits based on flow cytometry procedures to measure various cell functions for functional characterisation of cellular immune response, T-cell analysis and characterisation of haematological relevant autoimmune diseases Glycotope GmbH Robert-Roessle-Straße Berlin Germany Phone Fax info@glycotope.com Dr. Hans Baumeister (Associate Director Clinical Immunomonitoring) Continuous development of project specific immunomonitoring assays

29 idoc Institute for Telemedicine and Health Communication GmbH & Co. KG Founded 2004 idoc provides innovative solutions within the fields of telemedicine. The institute combines medical expertise with professional IT and communication management. Market Segments 1telemedicine 1 1telesomnology 1 1telemonitoring 1 1healthcare 1 networks Dementia care Telemedical screening for sleep apnea Telemedical monitoring for diabetes, metabolic syndrom Telemedical data exchange application Telemedical network for multicenter studies Telemedical care support for dementia idoc Institute for Telemedicine and Health Communication GmbH & Co. KG Posthofstraße Potsdam Germany Prof. Nikolaus Boehning 1telemedicine 1 1Prevention 1 Comprehensive medical services

30 ifp Institut für Produktqualität GmbH Founded 2004 Employees: 100 ifp Institut für Produktqualität GmbH is an independent competence centre for food, feed and pharmaceutical analytics, offering a complete range of services and diagnostic products. The combination of expert staff, state-of-the-art laboratory equipment and food diagnostics specifically developed and produced by ifp guarantees high-quality analyses and competent service. Several of ifp s innovative product lines are being successfully distributed worldwide by renowned cooperation partners. Microbiological test kits for the microtiter plate based determination of all water-soluble vitamins in food, pharmaceuticals and human serum Real-time PCR kits for the detection of food pathogens, GMO, allergens, plant and animal species ifp Institut für Produktqualität GmbH Teltowkanalstraße Berlin Germany Phone Fax info@produktqualitaet.com Immunological assays for the rapid on-site detection and quantitative determination of food allergens Microtiter plate based enzymatic test kits for the photometric determination of sugars, organic acids and other metabolites in food Development of improved bioanalytical methods for food testing purposes 1 Strong involvement in funded research projects

31 in.vent DIAGNOSTICA GmbH Your Service Provider for Human Diagnostics Biomaterials of human origin Enhanced biobanking Protein chemistry Contract-based development of proteins and diagnostic tests Clinical studies and CE marking procedures for IVD Market Segments in.vent supplies you with Clinically defined sera and plasma with a worldwide unique variety of matrices Clinically defined human biomaterials like synovial fluid, CSF, etc. Stool, faecal samples Various tissues A great variety of proteins Services in development and manufacturing of diagnostic tests in.vent meets your individual requirements for the complete value chain which involves the areas of R&D, production and quality control with a strictly emphasis on reliability, quality and adherence to schedules. in.vent s procurement of human biomaterial is always strictly oriented towards individual projects as well as highest ethical standards and superior quality. All materials are procured exactly with the information you need and on your specific demand. in.vent s enhanced biobanking serves you with clinically characterized human biomaterials that match exactly your needs to build your customized biobank. in.vent s newest products are the execution of the laboratory part of clinical studies and of CE marking procedures. in.vent DIAGNOSTICA GmbH Neuendorfstraße Hennigsdorf Germany Phone Dr. J.-M. Hollidt (Managing Director) jm.hollidt@inventdiagnostica.de We would be delighted finding solutions that fit you.

32 Institute Cardiac Diagnostics and Therapy (IKDT GmbH) Foundation: 2002 Employees: 8 IKDT is a leading laboratory worldwide in differential diagnostics of viral infections and inflammation of heart muscle tissue following the international recommendations. Three main topics will be covered for routine diagnostics: Histology Immunohistochemistry and Molecular virology IKDT is the only cardiological laboratory performing molecular diagnostics of endomyocardial biopsies in Germany which is accredited by College of American Pathologists (CAP) according to FDA guidelines. Customers for our biopsy diagnostics are hospital-affiliated institutions or private doctor offices. By its platform Innovative Diagnostics IKDT lab as one of the first service providers in Europe offers for customers the prompt access to two innovative research technologies and Taqman Low-Density-Arrays (Applied Biosystems) for gene expression studies or microrna profiling, and bead-based Luminex technology for multiplex measurement of cytokine and immunological profiles. Market Segments Molecular diagnostics and research in cardiology MicroRNA profiling in myocardial tissue and peripheral blood Gene expression studies in cardiac patients Autoantibodies in cardiac patients Mutation screening in patients with cardiomyopathy Institute Cardiac Diagnostics and Therapy (IKDT GmbH) Moltkestraße Berlin Germany info@ikdt.com Dirk Lassner, PhD (Managing Director) Services provided: Routine differential diagnostics of endomyocardial biopsies on cardiomyopathies Molecular diagnostic service

33 JPT Peptide Technologies GmbH Foundation: 2004 Employees: 45 Offices: Berlin, Boston, Brussels Collaborations: NIH, Duke University, Harvard Medical School (USA), Karolinska Institutes (Sweden), BioNTech AG (Germany) JPT Peptide Technologies (JPT) is an ISO 9001:2008 certified and GCLP audited global supplier and development partner for innovative peptide related immune monitoring tools, molecular diagnostics and biomarkers. JPT has developed several high-content peptide technologies that allow proteome spanning and multiplexed discovery, validation, quantification of biomarkers as well as monitoring humoral and cellular immune responses in disease progression and under therapeutic invention. Seromarker discovery, validation and quantification Development of diagnostic tools for immune monitoring and patient stratification Peptide discovery, qualification and optimization Market Segments Molecular and immune diagnostics Biomarker discovery and validation Vaccine and immunotherapy development PepStar TM Peptide microarray platform for seromarker discovery and immune monitoring PepSpot TM Ultra high-throughput peptide synthesis approach for proteome wide T-cell epitope discovery PepMix TM Peptide pool platform for profiling cellular immune responses SpikeTides TM Small scale peptide technique for biomarker quantification JPT Peptide Technologies GmbH Volmerstraße Berlin Germany Phone Fax info@jpt.com

34 Labor Berlin Charité Vivantes Services GmbH Foundation: 20 The company is the service subsidiary of Europe s largest hospital laboratory for clinical pathology and offers complete solutions for any kind of testing for the ivd industry, CROs, the pharmaceutical industry, life science companies and research facilities. Labor Berlin performs > 20 Mio analyses in clinical pathology per year; it is the exclusive laboratory partner of Charité Universitätsmedizin Berlin and the Vivantes Network for Health and provides the diagnostics for approximately in-house patients a day and over out-patients per year. Very broad portfolio of routine diagnostic testing Individual patient services (health monitoring) Testing of new preclinical diagnostics systems (prototypes) High throughput testing under routine conditions of novel diagnostic platforms Co-development of new biomarkers with industrial partners Validation of new bioassays for ivd industry Design, realization and analysis of clinical studies for CROs, pharmaceutical industry, life science companies and research facilities Field tests of telemedical IT solutions Labor Berlin Charité Vivantes Services GmbH Augustenburger Platz Berlin Germany Dr. Andreas Weimann andreas.weimann@laborberlin.com Florian Kainzinger florian.kainzinger@laborberlin.com Co-developing and establishing a fully automated platform for microbiological pathology Data collection on preanalytical systems Co-developing and establishing a routine tele haematological IT solution for linking 12 hospitals in Berlin

35 LGC Genomics GmbH Foundation: 1993 as AGOWA LGC Group acquires AGOWA in 2005 Rebranded and established in April 2010 as LGC Genomics Number of employees: 50 A division of the LGC Group, LGC Genomics delivers high quality services and products for DNA and genetic analysis and sample preparation including: Next generation sequencing DNA sequencing and library construction Nucleic acid extraction services DNA extraction products pharmacogenetics and diagnostic services. LGC is an international science-based company and market leader in analytical, forensic and diagnostic services and reference standards. Market Segments Pharmaceutical and biotechnical companies Private and public research organisations Medical institutions Nucleic acid preparation: Nucleic acid extraction service (DNA, RNA) Kits for nucleic acid preparation (medium/high throughput) LGC Genomics GmbH Ostendstraße Berlin Germany Phone Fax service@lgcgenomics.com Dr. Steffen Krüger (Managing Director) Werner von Heimann (European Sales and Marketing Manager) Genomic services: Next generation sequencing (Roche/454 and Illumina HighSeq 2000) Re-sequencing of genes and/or genomic regions Library services Cloning and sequencing Identification of microorganisms Genotyping services Sanger DNA sequencing services

36 Limetec Biotechnologies GmbH Foundation: 2001 Employees: 20 Software development System integration Diagnostics for infectious diseases Analysis of genetic predisposition Market Segments Infectious diseases Pharmacogenomics Cardiology Biomarker identification and validation The company develops modern biomolecular methods and has brought already more than thirty innovative products on the market (CE marked products). High-speed and high-quality proof systems for the detection of bacteria and viruses Proof system for allelic discrimination detection for hereditary diseases High-sensitive and secure immunoblot for early detection of Lyme disease Software and device Creation of affordable communication solutions which connect ambulatory (out-patient) and stationary (in patient) care Limetec has developed an innovative webbased platform for laboratory orders. This innovative system provides versatile information, supports data exchange with the lab and makes cost transparency possible by allowing analyses of economic indicators. Close-partnered project TERA-Diagnostic MRSA detection Allelic discrimination assays (TaqMan method) Detection of human antibodies against Borrelia Drug resistance of Mycobacterium tuberculosis Limetec Biotechnologies GmbH Ladeburger Straße Bernau Germany Phone Fax

37 Medipan GmbH Developing, manufacturing and distributing in vitrodiagnostic assays in the field of organ-specific autoimmunity like thyroid diseases and type 1 diabetes Market leader in type 1 diabetes diagnostic; Inventor and market leader of the AKLIDES System, first system for fully automatic evaluation for cell-based immunofluorescence tests Currently distributing AKLIDES -assays for diagnostic of systemic rheumatic diseases (Hep2-cells, ANCA and Crithidia) Regarding AKLIDES as a multiparameter platform we are developing a bead system (ANA and ANCA diagnostic) and assays for other indications European distributor of rapid tests (diabetes, liver function, kidney function, urinary tract infection) for the use at home Operating worldwide Market Segments In vitro-diagnostics ELISA RIA (Digital) IFA (Hep2 cells, ANCA and Crithidia) Bead assays Platform technology of AKLIDES System Bead assays Medipan GmbH Ludwig-Erhard-Ring Dahlewitz/Berlin Germany Phone Fax info@medipan.de Dr. Christina Fritz (Head of Scientific Marketing)

38 -omics Technologies 1 Metanomics Health GmbH Metanomics Health a BASF Group company applies comprehensive Metabolite Profiling (metabolomics) with biomedical data interpretation. Metabolite Profiling is defined as the parallel analysis of multiple endogenous and xenobiotic metabolites in biological systems. The core expertise of Metanomics Health resides in discovery and validation of biomarkers. Market Segments Metanomics Health provides its services to pharmaceutical, diagnostics and nutrition companies. Technology applications include: Mechanism of action studies Mechanism of toxicity studies Translational and clinical biomarker development (e. g. PK/PD, patient stratification, efficacy and safety markers) Companion diagnostic development Cell culture and bioprocess optimization Metabolite profiling platform with more than 75 GC-MS and LC-MS/MS instruments Wide metabolite coverage via combination of unbiased and targeted platforms Unique tox mode of action prediction through MetaMap Tox database Excellence in systems correlation analysis of complex gene function relationships In cooperation with academic institutes and clinical experts Metanomics Health is running a large-scale diagnostic biomarker program. Areas include metabolic syndrome, heart failure, prostate cancer and multiple sclerosis to mention a few. Metanomics Health GmbH Tegeler Weg Berlin Germany

39 MicroDiscovery GmbH Foundation: 2000 Employees: 16 MicroDiscovery develops software and bioinformatics solutions for diagnostics, personalized medicine and molecular biology research. The portfolio also includes biostatistical data analysis and data management. Efficient proprietary algorithms are the basis for customer specific software for in vitro-diagnostics and medical technology. Software solutions can be developed as CE-certified, FDA compliant (21 CFR part ) and ISO compliant. MicroDiscovery is DIN ISO 9001:2008 certified by TÜV Rheinland. major R&D-Topics Market Segments Bioinformatics Software development for in vitro-diagnostics and biomedical instruments Data analyses for clinical and biological requirements Software development: Customer-specific OEM software development, algorithm development as well as biochips analysis software Data analysis: NGS/HTS data analysis service and data mining Biostatistical analysis: Evaluation of clinical studies, assay validation and biomarker validation Data management: Database development and data integration Development of multiparameter diagnostics Biomarker in complex diseases Systems biology for medical applications MicroDiscovery GmbH Marienburger Straße Berlin Germany Dr. Arif Malik