Diadexus Inc (DDXS) 0.7200 $DDXS
diaDexus' PLAC Test for Lp-PLA2 Activity accepted for US FDA's review
M2 - Fri Jul 18, 9:52AM CDT
Diagnostic company diaDexus (Other OTC
DXS) stated on Thursday that the traditional 510(k) submission of the PLAC Test for Lp-PLA2 Activity was found to contain all of the necessary information needed to proceed with the substantive review by the US Food and Drug Administration.
Companion Diagnostics in Personalized Medicine and Cancer Therapy
M2 - Mon Jul 07, 8:04AM CDT
Research and Markets (http://www.researchandmarkets.com/research/35n4zz/companion) has announced the addition of the "Companion Diagnostics in Personalized Medicine and Cancer Therapy" report to their offering. Companion diagnostics (CDx) refers to a particular clinical diagnostic test that is under evaluation and is specifically linked to a known drug therapy. This linkage could be important in the therapeutic application and clinical outcome of a drug, such as with personalized medicine for oncology patients. The molecular diagnostics field plays a vital part in personalized medicine and has greatly expanded over the past twenty years, expanding by more than 20% annually compared to most other laboratory procedures. Research will continue to produce an increased understanding of disease processes, and diagnostics manufacturers will continue to expand and refine the technology and automation needed for clinical testing. Companion diagnostics, although smaller at present, is one of the fastest growing segments in the in vitro diagnostic (IVD) market. And while the concept of a drug-diagnostic combination is not new, it has only recently started to generate interest with the move of healthcare towards pharmacogenomics. This TriMark Publications report examines the use of companion diagnostics in personalized medicine and cancer therapy. The study provides a qualitative and quantitative review of the industry, including cancer biomarker tests, pharmacogenomics tests, recurrence prediction tests, blood-based technologies, proteomics and regulatory trends. Moreover, this analysis profiles the leading companies that are developing and manufacturing companion diagnostics solutions. Each company is discussed in extensive depth with a section on its history, product line, business and marketing analysis, and a subjective commentary of the company's market position. Detailed tables and charts with sales forecasts and market share data are also included. Key Topics Covered: 1. Overview 1.1 Statement of Report 1.2 About This Report 1.3 Scope of the Report 1.4 Objectives 1.5 Methodology 1.6 Executive Summary 2. Companion Diagnostics and Personalized Medicine 2.1 Scope of This Section 2.2 Introduction to Companion Diagnostics and Personalized Medicine 2.3 Drug Metabolism, Companion Diagnostics and Personalized Medicine 2.4 Examples of Personalized Medicine and Companion Diagnostic Tests 2.5 Personalized Medicine and Companion Diagnostic Testing Product Pipeline 2.6 The Personalized Medicine Coalition (PMC) 2.7 Regulatory Trends and Guidelines in the Personalized Medicine Space 2.7.1 The Changing Regulatory Landscape for Personalized Medicine 2.8 Companion Diagnostics Play an Increasing Role in Cancer Care 2.9 Specific Examples of Clinical Situations where Companion Diagnostics are being Deployed 2.9.1 Epidermal Growth Factor Receptor Assay 2.9.2 Individualized Warfarin Therapy 2.9.3 UGT1A1 Molecular Assay for Camptosar 2.9.4 Response to Gleevec in Gastrointestinal Stromal Tumors (GISTs) 2.9.5 LabCorp, ARCA Personalized Medicine Deal for Cardiovascular Diseases 2.9.6 Osmetech Licenses Epidauros Biotechnologie AG CYP2D6 Biomarker to Enter Companion Diagnostics 2.9.7 Roche's Metastatic Melanoma Treatment, Zelboraf (vemurafenib) 2.9.8 Abbott's Late-Stage NSCLC Treatment, Xalkori (crizotinib) 2.10 Diagnostic Tests for Personalized Analysis of Cancer Therapy Effectiveness 2.11 Value Chain 2.12 Impact of Companion Diagnostics/Personalized Medicine on Drug Clinical Trials 3. Companion Diagnostics: Qualitative and Quantitative Market Analysis 3.1 Market Analysis of Molecular Diagnostics and Companion Diagnostics 3.2 Costs of Companion Diagnostics in Healthcare Expenditures 3.3 Molecular Diagnostic Market 3.4 Molecular Diagnostics Technology Platforms and Their Impact on Clinical Medicine 3.5 Snapshot of Companion Diagnostics Industry Structure 3.6 The Case for Theranostics 3.7 Companion Diagnostics Market Analysis Market Survey Data Characterizing the Qualitative and Quantitative Industry Parameters 4. Trends and Overview 4.1 Companion Diagnostics: Industry SWOT Analysis 4.2 Macro Trends in Companion Diagnostics 4.3 Challenges for Companion Diagnostics Development 4.4 Timeline for Impact of Various Segments in Companion Diagnostics 4.5 Use of Proteomics to Develop Individualized Tests 4.6 The Market Problem: Finding Value with Diagnostics for Personalized Medicine 5. Biomarker Tests Co-developed with Cancer Therapeutics as Companion Diagnostics 5.1 Sector Overview 5.1.1 Impact of New Technology Platforms 5.1.2 Impact on Drug Discovery 5.1.3 Biomarkers as Endpoints in Drug Discovery 5.1.4 Targeted Therapy 5.2 Companion Diagnostics on the Market 5.3 Epidermal Growth Factor Receptor Companions 5.3.1 Bevacizamab (Avastin) 5.3.2 EGFR for CRC and Camptosar (Irinotecan) 5.3.2.1 Companion Diagnostic Test Developed for UGT1A1 for Irinotecan 5.3.2.2 Companion Diagnostic Test Developed for Bristol-Myers' SPRYCEL 5.3.3 EGFR Express and Erbitux (Cetuximab) 5.3.4 HER2 and Heceptin (Trastuzumab) 5.3.4.1 Bayer's Advia Centaur HER2/neu Assay 5.3.4.2 Companies Marketing HER2/neu Assays 5.3.5 Iressa and Tarceva Companion Test 5.3.6 Tykerb (GlaxoSmithKline (GSK)) and Vectibix (Amgen) Companion Tests 5.3.7 EGFRx Assay 5.3.8 Monogram eTag 5.3.9 Veripath OncoDiagnostics EGFR PharmDX 5.3.10 NSCLC Patients with EGFR Mutation 5.3.11 A Personalized Medicine Program for CML 5.4 Companions Based on Myriad's IVDMIA Technology 5.4.1 Myriad's TheraGuide 5-FU 5.4.2 Myriad's BRCA Companion Diagnostics Testing for BioMarin's PARP Inhibitor BMN 673 5.5 Companions for Tyrosine Kinase Inhibitors: Erlotinib and Gefitinib 5.5.1 TheraScreen: EGFR29 5.5.2 The K-RAS Mutation Detection Kit 5.6 Irinotecan and UGT1A1 5.7 Gleevec (Imatinib) Companions 5.7.1 DakoCytomation's c-Kit (9.7) pharmDx 5.8 Companion Diagnostics Involving Metabolizing Enzymes 5.8.1 Companions for TMPT, CYP2C9 and UGT1A1 Enzymes 5.8.2 Companions for Aromatase Inhibitors 5.8.3 Companions for Actos and Avandia 5.9 Drivers and Barriers to Companion Diagnostics 5.10 Partnerships with Pharma Companies to Identify Therapeutic Targets 5.11 Circulating Tumor Cell Assay: Prognostic and Predictive Factors for Breast Cancer 5.12 Companion Diagnostics Used by Clinical Service Laboratories 5.13 New Technologies and Products under Development 5.13.1 OncoMethylome (now MDx Health) 5.13.2 Ventana Medical Systems Inks Companion Diagnostic Deal with Syndax for Lung Cancer Drug 5.13.3 Abbott Expands Agreement with GSK to Include Development of a Companion Diagnostic Test for the PRAME Antigen 5.14 Pharmacogenomics Tests 5.14.1 MGMT Methylation Assay 5.14.2 Other Pharmacogenomic Opportunities 5.15 Recurrence Prediction Tests 5.16 Blood-based Technologies 5.16.1 Oncotech 5.17 Monogram Biosciences HIV Personalized Platform 5.18 Wako LBA\AFP Test for Liver Cancer 5.19 Future Developments for Companion Diagnostics 5.20 Drug Response Predictors 6. Business and Regulatory Trends in the Companion Biomarker Testing Sector 6.1 Industry Consolidation 6.2 Breath of Product Offering and Pricing 6.3 Government Regulation of Medical Devices 6.3.1 FDA Guidance on Drug Test Co-development 6.3.2 Device Classes 6.3.3 Investigational Use of IVDMIAs 6.3.4 Post-market Requirements 6.3.5 Voluntary versus Required Submissions 6.3.6 Examples of Recent Voluntary Genomic Data Submissions 6.3.7 FDA Labeling Implications and Rules 6.3.8 Regulatory Activities in Companion Diagnostic Testing Translation of Diagnostic Testing Results into Clinical Practice 6.4 Strategic Business and Marketing Considerations 6.5 Commercial Opportunities in Companion Markers 6.6 Moderators of Growth 6.6.1 Roadblocks to Integrating Companion Biomarkers into Clinical Practice 6.6.2 Management of Targeted Therapeutics by Third-Party Payers 6.7 Biotechnology Industry Trends 6.8 Pharmaceutical Industry Trends 6.9 Acquisition, License Agreement, Partnerships 6.10 Legal Developments 6.11 Sales and Marketing Strategies for Tumor Marker Tests 6.11.1 International Markets 6.11.2 Europe 6.11.3 Central and South America 6.11.4 Asia-Pacific 6.12 Product Commercialization 6.13 Reimbursement 6.14 Self-Referral Rules 6.15 Health Insurance Portability and Accountability Act 6.16 Clinical Laboratory Improvement Amendments (CLIA) 6.17 In Vitro Diagnostic Directive (IVDD) and Medical Device Regulations 6.18 FDA's Quality System Regulation (QSR) 6.19 The FDA's OIVD on IVDMIAs 6.20 FDA's Qualification of Cancer Biomarkers 6.20.1 Regulatory Perspectives of Biomarker Validation 6.21 Genetic Tests and Medical Records 6.21.1 Laws against Genetic Discrimination 6.22 Global Drivers of Clinical Laboratory Testing 6.23 Global Outlook 6.24 Oncology Biomarker Qualification Initiative 6.25 FDA Critical Path 6.25.1 Examples of Drugs being Hindered due to Lack of Compliance with FDA Directives 6.26 Biomarkers and FDA's Voluntary Genomic Data Submission 6.27 From Personalized to Predictive Medicine 6.28 Analysis of Cost-Effectiveness at the Individual Level 6.29 The Patient and Advocate Perspective: An Evolution of Influence 6.30 Real-World Experiences Translating the Vision of Personalized Medicine into Practice 6.30.1 Evolving Business Models in Companion Diagnostics and Personalized Medicine 6.30.2 Current Pharma/Diagnostics Business Model Examples 6.31 Reimbursement and Value Creation 6.32 What is the Role of Governmental Agencies in Driving the Adoption of Companion Diagnostics? 6.33 What is the Role of the Insurance Industry in Driving the Adoption of pharmacogenomics (PGx)? 6.34 What is the Role of the Pharma Industry in Driving the Adoption of PGx? 6.35 FDA Guidance Document on Co-development 6.36 What is the Role of the Diagnostic Industry in Driving the Adoption of PGx? 6.37 What is the Future Role of PBMs in Laboratory Services? 7. Companies Entering the Companion Diagnostics Market 7.1 Industry Overview 7.1.1 20/20 GeneSystems, Inc. 7.1.2 Abbott Molecular, Inc. 7.1.3 Affymetrix, Inc. 7.1.4 Agendia BV 7.1.5 Agensys, Inc. 7.1.6 Agilent Technologies 7.1.7 Almac Group 7.1.8 AMDL, Inc. 7.1.9 Applied Biosystems 7.1.10 Asuragen, Inc. 7.1.11 Aureon Laboratories Corporation 7.1.12 Beckman Coulter, Inc. 7.1.13 Becton, Dickinson and Company (BD) Diagnostics - TriPath 7.1.14 Biocode Hycel 7.1.15 BioCurex, Inc. 7.1.16 Biodesix 7.1.17 Biomarker Technologies, LLC 7.1.18 Biomedical Diagnostics, LLC 7.1.19 Biomerica 7.1.20 bioM?rieux, Inc. 7.1.21 Biomira, Inc. 7.1.22 BioModa, Inc. 7.1.23 Bruker Daltonics 7.1.24 Byk Gulden 7.1.25 Cangen Biotechnologies, Inc. 7.1.26 Caprion Proteomics 7.1.27 Celera Diagnostics 7.1.28 Cepheid, Inc. 7.1.29 Clarient, Inc. 7.1.30 Claros Diagnostics 7.1.31 Clinical Data, Inc.: PGxHealth and Cogenics 7.1.32 Correlogic Systems, Inc. 7.1.33 CytoCore, Inc. (Formerly Known As Molecular Diagnostics, Inc.) 7.1.34 Cytogen Corporation (now EUSA Pharma) 7.1.35 Dako (Formerly DakoCytomation) 7.1.36 DiaDexus 7.1.37 DiagnoCure 7.1.38 DRG International 7.1.39 EDP Biotech Corporation 7.1.40 Eisai Co., Ltd. 7.1.41 Epigenomics 7.1.42 EXACT Sciences Corporation 7.1.43 Exagen Diagnostics 7.1.44 Gene Logic, Inc. 7.1.45 Genesis Genomics, Inc. (now known as Mitomics) 7.1.46 GenMark Diagnostics 7.1.47 Genomic Health 7.1.48 Gen-Probe, Inc. 7.1.49 Health Discovery Corporation 7.1.50 Hologic, Inc. (Formerly Cytyc Corporation) 7.1.51 Ikonisys, Inc. 7.1.52 Illumina 7.1.53 Immunomedics 7.1.54 Incyte 7.1.55 InterGenetics 7.1.56 Ipsogen 7.1.57 Johnson & Johnson 7.1.58 LabCorp 7.1.59 Life Technologies Corporation 7.1.60 Matritech, Inc. 7.1.61 Miraculins 7.1.62 Mitsubishi Kagaku latron 7.1.63 Monogram Biosciences (formerly ViroLogic Inc.) 7.1.64 Myriad Genetics, Inc. 7.1.65 NimbleGen Systems 7.1.66 Northwest Biotherapeutics, Inc. 7.1.67 Novartis MDx 7.1.68 Nycomed 7.1.69 Oncotech, Inc. 7.1.70 Oncothyreon, Inc. (Formerly known as Biomira) 7.1.71 Orion Genomics 7.1.72 Oxford BioTherapeutics (formerly Oxford Genome Sciences) 7.1.73 Panacea Pharmaceuticals, Inc. 7.1.74 Polymedco, Inc. 7.1.75 Power3 Medical Products 7.1.76 Prometheus 7.1.77 Proteome Systems Limited 7.1.78 Qiagen N.V. 7.1.79 Roche Molecular Diagnostics 7.1.80 Sanko Junyaku Co. Ltd. 7.1.81 SensiGen, LLC 7.1.82 Siemens Healthcare Diagnostics, Inc. 7.1.83 SuperArray Bioscience Corporation 7.1.84 Third Wave Technologies, Inc. (now owned by Hologic) 7.1.85 Tosoh Biosciences 7.1.86 TrimGen 7.1.87 Upstream Biosciences, Inc. 7.1.88 Ventana Medical Systems, Inc. 7.1.89 Veridex, LLC 7.1.90 Vermillion, Inc. (Formerly Ciphergen) 7.1.91 Vertex Pharmaceuticals, Inc. Appendix 1: FDA Guidance for Industry: Pharmacogenomic Data Submissions A1.1 Introduction A1.2 Background A1.3 Submission Policy A1.3.1 General Principles A1.3.2 Specific Uses of Pharmacogenomic Data in Drug Development and Labeling A1.3.3 Benefits of Voluntary Submissions to Sponsors and FDA A1.4 Submission of Pharmacogenomic Data A1.4.1 Submission of Pharmacogenomic Data During the IND Phase A1.4.2 Submission of Pharmacogenomic Data to a New NDA, BLA or Supplement A1.4.3 Submission to a Previously Approved NDA or BLA A1.4.4 Compliance with 21 CFR Part 58 A1.4.5 Submission of Voluntary Genomic Data from Application-Independent Research A1.5 Format and Content of a VGDS A1.6 Process for Submitting Pharmacogenomic Data A1.7 Agency Review of VGDSs Appendix 2: FDA Issues Draft Companion Diagnostic Guidance Appendix 3: Histochemical Markers for Cancer Glossary INDEX OF FIGURES Figure 2.1: Personalizing Drug Treatment 18 Figure 2.2: Approaches to Personalized Medicine 19 Figure 2.3: The Phase I and II Processes of Drug Metabolism 22 Figure 2.4: Hepatic Distribution of Human CYP450 23 Figure 2.5: Relative Contribution of CYP450 Enzymes to Drug Metabolism 24 Figure 2.6: Genetic Components Determine Drug Metabolism 24 Figure 2.7: Personalized Medicine Drugs in Development 29 Figure 2.8: Healthcare Value Chain 49 Figure 3.1: From Genetic Content to Personalized Medicine 52 Figure 3.2: Impact of Diagnostic Testing on Healthcare Decision-Making 52 Figure 3.3: Impact of Diagnostic Testing on Healthcare Spending 53 Figure 3.4: Breakout of the Molecular Diagnostics Marketplace 54 Figure 3.5: Molecular Diagnostics Market Segmentation 55 Figure 3.6: Molecular Diagnostics Market Segmentation by Technology 55 Figure 3.7: Market Survey Respondent Demographics 60 Figure 3.8: Breakout of the Respondent Pool by Affiliation 60 Figure 3.9: Segmentation of the Personalized Medicine Market 61 Figure 4.1: Personalized Medicine Market Drivers 63 Figure 4.2: Challenges in the Personalized Medicine Space 64 Figure 5.1: Carcinogenesis is a Multi-Step Process 72 Figure 5.2: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results with IHC 79 Figure 5.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH 79 Figure 7.1: Epigenomics Product Development Pipeline 163 INDEX OF TABLES Table 2.1: Timeline for Development of Companion Diagnostics 19 Table 2.2: Personalized Medicine at the Nexus Point 20 Table 2.3: Percentage of Non-Responders in Various Drug Classes 21 Table 2.4: High-Profile Drug Withdrawals from the Marketplace 21 Table 2.5: Metabolism of Drugs by Hepatic Enzymes 23 Table 2.6: Drug Metabolism Drives Drug Efficacy/Toxicity 25 Table 2.7: Population Frequency of the Various Cytochromes 26 Table 2.8: Selected List of Personalized Medicine Tests 28 Table 2.9: Personalized Medicine and Companion Diagnostics Product Pipeline 30 Table 2.10: Typical Response Rates in Therapeutic Areas 42 Table 2.11: Prevalence of People Taking Medications Metabolized by Liver Enzymes 43 Table 2.12: UGT1A1 Helps to Determine Risks Associated with Irinotecan 45 Table 2.13: Current Product Labels: Enzyme Metabolism 45 Table 3.1: Timeline for Impact of Various Molecular Diagnostics Technologies on Personalized Medicine 56 Table 3.2: Impact of Molecular Diagnostics Technologies on Therapeutic Areas in Personalized Medicine 56 Table 3.3: Challenges of Various Molecular Diagnostics Technology Platforms in Personalized Medicine 57 Table 3.4: FDA Classification of Diagnostics by Risk 59 Table 4.1: Personalized Medicine Industry SWOT Analysis 62 Table 4.2: Market Opportunities in Personalized Medicine 65 Table 4.3: Challenges for Market Adoption of Various Personalized Medicine Tests 66 Table 4.4: Hurdles to Personalized Medicine and Companion Diagnostics Development 67 Table 4.5: Timeline of Impact in Areas of Personalized Medicine 68 Table 4.6: Impact of Personalized Medicine on Various Therapeutic Areas 69 Table 5.1: Potential Benefits of Biomarkers as Companion Diagnostics 74 Table 5.2: Utility of Biomarker as Companion Diagnostics to Drug Development 74 Table 5.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: How to Interpret Test Results 78 Table 5.4: Device Submission Elements for the FDA 87 Table 6.1: List and Discounted Prices for Abbott Tumor Marker Tests 95 Table 6.2: Summary of Biomarker Use in the Commercialization of Novel Oncology Pharmacotherapeutics 123 Table 6.3: Pharmacoeconomic Challenges to the Implementation of Biomarkers as Companion Diagnostic Tests 123 Table 7.1: Major Players in Companion Diagnostics Sector 127 Table 7.2: Opportunities for Biomarkers in Cancer Diagnosis and Treatment 152 Table 7.3: Tumor Diagnosis Immunoassay 161 Table 7.4: Tumor Diagnosis Radioimmunoassay 162 Table 7.5: Summary of Matritech's Product Development Programs 179 Companies Mentioned - 20/20 GeneSystems - Abbott Diagnostics - Affymetrix - Agendia BV - Agensys - Almac Group - AMDL - Arcturus Bioscience - Aureon Biosciences - Beckman Coulter - Biocode S.A. - BioCurex - Biomarker Technologies - Biomedical Diagnostics - Biomerica - bioM?rieux - Biomira - BioModa - Bruker Daltonics - Byk Gulden - Cangen Biotechnologies - Caprion Proteomics - Celera Diagnostics - Cepheid - Claros Diagnostics - Clinical Data: PGxHealth and Cogenics - Ciphergen Biosystems - Clarient - Correlogic Systems - Cytogen - Cytyc Corporation - Dako - DiaDexus LLC - Digene Corporation - DiagnoCure - Diagnostic Systems Laboratories - DRG International - DxS - EDP Biotech - Epigenomics - Exact Sciences Corporation - Exagen Diagnostics - Gene Logic - Genesis Genomics - Genomic Health - Gen-Probe - Health Discovery Corporation - Ikonisys - Immunicon - Immunomedics - Incyte Pharmaceuticals - InterGenetics - Ipsogen - LabCorp - Matritech - Miraculins - Mitsubishi Kagaku Medical - Molecular Diagnostics (CytoCore) - Monogram Biosciences - Myriad Genetics - NimbleGen Systems - Northwest Biotherapeutics - Oncotech - Orion Genomics - Oxford Genome Sciences - Panacea Pharmaceuticals - Perlegen Sciences - Polymedco - Power3 Medical Products - Prometheus - Proteome Systems - Qiagen - Sanko Junyaku - SensiGen - SuperArray Bioscience - Third Wave Technologies - Tosoh Medics - TrimGen - TriPath Imaging - Upstream Biosciences - Ventana Medical Systems - Veridex For more information visit http://www.researchandmarkets.com/research/35n4zz/companion About Research and Markets Research and Markets is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
diaDexus Announces Leadership Changes to Drive and Support Future Growth Potential
Business Wire - Wed Jun 25, 7:30AM CDT
-- Alexander Johnson, formerly of Novartis AG, to Join as President -
2014 Automated Microbiology Market -- A Global Strategic Outlook: Molecular Diagnostics, Microbial Identification, Blood Culture, Urine Screening and Immunodiagnostics
M2 - Tue Feb 18, 8:31AM CST
Research and Markets (http://www.researchandmarkets.com/research/48jvmv/2014_automated) has announced the addition of the "2014 Automated Microbiology Market -- A Global Strategic Outlook: Molecular Diagnostics, Microbial Identification, Antibiotic Susceptibility, Blood Culture, Urine Screening, Immunodiagnostics" report to their offering. '2014 Automated Microbiology Market--A Global Strategic Outlook' is a new seven-country strategic analysis of the major business opportunities emerging in the automated microbiology market during the next five years. The report examines key trends in the U.S., five major European countries (France, Germany, Italy, Spain, UK) and Japan; reviews current and emerging assays; analyzes potential applications of innovative diagnostic technologies; forecasts volume and sales for molecular diagnostic, microbial identification, antibiotic susceptibility, blood culture, urine screening and immunodiagnostic procedures, as well as over 100 infectious disease tests by assay, application, market segment, and country; profiles leading players and potential market entrants; and suggests alternative business expansion strategies for suppliers. This comprehensive seven-country report will assist diagnostics industry executives, as well as companies planning to diversify into the dynamic and rapidly expanding microbiology market, in evaluating emerging opportunities and developing effective business strategies. Worldwide Market Overview - Estimated universe of laboratories performing microbiology testing by country. - Specimen, test volume and sales forecasts by country. Market Segmentation Analysis - Sales and market shares for major suppliers by individual test and country. - Volume and sales forecasts for over 100 infectious disease assays by individual test and country. - Test volume estimates by method (molecular, serology/immunodiagnostics, culture/microscopy). - Review of the market dynamics, trends, structure, size, growth and major suppliers by country Companies Mentioned: - Abbott - Affymetrix - Agilent Technologies - Arca/Nuvelo - Beckman Coulter/Danaher - Becton Dickinson - Biokit - bioMerieux - Bio-Rad - Biotest - Caliper - Cepheid - Decode - Diadexus - Diamedix - DiaSorin - Eiken Chemical - Enzo Biochem - Exact Sciences - Fujirebio/Innogenetics - Hologic/Gen-Probe - Illumina - ID Biomedical/GSK - Kreatech - Li-Cor Biosciences - Life Technology - Lonza - Monogram Biosciences - Myriad Genetics - Nanogen/Elitech - Novartis Diagnostics/Grifols - Orchid CellMark - Ortho-Clinical Diagnostics - Proteome Sciences - Qiagen - Roche - Scienion - Sequenom - SeraCare - Siemens - Sierra Molecular - Shimadzu - Takara Bio - Tecan - Thermo Fisher - Wallac/PE - Wako For more information visit http://www.researchandmarkets.com/research/48..._automated About Research and Markets Research and Markets is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
2014 Analysis of the US Hospital Cancer Diagnostics Market
M2 - Thu Feb 13, 3:25AM CST
Research and Markets (http://www.researchandmarkets.com/research/g5hk8t/2014_analysis_of) has announced the addition of the "2014 Analysis of the US Hospital Cancer Diagnostics Market" report to their offering. This new report contains 533 pages, 43 tables, and presents a comprehensive analysis of the US hospital cancer diagnostics market, including: - Major issues pertaining to the French hospital laboratory practice, as well as key economic, regulatory, demographic, social and technological trends with significant market impact during the next five years. - Mortality statistics and scientific views on the etiology of major types of cancer, e.g., lung, colorectal, breast, prostatic, pancreatic, leukemia, lymphoma, gastrointestinal, bladder, liver, ovarian, testicular, oral, skin and others. - Test volume and sales forecasts for 40 cancer diagnostic procedures performed in French hospitals. - Current instrumentation technologies and feature comparison of leading analyzers. - Sales and market shares of leading suppliers. - Emerging diagnostic technologies and their potential market applications. - Product development opportunities. - Profiles of current and emerging suppliers, including their sales, market shares, product portfolios, marketing tactics, technological know-how, new products in R&D, collaborative arrangements and business strategies. - Business opportunities and strategic recommendations for suppliers. Key Topics Covered: Introduction Worldwide Market and Technology Overview A. Cancer Statistics and Etiology B. Major Current And Emerging Cancer Diagnostic Tests C. Instrumentation Review And Market Needs D. Current and Emerging Technologies US A. Executive Summary B. Business Environment C. Market Structure D. Market Size, Growth and Major Suppliers Major Product Development Opportunities A. Reagent Kits and Test Systems/Panels B. Instrumentation C. Computers, Software and Automation D. Auxiliary Products Design Criteria for Decentralized Testing Products Alternative Market Penetration Strategies A. Internal Development B. Collaborative Arrangements C. University Contracts D. Distribution Strategies 1. Marketing Approaches 2. Product Complexity 3. Customer Preference 4. Established Suppliers 5. Emerging Suppliers 6. Major Types of Distributors 7. Market Segmentation Factor Potential Market Entry Barriers and Risks A. Market Maturity B. Cost Containment C. Competition D. Technological Edge and Limitations E. Patent Protection F. Regulatory Constraints G. Decentralized Testing Market Challenges Companies Mentioned: - Abbott - AdnaGen - Applied Gene Technologies - Arca - Beckman Coulter/Danaher - Becton Dickinson - Biomedical Diagnostics - bioMerieux - Bio-Rad - Cepheid - Correlogic Systems - Dako - Decode - Diadexus - Diagnocure - Diasorin - Eiken Chemical - Enterix - Enzo Biochem - Epigenomics - Exact Sciences - Fujirebio - Gen-Probe - Guided Therapeutics - Hologic - Ipsogen - Kreatech - Kyowa Medex - Life Technologies - Mackay Life Sciences - Myriad Genetics - Nanogen Elitech - OncoLab - Otho-Clinical Diagnostics - Panacea Pharmaceuticals - Polartechnics - Polymedco - PreMD - Qiagen - Radient Pharmaceuticals - Roche - Scienion - Sequenom - Siemens Healthcare - Takara Bio - Targeted Diagnostics & Therapeutics - Tosoh - Veridex - Wako Pure Chemicals - Wallac/PE - Zila For more information visit http://www.researchandmarkets.com/research/g5...nalysis_of
2014 Analysis of the World Cancer Diagnostic Testing Market: Country Segment Forecasts, Market Shares, Emerging Technologies, Competitive Strategies, Growth Opportunities
M2 - Mon Feb 10, 2:54AM CST
Research and Markets (http://www.researchandmarkets.com/research/r66j8d/2014_analysis_of) has announced the addition of the "2014 Analysis of the World Cancer Diagnostic Testing Market: Country Segment Forecasts, Market Shares, Emerging Technologies, Competitive Strategies, Growth Opportunities" report to their offering. This new report contains 1,200 pages, 450 tables and provides forecasts for 40 tumor markers by country and market segment, as well as sales and market shares for reagent and instrument suppliers. The report is available by region, country, section, market segment and individual test: Regions: Global, Europe Countries: France, Germany, Italy, Japan, Spain, UK, USA Sections: Assays, Competitors, Instrumentation, Technologies Market Segments: Hospitals (France, Germany, Italy, Japan, Spain, UK, USA), Personalized Testing Tests: AFP, Beta-2 Microglobulin,CA Tumor Markers, CEA, Cell Surface Markers, Occult Blood, PAP, Pap Smear/HPV, PSA To purchase a DataPack that includes (test volumes, sales forecasts, supplier shares) please E-mail us. Key Topics Covered: Introduction Worldwide Market and Technology Overview A. Cancer Statistics and Etiology B. Major Current And Emerging Cancer Diagnostic Tests C. Instrumentation Review And D. Current and Emerging Technologies Competitive Profiles - Abbott - AdnaGen - Applied Gene Technologies - Arca - Beckman Coulter/Danaher - Becton Dickinson - Bio-Rad - Biomedical Diagnostics - Cepheid - Correlogic Systems - Dako - Decode - Diadexus - Diagnocure - Diasorin - Eiken Chemical - Enterix - Enzo Biochem - Epigenomics - Exact Sciences - Fujirebio - Gen-Probe - Guided Therapeutics - Hologic - Ipsogen - Kreatech - Kyowa Medex - Life Technologies - Mackay Life Sciences - Myriad Genetics - Nanogen Elitech - OncoLab - Otho-Clinical Diagnostics - Panacea Pharmaceuticals - Polartechnics - Polymedco - PreMD - Qiagen - Radient Pharmaceuticals - Roche - Scienion - Sequenom - Siemens Healthcare - Takara Bio - Targeted Diagnostics & Therapeutics - Tosoh - Veridex - Wako Pure Chemicals - Wallac/PE - Zila - bioMerieux For more information visit http://www.researchandmarkets.com/research/r6...nalysis_of About Research and Markets Research and Markets is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
Baytex to Present at CIBC Whistler Institutional Investor Conference
Marketwire Canada - Wed Jan 15, 3:14PM CST
Baytex Energy Corp. (TSX:BTE)(NYSE:BTE) is pleased to announce that James Bowzer, President and Chief Executive Officer, will be presenting at the CIBC Whistler Institutional Investor Conference on Wednesday, January 22, 2014 at 4:00 pm PST (5:00 pm MST) in Whistler, British Columbia. Interested parties can listen to a live webcast and view the presentation slides via the following URL:
Niko Receives Conversion Notice
Marketwire - Thu Jan 09, 5:01PM CST
Niko Resources Ltd. (TSX: NKO) announces that on January 8, 2014, it received a notice of conversion in accordance with the terms of the amended and restated 7% senior unsecured notes due July 13, 2014 (the "Notes"
to convert approximately US$0.25 million of the Notes. The conversion will result in the issuance of 120,904 common shares to a holder of the Notes and the outstanding principal balance of the Notes will be approximately US$8.3 million.
Baxano Surgical (BAXS) Jumps: Stock Adds 7.8% - Tale of the Tape
Zacks Equity Research - Zacks Investment Research - Mon Jan 06, 7:51AM CST
Baxano Surgical, Inc. was a big mover last session, as its shares rose almost 8% on the day.
Neogen Acquires Insecticide Maker - Analyst Blog
Zacks Equity Research - Zacks Investment Research - Fri Jan 03, 2:10PM CST
NEOG has a long-term association with Chem-Tech as it has used the latter's Prozap trademark for a number of years for some rodenticides.
EnteroMedics (ETRM) Jumps: Stock Adds 7.8% in Session - Tale of the Tape
Zacks Equity Research - Zacks Investment Research - Fri Jan 03, 8:39AM CST
EnteroMedics Inc. was a big mover last session, as its shares rose almost 8% on the day.
Wright Medical Hits New 52-Week High - Analyst Blog
Zacks Equity Research - Zacks Investment Research - Thu Jan 02, 9:39AM CST
Shares of WMGI closed at $30.71 on the same day, representing a strong one-year return of 46.3%.
Omeros Corp. (OMER) Jumps: Stock Rises 18.1% - Tale of the Tape
Zacks Equity Research - Zacks Investment Research - Thu Dec 19, 7:11AM CST
Omeros (OMER) was a big mover last session, as the company saw its shares rise by over 18% on the day.
2014 Analysis of the UK Hospital Cancer Diagnostics Market Gives Sales Forecasts for 40 Cancer Diagnostic Procedures
M2 - Mon Dec 16, 5:18AM CST
Research and Markets (http://www.researchandmarkets.com/research/5tjpfw/2014_analysis_of) has announced the addition of the "2014 Analysis of the UK Hospital Cancer Diagnostics Market" report to their offering. This new report contains 533 pages, 43 tables, and presents a comprehensive analysis of the UK hospital cancer diagnostics market, including: - Major issues pertaining to the French hospital laboratory practice, as well as key economic, regulatory, demographic, social and technological trends with significant market impact during the next five years. - Mortality statistics and scientific views on the etiology of major types of cancer, e.g., lung, colorectal, breast, prostatic, pancreatic, leukemia, lymphoma, gastrointestinal, bladder, liver, ovarian, testicular, oral, skin and others. - Test volume and sales forecasts for 40 cancer diagnostic procedures performed in French hospitals. - Current instrumentation technologies and feature comparison of leading analyzers. - Sales and market shares of leading suppliers. - Emerging diagnostic technologies and their potential market applications. - Product development opportunities. - Profiles of current and emerging suppliers, including their sales, market shares, product portfolios, marketing tactics, technological know-how, new products in R&D, collaborative arrangements and business strategies. - Business opportunities and strategic recommendations for suppliers. Companies Mentioned: - Abbott - Applied Gene Technologies - Beckman Coulter/Danaher - Becton Dickinson - Biomedical Diagnostics - bioMerieux - Bio-Rad - Cepheid - Correlogic Systems - Dako - Decode - Diadexus - Eiken Chemical - Fujirebio - Gen-Probe - Hologic - Ipsogen - Kreatech - Kyowa Medex - Life Technologies - Mackay Life Sciences - Myriad Genetics - Otho-Clinical Diagnostics - Polymedco - Qiagen - Radient Pharmaceuticals - Roche - Siemens Healthcare - Takara Bio - Targeted Diagnostics & Therapeutics - Tosoh - Veridex - Wako Pure Chemicals - Wallac/PE - Zila For more information visit http://www.researchandmarkets.com/research/5t...nalysis_of About Research and Markets Research and Markets is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
2014 Analysis of CEA Testing Technologies and Emerging Markets Profiles Leading Suppliers and Recent Market Entrants
M2 - Mon Dec 16, 5:13AM CST
Research and Markets (http://www.researchandmarkets.com/research/skd2lp/2014_analysis_of) has announced the addition of the "2014 Analysis of CEA Testing Technologies and Emerging Markets" report to their offering. This report contains 250 pages, 15 tables and presents a detailed analysis of the CEA testing market in the US, Europe (France, Germany, Italy, Spain, UK) and Japan, including clinical significance and current laboratory practice; 5- and 10-year test volume and sales forecasts by country and market segment; as well as sales and market shares for major suppliers. The cancer diagnostics market is on the verge of explosion, as the researchers approach major technological breakthroughs in tumor diagnosis and therapy, discover new specific antigens, and unlock the mystery of the genetic basis of the disease. During the next ten years, the worldwide cancer testing market is promising to be an exciting, dynamic and rapidly expanding field. Anticipated technological breakthroughs will create numerous opportunities for determining genetic predisposition, detecting specific tumors, and monitoring biological response to cancer therapy. The rise in geriatric population will further compound the growing demand for malignancy assays and the rapid market expansion worldwide. The report also examines market applications of DNA probes, biochips/microarrays, monoclonal antibodies, immunoassays, IT, chromosome analysis, and other technologies; reviews features and operating characteristics of automated analyzers; profiles leading suppliers and recent market entrants developing innovative technologies and products; and identifies alternative market penetration strategies and entry barriers/risks. Companies Mentioned: - Abbott - AdnaGen - Applied Gene Technologies - Arca - Beckman Coulter/Danaher - Becton Dickinson - Biomedical Diagnostics - bioMerieux - Bio-Rad - Cepheid - Correlogic Systems - Dako - Decode - Diadexus - Diagnocure - Diasorin - Eiken Chemical - Enterix - Enzo Biochem - Epigenomics - Exact Sciences - Fujirebio - Gen-Probe - Guided Therapeutics - Hologic - Ipsogen - Kreatech - Kyowa Medex - Life Technologies - Mackay Life Sciences - Myriad Genetics - Nanogen Elitech - OncoLab - Ortho-Clinical Diagnostics - Panacea Pharmaceuticals - Polartechnics - Polymedco - PreMD - Qiagen - Radient Pharmaceuticals - Roche - Scienion - Sequenom - Siemens Healthcare - Takara Bio - Targeted Diagnostics & Therapeutics - Tosoh - Veridex - Wako Pure Chemicals - Wallac/PE - Zila For more information visit http://www.researchandmarkets.com/research/sk...nalysis_of About Research and Markets Research and Markets is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
Covidien to Buy GivenImaging, Shares Rise - Analyst Blog
Zacks Equity Research - Zacks Investment Research - Tue Dec 10, 10:10AM CST
The addition of Given Imaging's products to Covidien's portfolio serves its strategy to support physicians with products that range from diagnosis to treatment.
Alere Develops Health Information in U.K. - Analyst Blog
Zacks Equity Research - Zacks Investment Research - Thu Sep 12, 4:50PM CDT
Alere will establish a site in Leeds to support this project.
PerkinElmer Launches SCID Test - Analyst Blog
Zacks Equity Research - Zacks Investment Research - Tue Sep 03, 12:50PM CDT
PerkinElmer is dedicated in offering products and systems for prenatal clinical problems
diaDexus, Inc. Appoints Ralf Schoenbrunner to Senior Vice President, Research and Early Development
Business Wire - Thu Aug 22, 7:00AM CDT
diaDexus, Inc. (OTCQB DXS), a company developing and commercializing proprietary cardiovascular diagnostic products, today announced that E. Ralf Schoenbrunner, Ph.D. has been appointed to the position of senior vice president of research and early development. Dr. Schoenbrunner has more than 20 years of experience in the medical device and diagnostic field including executing multiple successful product development projects.
diaDexus, Inc. Reports Second Quarter 2013 Financial Results
GlobeNewswire - Thu Aug 08, 3:05PM CDT
12th Consecutive Quarter of Year-over-Year Revenue Growth
diaDexus' PLAC Test for Lp-PLA2 Activity accepted for US FDA's review
M2 - Fri Jul 18, 9:52AM CDT
Diagnostic company diaDexus (Other OTC
DXS) stated on Thursday that the traditional 510(k) submission of the PLAC Test for Lp-PLA2 Activity was found to contain all of the necessary information needed to proceed with the substantive review by the US Food and Drug Administration. Companion Diagnostics in Personalized Medicine and Cancer Therapy
M2 - Mon Jul 07, 8:04AM CDT
Research and Markets (http://www.researchandmarkets.com/research/35n4zz/companion) has announced the addition of the "Companion Diagnostics in Personalized Medicine and Cancer Therapy" report to their offering. Companion diagnostics (CDx) refers to a particular clinical diagnostic test that is under evaluation and is specifically linked to a known drug therapy. This linkage could be important in the therapeutic application and clinical outcome of a drug, such as with personalized medicine for oncology patients. The molecular diagnostics field plays a vital part in personalized medicine and has greatly expanded over the past twenty years, expanding by more than 20% annually compared to most other laboratory procedures. Research will continue to produce an increased understanding of disease processes, and diagnostics manufacturers will continue to expand and refine the technology and automation needed for clinical testing. Companion diagnostics, although smaller at present, is one of the fastest growing segments in the in vitro diagnostic (IVD) market. And while the concept of a drug-diagnostic combination is not new, it has only recently started to generate interest with the move of healthcare towards pharmacogenomics. This TriMark Publications report examines the use of companion diagnostics in personalized medicine and cancer therapy. The study provides a qualitative and quantitative review of the industry, including cancer biomarker tests, pharmacogenomics tests, recurrence prediction tests, blood-based technologies, proteomics and regulatory trends. Moreover, this analysis profiles the leading companies that are developing and manufacturing companion diagnostics solutions. Each company is discussed in extensive depth with a section on its history, product line, business and marketing analysis, and a subjective commentary of the company's market position. Detailed tables and charts with sales forecasts and market share data are also included. Key Topics Covered: 1. Overview 1.1 Statement of Report 1.2 About This Report 1.3 Scope of the Report 1.4 Objectives 1.5 Methodology 1.6 Executive Summary 2. Companion Diagnostics and Personalized Medicine 2.1 Scope of This Section 2.2 Introduction to Companion Diagnostics and Personalized Medicine 2.3 Drug Metabolism, Companion Diagnostics and Personalized Medicine 2.4 Examples of Personalized Medicine and Companion Diagnostic Tests 2.5 Personalized Medicine and Companion Diagnostic Testing Product Pipeline 2.6 The Personalized Medicine Coalition (PMC) 2.7 Regulatory Trends and Guidelines in the Personalized Medicine Space 2.7.1 The Changing Regulatory Landscape for Personalized Medicine 2.8 Companion Diagnostics Play an Increasing Role in Cancer Care 2.9 Specific Examples of Clinical Situations where Companion Diagnostics are being Deployed 2.9.1 Epidermal Growth Factor Receptor Assay 2.9.2 Individualized Warfarin Therapy 2.9.3 UGT1A1 Molecular Assay for Camptosar 2.9.4 Response to Gleevec in Gastrointestinal Stromal Tumors (GISTs) 2.9.5 LabCorp, ARCA Personalized Medicine Deal for Cardiovascular Diseases 2.9.6 Osmetech Licenses Epidauros Biotechnologie AG CYP2D6 Biomarker to Enter Companion Diagnostics 2.9.7 Roche's Metastatic Melanoma Treatment, Zelboraf (vemurafenib) 2.9.8 Abbott's Late-Stage NSCLC Treatment, Xalkori (crizotinib) 2.10 Diagnostic Tests for Personalized Analysis of Cancer Therapy Effectiveness 2.11 Value Chain 2.12 Impact of Companion Diagnostics/Personalized Medicine on Drug Clinical Trials 3. Companion Diagnostics: Qualitative and Quantitative Market Analysis 3.1 Market Analysis of Molecular Diagnostics and Companion Diagnostics 3.2 Costs of Companion Diagnostics in Healthcare Expenditures 3.3 Molecular Diagnostic Market 3.4 Molecular Diagnostics Technology Platforms and Their Impact on Clinical Medicine 3.5 Snapshot of Companion Diagnostics Industry Structure 3.6 The Case for Theranostics 3.7 Companion Diagnostics Market Analysis Market Survey Data Characterizing the Qualitative and Quantitative Industry Parameters 4. Trends and Overview 4.1 Companion Diagnostics: Industry SWOT Analysis 4.2 Macro Trends in Companion Diagnostics 4.3 Challenges for Companion Diagnostics Development 4.4 Timeline for Impact of Various Segments in Companion Diagnostics 4.5 Use of Proteomics to Develop Individualized Tests 4.6 The Market Problem: Finding Value with Diagnostics for Personalized Medicine 5. Biomarker Tests Co-developed with Cancer Therapeutics as Companion Diagnostics 5.1 Sector Overview 5.1.1 Impact of New Technology Platforms 5.1.2 Impact on Drug Discovery 5.1.3 Biomarkers as Endpoints in Drug Discovery 5.1.4 Targeted Therapy 5.2 Companion Diagnostics on the Market 5.3 Epidermal Growth Factor Receptor Companions 5.3.1 Bevacizamab (Avastin) 5.3.2 EGFR for CRC and Camptosar (Irinotecan) 5.3.2.1 Companion Diagnostic Test Developed for UGT1A1 for Irinotecan 5.3.2.2 Companion Diagnostic Test Developed for Bristol-Myers' SPRYCEL 5.3.3 EGFR Express and Erbitux (Cetuximab) 5.3.4 HER2 and Heceptin (Trastuzumab) 5.3.4.1 Bayer's Advia Centaur HER2/neu Assay 5.3.4.2 Companies Marketing HER2/neu Assays 5.3.5 Iressa and Tarceva Companion Test 5.3.6 Tykerb (GlaxoSmithKline (GSK)) and Vectibix (Amgen) Companion Tests 5.3.7 EGFRx Assay 5.3.8 Monogram eTag 5.3.9 Veripath OncoDiagnostics EGFR PharmDX 5.3.10 NSCLC Patients with EGFR Mutation 5.3.11 A Personalized Medicine Program for CML 5.4 Companions Based on Myriad's IVDMIA Technology 5.4.1 Myriad's TheraGuide 5-FU 5.4.2 Myriad's BRCA Companion Diagnostics Testing for BioMarin's PARP Inhibitor BMN 673 5.5 Companions for Tyrosine Kinase Inhibitors: Erlotinib and Gefitinib 5.5.1 TheraScreen: EGFR29 5.5.2 The K-RAS Mutation Detection Kit 5.6 Irinotecan and UGT1A1 5.7 Gleevec (Imatinib) Companions 5.7.1 DakoCytomation's c-Kit (9.7) pharmDx 5.8 Companion Diagnostics Involving Metabolizing Enzymes 5.8.1 Companions for TMPT, CYP2C9 and UGT1A1 Enzymes 5.8.2 Companions for Aromatase Inhibitors 5.8.3 Companions for Actos and Avandia 5.9 Drivers and Barriers to Companion Diagnostics 5.10 Partnerships with Pharma Companies to Identify Therapeutic Targets 5.11 Circulating Tumor Cell Assay: Prognostic and Predictive Factors for Breast Cancer 5.12 Companion Diagnostics Used by Clinical Service Laboratories 5.13 New Technologies and Products under Development 5.13.1 OncoMethylome (now MDx Health) 5.13.2 Ventana Medical Systems Inks Companion Diagnostic Deal with Syndax for Lung Cancer Drug 5.13.3 Abbott Expands Agreement with GSK to Include Development of a Companion Diagnostic Test for the PRAME Antigen 5.14 Pharmacogenomics Tests 5.14.1 MGMT Methylation Assay 5.14.2 Other Pharmacogenomic Opportunities 5.15 Recurrence Prediction Tests 5.16 Blood-based Technologies 5.16.1 Oncotech 5.17 Monogram Biosciences HIV Personalized Platform 5.18 Wako LBA\AFP Test for Liver Cancer 5.19 Future Developments for Companion Diagnostics 5.20 Drug Response Predictors 6. Business and Regulatory Trends in the Companion Biomarker Testing Sector 6.1 Industry Consolidation 6.2 Breath of Product Offering and Pricing 6.3 Government Regulation of Medical Devices 6.3.1 FDA Guidance on Drug Test Co-development 6.3.2 Device Classes 6.3.3 Investigational Use of IVDMIAs 6.3.4 Post-market Requirements 6.3.5 Voluntary versus Required Submissions 6.3.6 Examples of Recent Voluntary Genomic Data Submissions 6.3.7 FDA Labeling Implications and Rules 6.3.8 Regulatory Activities in Companion Diagnostic Testing Translation of Diagnostic Testing Results into Clinical Practice 6.4 Strategic Business and Marketing Considerations 6.5 Commercial Opportunities in Companion Markers 6.6 Moderators of Growth 6.6.1 Roadblocks to Integrating Companion Biomarkers into Clinical Practice 6.6.2 Management of Targeted Therapeutics by Third-Party Payers 6.7 Biotechnology Industry Trends 6.8 Pharmaceutical Industry Trends 6.9 Acquisition, License Agreement, Partnerships 6.10 Legal Developments 6.11 Sales and Marketing Strategies for Tumor Marker Tests 6.11.1 International Markets 6.11.2 Europe 6.11.3 Central and South America 6.11.4 Asia-Pacific 6.12 Product Commercialization 6.13 Reimbursement 6.14 Self-Referral Rules 6.15 Health Insurance Portability and Accountability Act 6.16 Clinical Laboratory Improvement Amendments (CLIA) 6.17 In Vitro Diagnostic Directive (IVDD) and Medical Device Regulations 6.18 FDA's Quality System Regulation (QSR) 6.19 The FDA's OIVD on IVDMIAs 6.20 FDA's Qualification of Cancer Biomarkers 6.20.1 Regulatory Perspectives of Biomarker Validation 6.21 Genetic Tests and Medical Records 6.21.1 Laws against Genetic Discrimination 6.22 Global Drivers of Clinical Laboratory Testing 6.23 Global Outlook 6.24 Oncology Biomarker Qualification Initiative 6.25 FDA Critical Path 6.25.1 Examples of Drugs being Hindered due to Lack of Compliance with FDA Directives 6.26 Biomarkers and FDA's Voluntary Genomic Data Submission 6.27 From Personalized to Predictive Medicine 6.28 Analysis of Cost-Effectiveness at the Individual Level 6.29 The Patient and Advocate Perspective: An Evolution of Influence 6.30 Real-World Experiences Translating the Vision of Personalized Medicine into Practice 6.30.1 Evolving Business Models in Companion Diagnostics and Personalized Medicine 6.30.2 Current Pharma/Diagnostics Business Model Examples 6.31 Reimbursement and Value Creation 6.32 What is the Role of Governmental Agencies in Driving the Adoption of Companion Diagnostics? 6.33 What is the Role of the Insurance Industry in Driving the Adoption of pharmacogenomics (PGx)? 6.34 What is the Role of the Pharma Industry in Driving the Adoption of PGx? 6.35 FDA Guidance Document on Co-development 6.36 What is the Role of the Diagnostic Industry in Driving the Adoption of PGx? 6.37 What is the Future Role of PBMs in Laboratory Services? 7. Companies Entering the Companion Diagnostics Market 7.1 Industry Overview 7.1.1 20/20 GeneSystems, Inc. 7.1.2 Abbott Molecular, Inc. 7.1.3 Affymetrix, Inc. 7.1.4 Agendia BV 7.1.5 Agensys, Inc. 7.1.6 Agilent Technologies 7.1.7 Almac Group 7.1.8 AMDL, Inc. 7.1.9 Applied Biosystems 7.1.10 Asuragen, Inc. 7.1.11 Aureon Laboratories Corporation 7.1.12 Beckman Coulter, Inc. 7.1.13 Becton, Dickinson and Company (BD) Diagnostics - TriPath 7.1.14 Biocode Hycel 7.1.15 BioCurex, Inc. 7.1.16 Biodesix 7.1.17 Biomarker Technologies, LLC 7.1.18 Biomedical Diagnostics, LLC 7.1.19 Biomerica 7.1.20 bioM?rieux, Inc. 7.1.21 Biomira, Inc. 7.1.22 BioModa, Inc. 7.1.23 Bruker Daltonics 7.1.24 Byk Gulden 7.1.25 Cangen Biotechnologies, Inc. 7.1.26 Caprion Proteomics 7.1.27 Celera Diagnostics 7.1.28 Cepheid, Inc. 7.1.29 Clarient, Inc. 7.1.30 Claros Diagnostics 7.1.31 Clinical Data, Inc.: PGxHealth and Cogenics 7.1.32 Correlogic Systems, Inc. 7.1.33 CytoCore, Inc. (Formerly Known As Molecular Diagnostics, Inc.) 7.1.34 Cytogen Corporation (now EUSA Pharma) 7.1.35 Dako (Formerly DakoCytomation) 7.1.36 DiaDexus 7.1.37 DiagnoCure 7.1.38 DRG International 7.1.39 EDP Biotech Corporation 7.1.40 Eisai Co., Ltd. 7.1.41 Epigenomics 7.1.42 EXACT Sciences Corporation 7.1.43 Exagen Diagnostics 7.1.44 Gene Logic, Inc. 7.1.45 Genesis Genomics, Inc. (now known as Mitomics) 7.1.46 GenMark Diagnostics 7.1.47 Genomic Health 7.1.48 Gen-Probe, Inc. 7.1.49 Health Discovery Corporation 7.1.50 Hologic, Inc. (Formerly Cytyc Corporation) 7.1.51 Ikonisys, Inc. 7.1.52 Illumina 7.1.53 Immunomedics 7.1.54 Incyte 7.1.55 InterGenetics 7.1.56 Ipsogen 7.1.57 Johnson & Johnson 7.1.58 LabCorp 7.1.59 Life Technologies Corporation 7.1.60 Matritech, Inc. 7.1.61 Miraculins 7.1.62 Mitsubishi Kagaku latron 7.1.63 Monogram Biosciences (formerly ViroLogic Inc.) 7.1.64 Myriad Genetics, Inc. 7.1.65 NimbleGen Systems 7.1.66 Northwest Biotherapeutics, Inc. 7.1.67 Novartis MDx 7.1.68 Nycomed 7.1.69 Oncotech, Inc. 7.1.70 Oncothyreon, Inc. (Formerly known as Biomira) 7.1.71 Orion Genomics 7.1.72 Oxford BioTherapeutics (formerly Oxford Genome Sciences) 7.1.73 Panacea Pharmaceuticals, Inc. 7.1.74 Polymedco, Inc. 7.1.75 Power3 Medical Products 7.1.76 Prometheus 7.1.77 Proteome Systems Limited 7.1.78 Qiagen N.V. 7.1.79 Roche Molecular Diagnostics 7.1.80 Sanko Junyaku Co. Ltd. 7.1.81 SensiGen, LLC 7.1.82 Siemens Healthcare Diagnostics, Inc. 7.1.83 SuperArray Bioscience Corporation 7.1.84 Third Wave Technologies, Inc. (now owned by Hologic) 7.1.85 Tosoh Biosciences 7.1.86 TrimGen 7.1.87 Upstream Biosciences, Inc. 7.1.88 Ventana Medical Systems, Inc. 7.1.89 Veridex, LLC 7.1.90 Vermillion, Inc. (Formerly Ciphergen) 7.1.91 Vertex Pharmaceuticals, Inc. Appendix 1: FDA Guidance for Industry: Pharmacogenomic Data Submissions A1.1 Introduction A1.2 Background A1.3 Submission Policy A1.3.1 General Principles A1.3.2 Specific Uses of Pharmacogenomic Data in Drug Development and Labeling A1.3.3 Benefits of Voluntary Submissions to Sponsors and FDA A1.4 Submission of Pharmacogenomic Data A1.4.1 Submission of Pharmacogenomic Data During the IND Phase A1.4.2 Submission of Pharmacogenomic Data to a New NDA, BLA or Supplement A1.4.3 Submission to a Previously Approved NDA or BLA A1.4.4 Compliance with 21 CFR Part 58 A1.4.5 Submission of Voluntary Genomic Data from Application-Independent Research A1.5 Format and Content of a VGDS A1.6 Process for Submitting Pharmacogenomic Data A1.7 Agency Review of VGDSs Appendix 2: FDA Issues Draft Companion Diagnostic Guidance Appendix 3: Histochemical Markers for Cancer Glossary INDEX OF FIGURES Figure 2.1: Personalizing Drug Treatment 18 Figure 2.2: Approaches to Personalized Medicine 19 Figure 2.3: The Phase I and II Processes of Drug Metabolism 22 Figure 2.4: Hepatic Distribution of Human CYP450 23 Figure 2.5: Relative Contribution of CYP450 Enzymes to Drug Metabolism 24 Figure 2.6: Genetic Components Determine Drug Metabolism 24 Figure 2.7: Personalized Medicine Drugs in Development 29 Figure 2.8: Healthcare Value Chain 49 Figure 3.1: From Genetic Content to Personalized Medicine 52 Figure 3.2: Impact of Diagnostic Testing on Healthcare Decision-Making 52 Figure 3.3: Impact of Diagnostic Testing on Healthcare Spending 53 Figure 3.4: Breakout of the Molecular Diagnostics Marketplace 54 Figure 3.5: Molecular Diagnostics Market Segmentation 55 Figure 3.6: Molecular Diagnostics Market Segmentation by Technology 55 Figure 3.7: Market Survey Respondent Demographics 60 Figure 3.8: Breakout of the Respondent Pool by Affiliation 60 Figure 3.9: Segmentation of the Personalized Medicine Market 61 Figure 4.1: Personalized Medicine Market Drivers 63 Figure 4.2: Challenges in the Personalized Medicine Space 64 Figure 5.1: Carcinogenesis is a Multi-Step Process 72 Figure 5.2: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results with IHC 79 Figure 5.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH 79 Figure 7.1: Epigenomics Product Development Pipeline 163 INDEX OF TABLES Table 2.1: Timeline for Development of Companion Diagnostics 19 Table 2.2: Personalized Medicine at the Nexus Point 20 Table 2.3: Percentage of Non-Responders in Various Drug Classes 21 Table 2.4: High-Profile Drug Withdrawals from the Marketplace 21 Table 2.5: Metabolism of Drugs by Hepatic Enzymes 23 Table 2.6: Drug Metabolism Drives Drug Efficacy/Toxicity 25 Table 2.7: Population Frequency of the Various Cytochromes 26 Table 2.8: Selected List of Personalized Medicine Tests 28 Table 2.9: Personalized Medicine and Companion Diagnostics Product Pipeline 30 Table 2.10: Typical Response Rates in Therapeutic Areas 42 Table 2.11: Prevalence of People Taking Medications Metabolized by Liver Enzymes 43 Table 2.12: UGT1A1 Helps to Determine Risks Associated with Irinotecan 45 Table 2.13: Current Product Labels: Enzyme Metabolism 45 Table 3.1: Timeline for Impact of Various Molecular Diagnostics Technologies on Personalized Medicine 56 Table 3.2: Impact of Molecular Diagnostics Technologies on Therapeutic Areas in Personalized Medicine 56 Table 3.3: Challenges of Various Molecular Diagnostics Technology Platforms in Personalized Medicine 57 Table 3.4: FDA Classification of Diagnostics by Risk 59 Table 4.1: Personalized Medicine Industry SWOT Analysis 62 Table 4.2: Market Opportunities in Personalized Medicine 65 Table 4.3: Challenges for Market Adoption of Various Personalized Medicine Tests 66 Table 4.4: Hurdles to Personalized Medicine and Companion Diagnostics Development 67 Table 4.5: Timeline of Impact in Areas of Personalized Medicine 68 Table 4.6: Impact of Personalized Medicine on Various Therapeutic Areas 69 Table 5.1: Potential Benefits of Biomarkers as Companion Diagnostics 74 Table 5.2: Utility of Biomarker as Companion Diagnostics to Drug Development 74 Table 5.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: How to Interpret Test Results 78 Table 5.4: Device Submission Elements for the FDA 87 Table 6.1: List and Discounted Prices for Abbott Tumor Marker Tests 95 Table 6.2: Summary of Biomarker Use in the Commercialization of Novel Oncology Pharmacotherapeutics 123 Table 6.3: Pharmacoeconomic Challenges to the Implementation of Biomarkers as Companion Diagnostic Tests 123 Table 7.1: Major Players in Companion Diagnostics Sector 127 Table 7.2: Opportunities for Biomarkers in Cancer Diagnosis and Treatment 152 Table 7.3: Tumor Diagnosis Immunoassay 161 Table 7.4: Tumor Diagnosis Radioimmunoassay 162 Table 7.5: Summary of Matritech's Product Development Programs 179 Companies Mentioned - 20/20 GeneSystems - Abbott Diagnostics - Affymetrix - Agendia BV - Agensys - Almac Group - AMDL - Arcturus Bioscience - Aureon Biosciences - Beckman Coulter - Biocode S.A. - BioCurex - Biomarker Technologies - Biomedical Diagnostics - Biomerica - bioM?rieux - Biomira - BioModa - Bruker Daltonics - Byk Gulden - Cangen Biotechnologies - Caprion Proteomics - Celera Diagnostics - Cepheid - Claros Diagnostics - Clinical Data: PGxHealth and Cogenics - Ciphergen Biosystems - Clarient - Correlogic Systems - Cytogen - Cytyc Corporation - Dako - DiaDexus LLC - Digene Corporation - DiagnoCure - Diagnostic Systems Laboratories - DRG International - DxS - EDP Biotech - Epigenomics - Exact Sciences Corporation - Exagen Diagnostics - Gene Logic - Genesis Genomics - Genomic Health - Gen-Probe - Health Discovery Corporation - Ikonisys - Immunicon - Immunomedics - Incyte Pharmaceuticals - InterGenetics - Ipsogen - LabCorp - Matritech - Miraculins - Mitsubishi Kagaku Medical - Molecular Diagnostics (CytoCore) - Monogram Biosciences - Myriad Genetics - NimbleGen Systems - Northwest Biotherapeutics - Oncotech - Orion Genomics - Oxford Genome Sciences - Panacea Pharmaceuticals - Perlegen Sciences - Polymedco - Power3 Medical Products - Prometheus - Proteome Systems - Qiagen - Sanko Junyaku - SensiGen - SuperArray Bioscience - Third Wave Technologies - Tosoh Medics - TrimGen - TriPath Imaging - Upstream Biosciences - Ventana Medical Systems - Veridex For more information visit http://www.researchandmarkets.com/research/35n4zz/companion About Research and Markets Research and Markets is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
diaDexus Announces Leadership Changes to Drive and Support Future Growth Potential
Business Wire - Wed Jun 25, 7:30AM CDT
-- Alexander Johnson, formerly of Novartis AG, to Join as President -
2014 Automated Microbiology Market -- A Global Strategic Outlook: Molecular Diagnostics, Microbial Identification, Blood Culture, Urine Screening and Immunodiagnostics
M2 - Tue Feb 18, 8:31AM CST
Research and Markets (http://www.researchandmarkets.com/research/48jvmv/2014_automated) has announced the addition of the "2014 Automated Microbiology Market -- A Global Strategic Outlook: Molecular Diagnostics, Microbial Identification, Antibiotic Susceptibility, Blood Culture, Urine Screening, Immunodiagnostics" report to their offering. '2014 Automated Microbiology Market--A Global Strategic Outlook' is a new seven-country strategic analysis of the major business opportunities emerging in the automated microbiology market during the next five years. The report examines key trends in the U.S., five major European countries (France, Germany, Italy, Spain, UK) and Japan; reviews current and emerging assays; analyzes potential applications of innovative diagnostic technologies; forecasts volume and sales for molecular diagnostic, microbial identification, antibiotic susceptibility, blood culture, urine screening and immunodiagnostic procedures, as well as over 100 infectious disease tests by assay, application, market segment, and country; profiles leading players and potential market entrants; and suggests alternative business expansion strategies for suppliers. This comprehensive seven-country report will assist diagnostics industry executives, as well as companies planning to diversify into the dynamic and rapidly expanding microbiology market, in evaluating emerging opportunities and developing effective business strategies. Worldwide Market Overview - Estimated universe of laboratories performing microbiology testing by country. - Specimen, test volume and sales forecasts by country. Market Segmentation Analysis - Sales and market shares for major suppliers by individual test and country. - Volume and sales forecasts for over 100 infectious disease assays by individual test and country. - Test volume estimates by method (molecular, serology/immunodiagnostics, culture/microscopy). - Review of the market dynamics, trends, structure, size, growth and major suppliers by country Companies Mentioned: - Abbott - Affymetrix - Agilent Technologies - Arca/Nuvelo - Beckman Coulter/Danaher - Becton Dickinson - Biokit - bioMerieux - Bio-Rad - Biotest - Caliper - Cepheid - Decode - Diadexus - Diamedix - DiaSorin - Eiken Chemical - Enzo Biochem - Exact Sciences - Fujirebio/Innogenetics - Hologic/Gen-Probe - Illumina - ID Biomedical/GSK - Kreatech - Li-Cor Biosciences - Life Technology - Lonza - Monogram Biosciences - Myriad Genetics - Nanogen/Elitech - Novartis Diagnostics/Grifols - Orchid CellMark - Ortho-Clinical Diagnostics - Proteome Sciences - Qiagen - Roche - Scienion - Sequenom - SeraCare - Siemens - Sierra Molecular - Shimadzu - Takara Bio - Tecan - Thermo Fisher - Wallac/PE - Wako For more information visit http://www.researchandmarkets.com/research/48..._automated About Research and Markets Research and Markets is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
2014 Analysis of the US Hospital Cancer Diagnostics Market
M2 - Thu Feb 13, 3:25AM CST
Research and Markets (http://www.researchandmarkets.com/research/g5hk8t/2014_analysis_of) has announced the addition of the "2014 Analysis of the US Hospital Cancer Diagnostics Market" report to their offering. This new report contains 533 pages, 43 tables, and presents a comprehensive analysis of the US hospital cancer diagnostics market, including: - Major issues pertaining to the French hospital laboratory practice, as well as key economic, regulatory, demographic, social and technological trends with significant market impact during the next five years. - Mortality statistics and scientific views on the etiology of major types of cancer, e.g., lung, colorectal, breast, prostatic, pancreatic, leukemia, lymphoma, gastrointestinal, bladder, liver, ovarian, testicular, oral, skin and others. - Test volume and sales forecasts for 40 cancer diagnostic procedures performed in French hospitals. - Current instrumentation technologies and feature comparison of leading analyzers. - Sales and market shares of leading suppliers. - Emerging diagnostic technologies and their potential market applications. - Product development opportunities. - Profiles of current and emerging suppliers, including their sales, market shares, product portfolios, marketing tactics, technological know-how, new products in R&D, collaborative arrangements and business strategies. - Business opportunities and strategic recommendations for suppliers. Key Topics Covered: Introduction Worldwide Market and Technology Overview A. Cancer Statistics and Etiology B. Major Current And Emerging Cancer Diagnostic Tests C. Instrumentation Review And Market Needs D. Current and Emerging Technologies US A. Executive Summary B. Business Environment C. Market Structure D. Market Size, Growth and Major Suppliers Major Product Development Opportunities A. Reagent Kits and Test Systems/Panels B. Instrumentation C. Computers, Software and Automation D. Auxiliary Products Design Criteria for Decentralized Testing Products Alternative Market Penetration Strategies A. Internal Development B. Collaborative Arrangements C. University Contracts D. Distribution Strategies 1. Marketing Approaches 2. Product Complexity 3. Customer Preference 4. Established Suppliers 5. Emerging Suppliers 6. Major Types of Distributors 7. Market Segmentation Factor Potential Market Entry Barriers and Risks A. Market Maturity B. Cost Containment C. Competition D. Technological Edge and Limitations E. Patent Protection F. Regulatory Constraints G. Decentralized Testing Market Challenges Companies Mentioned: - Abbott - AdnaGen - Applied Gene Technologies - Arca - Beckman Coulter/Danaher - Becton Dickinson - Biomedical Diagnostics - bioMerieux - Bio-Rad - Cepheid - Correlogic Systems - Dako - Decode - Diadexus - Diagnocure - Diasorin - Eiken Chemical - Enterix - Enzo Biochem - Epigenomics - Exact Sciences - Fujirebio - Gen-Probe - Guided Therapeutics - Hologic - Ipsogen - Kreatech - Kyowa Medex - Life Technologies - Mackay Life Sciences - Myriad Genetics - Nanogen Elitech - OncoLab - Otho-Clinical Diagnostics - Panacea Pharmaceuticals - Polartechnics - Polymedco - PreMD - Qiagen - Radient Pharmaceuticals - Roche - Scienion - Sequenom - Siemens Healthcare - Takara Bio - Targeted Diagnostics & Therapeutics - Tosoh - Veridex - Wako Pure Chemicals - Wallac/PE - Zila For more information visit http://www.researchandmarkets.com/research/g5...nalysis_of
2014 Analysis of the World Cancer Diagnostic Testing Market: Country Segment Forecasts, Market Shares, Emerging Technologies, Competitive Strategies, Growth Opportunities
M2 - Mon Feb 10, 2:54AM CST
Research and Markets (http://www.researchandmarkets.com/research/r66j8d/2014_analysis_of) has announced the addition of the "2014 Analysis of the World Cancer Diagnostic Testing Market: Country Segment Forecasts, Market Shares, Emerging Technologies, Competitive Strategies, Growth Opportunities" report to their offering. This new report contains 1,200 pages, 450 tables and provides forecasts for 40 tumor markers by country and market segment, as well as sales and market shares for reagent and instrument suppliers. The report is available by region, country, section, market segment and individual test: Regions: Global, Europe Countries: France, Germany, Italy, Japan, Spain, UK, USA Sections: Assays, Competitors, Instrumentation, Technologies Market Segments: Hospitals (France, Germany, Italy, Japan, Spain, UK, USA), Personalized Testing Tests: AFP, Beta-2 Microglobulin,CA Tumor Markers, CEA, Cell Surface Markers, Occult Blood, PAP, Pap Smear/HPV, PSA To purchase a DataPack that includes (test volumes, sales forecasts, supplier shares) please E-mail us. Key Topics Covered: Introduction Worldwide Market and Technology Overview A. Cancer Statistics and Etiology B. Major Current And Emerging Cancer Diagnostic Tests C. Instrumentation Review And D. Current and Emerging Technologies Competitive Profiles - Abbott - AdnaGen - Applied Gene Technologies - Arca - Beckman Coulter/Danaher - Becton Dickinson - Bio-Rad - Biomedical Diagnostics - Cepheid - Correlogic Systems - Dako - Decode - Diadexus - Diagnocure - Diasorin - Eiken Chemical - Enterix - Enzo Biochem - Epigenomics - Exact Sciences - Fujirebio - Gen-Probe - Guided Therapeutics - Hologic - Ipsogen - Kreatech - Kyowa Medex - Life Technologies - Mackay Life Sciences - Myriad Genetics - Nanogen Elitech - OncoLab - Otho-Clinical Diagnostics - Panacea Pharmaceuticals - Polartechnics - Polymedco - PreMD - Qiagen - Radient Pharmaceuticals - Roche - Scienion - Sequenom - Siemens Healthcare - Takara Bio - Targeted Diagnostics & Therapeutics - Tosoh - Veridex - Wako Pure Chemicals - Wallac/PE - Zila - bioMerieux For more information visit http://www.researchandmarkets.com/research/r6...nalysis_of About Research and Markets Research and Markets is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
Baytex to Present at CIBC Whistler Institutional Investor Conference
Marketwire Canada - Wed Jan 15, 3:14PM CST
Baytex Energy Corp. (TSX:BTE)(NYSE:BTE) is pleased to announce that James Bowzer, President and Chief Executive Officer, will be presenting at the CIBC Whistler Institutional Investor Conference on Wednesday, January 22, 2014 at 4:00 pm PST (5:00 pm MST) in Whistler, British Columbia. Interested parties can listen to a live webcast and view the presentation slides via the following URL:
Niko Receives Conversion Notice
Marketwire - Thu Jan 09, 5:01PM CST
Niko Resources Ltd. (TSX: NKO) announces that on January 8, 2014, it received a notice of conversion in accordance with the terms of the amended and restated 7% senior unsecured notes due July 13, 2014 (the "Notes"
to convert approximately US$0.25 million of the Notes. The conversion will result in the issuance of 120,904 common shares to a holder of the Notes and the outstanding principal balance of the Notes will be approximately US$8.3 million. Baxano Surgical (BAXS) Jumps: Stock Adds 7.8% - Tale of the Tape
Zacks Equity Research - Zacks Investment Research - Mon Jan 06, 7:51AM CST
Baxano Surgical, Inc. was a big mover last session, as its shares rose almost 8% on the day.
Neogen Acquires Insecticide Maker - Analyst Blog
Zacks Equity Research - Zacks Investment Research - Fri Jan 03, 2:10PM CST
NEOG has a long-term association with Chem-Tech as it has used the latter's Prozap trademark for a number of years for some rodenticides.
EnteroMedics (ETRM) Jumps: Stock Adds 7.8% in Session - Tale of the Tape
Zacks Equity Research - Zacks Investment Research - Fri Jan 03, 8:39AM CST
EnteroMedics Inc. was a big mover last session, as its shares rose almost 8% on the day.
Wright Medical Hits New 52-Week High - Analyst Blog
Zacks Equity Research - Zacks Investment Research - Thu Jan 02, 9:39AM CST
Shares of WMGI closed at $30.71 on the same day, representing a strong one-year return of 46.3%.
Omeros Corp. (OMER) Jumps: Stock Rises 18.1% - Tale of the Tape
Zacks Equity Research - Zacks Investment Research - Thu Dec 19, 7:11AM CST
Omeros (OMER) was a big mover last session, as the company saw its shares rise by over 18% on the day.
2014 Analysis of the UK Hospital Cancer Diagnostics Market Gives Sales Forecasts for 40 Cancer Diagnostic Procedures
M2 - Mon Dec 16, 5:18AM CST
Research and Markets (http://www.researchandmarkets.com/research/5tjpfw/2014_analysis_of) has announced the addition of the "2014 Analysis of the UK Hospital Cancer Diagnostics Market" report to their offering. This new report contains 533 pages, 43 tables, and presents a comprehensive analysis of the UK hospital cancer diagnostics market, including: - Major issues pertaining to the French hospital laboratory practice, as well as key economic, regulatory, demographic, social and technological trends with significant market impact during the next five years. - Mortality statistics and scientific views on the etiology of major types of cancer, e.g., lung, colorectal, breast, prostatic, pancreatic, leukemia, lymphoma, gastrointestinal, bladder, liver, ovarian, testicular, oral, skin and others. - Test volume and sales forecasts for 40 cancer diagnostic procedures performed in French hospitals. - Current instrumentation technologies and feature comparison of leading analyzers. - Sales and market shares of leading suppliers. - Emerging diagnostic technologies and their potential market applications. - Product development opportunities. - Profiles of current and emerging suppliers, including their sales, market shares, product portfolios, marketing tactics, technological know-how, new products in R&D, collaborative arrangements and business strategies. - Business opportunities and strategic recommendations for suppliers. Companies Mentioned: - Abbott - Applied Gene Technologies - Beckman Coulter/Danaher - Becton Dickinson - Biomedical Diagnostics - bioMerieux - Bio-Rad - Cepheid - Correlogic Systems - Dako - Decode - Diadexus - Eiken Chemical - Fujirebio - Gen-Probe - Hologic - Ipsogen - Kreatech - Kyowa Medex - Life Technologies - Mackay Life Sciences - Myriad Genetics - Otho-Clinical Diagnostics - Polymedco - Qiagen - Radient Pharmaceuticals - Roche - Siemens Healthcare - Takara Bio - Targeted Diagnostics & Therapeutics - Tosoh - Veridex - Wako Pure Chemicals - Wallac/PE - Zila For more information visit http://www.researchandmarkets.com/research/5t...nalysis_of About Research and Markets Research and Markets is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
2014 Analysis of CEA Testing Technologies and Emerging Markets Profiles Leading Suppliers and Recent Market Entrants
M2 - Mon Dec 16, 5:13AM CST
Research and Markets (http://www.researchandmarkets.com/research/skd2lp/2014_analysis_of) has announced the addition of the "2014 Analysis of CEA Testing Technologies and Emerging Markets" report to their offering. This report contains 250 pages, 15 tables and presents a detailed analysis of the CEA testing market in the US, Europe (France, Germany, Italy, Spain, UK) and Japan, including clinical significance and current laboratory practice; 5- and 10-year test volume and sales forecasts by country and market segment; as well as sales and market shares for major suppliers. The cancer diagnostics market is on the verge of explosion, as the researchers approach major technological breakthroughs in tumor diagnosis and therapy, discover new specific antigens, and unlock the mystery of the genetic basis of the disease. During the next ten years, the worldwide cancer testing market is promising to be an exciting, dynamic and rapidly expanding field. Anticipated technological breakthroughs will create numerous opportunities for determining genetic predisposition, detecting specific tumors, and monitoring biological response to cancer therapy. The rise in geriatric population will further compound the growing demand for malignancy assays and the rapid market expansion worldwide. The report also examines market applications of DNA probes, biochips/microarrays, monoclonal antibodies, immunoassays, IT, chromosome analysis, and other technologies; reviews features and operating characteristics of automated analyzers; profiles leading suppliers and recent market entrants developing innovative technologies and products; and identifies alternative market penetration strategies and entry barriers/risks. Companies Mentioned: - Abbott - AdnaGen - Applied Gene Technologies - Arca - Beckman Coulter/Danaher - Becton Dickinson - Biomedical Diagnostics - bioMerieux - Bio-Rad - Cepheid - Correlogic Systems - Dako - Decode - Diadexus - Diagnocure - Diasorin - Eiken Chemical - Enterix - Enzo Biochem - Epigenomics - Exact Sciences - Fujirebio - Gen-Probe - Guided Therapeutics - Hologic - Ipsogen - Kreatech - Kyowa Medex - Life Technologies - Mackay Life Sciences - Myriad Genetics - Nanogen Elitech - OncoLab - Ortho-Clinical Diagnostics - Panacea Pharmaceuticals - Polartechnics - Polymedco - PreMD - Qiagen - Radient Pharmaceuticals - Roche - Scienion - Sequenom - Siemens Healthcare - Takara Bio - Targeted Diagnostics & Therapeutics - Tosoh - Veridex - Wako Pure Chemicals - Wallac/PE - Zila For more information visit http://www.researchandmarkets.com/research/sk...nalysis_of About Research and Markets Research and Markets is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
Covidien to Buy GivenImaging, Shares Rise - Analyst Blog
Zacks Equity Research - Zacks Investment Research - Tue Dec 10, 10:10AM CST
The addition of Given Imaging's products to Covidien's portfolio serves its strategy to support physicians with products that range from diagnosis to treatment.
Alere Develops Health Information in U.K. - Analyst Blog
Zacks Equity Research - Zacks Investment Research - Thu Sep 12, 4:50PM CDT
Alere will establish a site in Leeds to support this project.
PerkinElmer Launches SCID Test - Analyst Blog
Zacks Equity Research - Zacks Investment Research - Tue Sep 03, 12:50PM CDT
PerkinElmer is dedicated in offering products and systems for prenatal clinical problems
diaDexus, Inc. Appoints Ralf Schoenbrunner to Senior Vice President, Research and Early Development
Business Wire - Thu Aug 22, 7:00AM CDT
diaDexus, Inc. (OTCQB
DXS), a company developing and commercializing proprietary cardiovascular diagnostic products, today announced that E. Ralf Schoenbrunner, Ph.D. has been appointed to the position of senior vice president of research and early development. Dr. Schoenbrunner has more than 20 years of experience in the medical device and diagnostic field including executing multiple successful product development projects. diaDexus, Inc. Reports Second Quarter 2013 Financial Results
GlobeNewswire - Thu Aug 08, 3:05PM CDT
12th Consecutive Quarter of Year-over-Year Revenue Growth
