Biomerica Inc (BMRA) 0.8600 $BMRA
Biomerica to Supply Its Colorectal Screening Point of Care Test to Multinational Pharmaceutical Company With Over $40 Billion in Sales
Marketwire - Mon Aug 11, 7:19AM CDT
Biomerica, Inc. (OTCBB: BMRA) announced today it will supply its EZ Detect colorectal screening test to a multinational pharmaceutical company that has over $40 billion in revenues and over 70,000 employees worldwide. The EZ Detect product will be sold and marketed by the pharmaceutical company in one European country with the possibility of expanding into multiple other countries throughout Europe. The same pharmaceutical company currently distributes two other Biomerica point of care tests and the colorectal screening test is a new addition to the line. The terms of the agreement were not disclosed and will remain confidential.
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.
AcelRx Pharmaceuticals (ACRX) Jumps: Stock Rises 9.0% - Tale of the Tape
Zacks Equity Research - Zacks Investment Research - Tue Jun 17, 8:18AM CDT
AcelRx Pharmaceuticals, Inc. (ACRX) was a big mover last session, as the company saw its shares rise by almost 9% on the day.
Alcobra Ltd. (ADHD) Jumps: Stock Rises 8.7% - Tale of the Tape
Zacks Equity Research - Zacks Investment Research - Thu Jun 12, 8:18AM CDT
Alcobra Ltd. (ADHD) was a big mover last session, as the company saw its shares rise by roughly 9% on the day.
Global Enteric Disease Testing Market 2014-2018: New Emerging Viruses and Bacteria Playing an Important Role in Diagnostics Industry
M2 - Wed Feb 26, 6:38AM CST
Research and Markets (http://www.researchandmarkets.com/research/lrghlr/global_enteric) has announced the addition of the "Global Enteric Disease Testing Market 2014-2018" report to their offering. The analysts forecast the Global Enteric Disease Testing market to grow at a CAGR of 2.83 percent over the period 2013-2018. One of the key factors contributing to this market growth is the increasing incidence of enteric diseases. The Global Enteric Disease Testing market has also been witnessing the emergence of new pathogens causing infections. However, the stringent regulatory approval could pose a challenge to the growth of this market. Key vendors dominating this space are Alere Inc., bioMerieux SA, Bio-Rad Laboratories Inc., Cepheid Inc. and DiaSorin S.p.A. Other vendors mentioned in the report are Affymetrix Inc., Beckton, Dickenson and Co., Biomerica Inc., Coris BioConcept, Danaher Corp., Meridian Bioscience Inc., Quest Diagnostics Inc., R-Biopharm AG, and Trinity Biotech PLC. Commenting on the report, an analyst from the team said: Vendors are introducing new diagnostic tests for new found pathogens that are responsible for some other types of infectious diseases. These new pathogens include West Nile virus, respiratory syncytial virus, genital mycoplasma, C. difficile, norovirus, and rotavirus. C. difficile and rotavirus tests have seen the maximum level of acceptance in the market. Thus, the improvement in detection technology aiding in the identification of new pathogens is driving the need for enteric disease testing products. According to the report, one of the major drivers in the market is the increasing incidence of enteric diseases among the population, creating a need for testing methods that effectively diagnose diseases. For more information visit http://www.researchandmarkets.com/research/lr...al_enteric 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.
Concise Analysis on the International Enteric Disease Testing Market - Forecasts to 2019
M2 - Wed Feb 05, 5:23AM CST
Research and Markets (http://www.researchandmarkets.com/research/v3x48h/enteric_disease) has announced the addition of the "Concise Analysis on the International Enteric Disease Testing Market - Forecasts to 2019" report to their offering. Various microbes responsible for enteric infections include salmonella, shigella, rotavirus, norovirus, c. difficile, cryptosporidium, vibrio and campylobacter. These diseases may range from asymptomatic to having mild to severe symptoms such as bloody diarrhea, abdominal cramps, stool containing blood or pus, fever and weight loss. Incubation period varies from few days to few weeks depending on the disease and severity. In order to reduce the chance of developing complications, these diseases needed to be diagnosed early. Earlier, diagnosis of enteric diseases relied on culture results of stool specimen that involved identification of causative pathogens in a culture medium. However, the trend is now shifting from culture methods to other diagnostic methods owing to limitations associated with culture tests. Major drawbacks associated with culture tests include high cost, labor intensive, requires sophisticated laboratory and a skilled person to perform the diagnosis. On the other hand, enzyme-linked immunosorbent assay (ELISA) and polymerase chain reaction (PCR) has made enteric infection diagnosis easy and fast. In developed regions such as North America and Europe, PCR based diagnosis is most recommended testing method for enteric diseases as it offers high sensitivity and specificity and is considered as easy, accurate, rapid and reliable method of diagnosis. Latest introductions in MALDI-TOF have also been developed for rapid diagnosis of whole organisms without destruction of infection sample. Asia-Pacific accounting for more than 50% of the total global population represents the most profitable market for enteric disease testing in terms of growth and potential. Key Topics Covered: 1 Preface 2 Executive Summary 3 Enteric Disease Testing Market Overview 4 Global Enteric Disease Testing Market 5 Global Enteric Disease Testing Market, By Geography, 2011 - 2019 6 Key Player Analysis for Enteric Disease Testing Market, 2012 7 Company Profiles Companies Mentioned: - Alere - Becton Dickinson & Company - Biomerica - Biomerieux - Bio-Rad - Cepheid - Coris Bioconcept - Diasorin - Meridian Bioscience - Quest Diagnostics - Trinity Biotech For more information visit http://www.researchandmarkets.com/research/v3...ic_disease
Merriman Capital Initiates on Biomerica, Inc. with a Buy Rating
Thomson Reuters ONE - Fri Jan 24, 9:29AM CST
SAN FRANCISCO - January 24, 2014 - Merriman Capital, Inc. ("Merriman"
, a wholly owned subsidiary of Merriman Holdings, Inc. (OTCQX: MERR), announced that it has initiated equity research coverage of Biomerica, Inc. (OTCQB: BMRA) with a Buy rating and a $2.85 price target.
Biomerica Announces Completion of Strategic Investment
Marketwire - Wed Jan 22, 7:19AM CST
Biomerica, Inc. (OTCBB: BMRA), a global provider of advanced diagnostic products for the early detection of medical conditions, today reported it has closed a strategic investment from its new China distribution partner. In total the new China partner has now invested $500,000 at $1.25 per share for 400,000 shares of Biomerica restricted common stock.
Prefeasibility Report on a Peanut Butter Manufacturing Plant
M2 - Fri Jan 17, 4:31AM CST
Research and Markets (http://www.researchandmarkets.com/research/5kjt3t/prefeasibility) has announced the addition of the "Prefeasibility Report on a Peanut Butter Manufacturing Plant" report to their offering. Prefeasibility Report on a Peanut Butter Manufacturing Plant provides a techno-commercial roadmap for setting up a peanut butter manufacturing plant. The study, which has been done by one of the world's leading research and advisory firms, covers all the requisite aspects of the peanut butter industry. This ranges from macro overview of the market to micro details of the industry performance, processing & manufacturing requirements, project cost, project funding, project economics, expected returns on investment, profit margins, etc. This report is a must-read for entrepreneurs, investors, researchers, consultants, business strategists, and all those who are planning to foray into the peanut butter industry in any manner. Key Questions Answered in This Report? - What are the key success and risk factors in the peanut butter industry? - How has the peanut butter market performed so far and how will it perform in the coming years? - What is the structure of the peanut butter industry and who are the key players? - What are the various unit operations involved in a peanut butter plant? - What is the total size of land required for setting up a peanut butter plant? - What are the machinery requirements for setting up a peanut butter plant? - What are the raw material requirements for setting up a peanut butter plant? - What are the utility requirements for setting up a peanut butter plant? - What are the manpower requirements for setting up a peanut butter plant? - What are the infrastructure costs for setting up a peanut butter plant? - What are the capital costs for setting up a peanut butter plant? - What are the operating costs for setting up a peanut butter plant? - What should be the pricing mechanism of various peanut butter products? - What will be the income and expenditures for a peanut butter plant? - What is the time required to break-even? *Please note that this is a prefeasibility report. It will be delivered to you within 10-12 days after the confirmation of payment Key Topics Covered: 1. Executive Summary 2. Introduction to the Peanut Butter Industry 3. Peanut Butter Industry Analysis 4. Processing & Manufacturing of Peanut Butter Products 5. Project Details, Requirements and Costs Involved 6. Peanut Butter Manufacturing Plant: Loans & Financial Assistance 7. Peanut Butter Manufacturing Plant: Project Economics 8. Appendix For more information visit http://www.researchandmarkets.com/research/5k...easibility 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.
Biomerica Inc falls to net loss of USD243,357 in Q2
M2 - Thu Jan 16, 9:46AM CST
Biomedical company Biomerica Inc (OTCBB:BMRA) on Wednesday reported a net loss of USD243,357, or USD0.03 per share, for the three months ended 30 November 2013.
GKN's Marcus Bryson to become President of UK trade organisation ADS Group
M2 - Wed Jan 15, 9:49AM CST
Aerospace
Biomerica Announces Second Quarter Financial Results
Marketwire - Wed Jan 15, 7:28AM CST
Biomerica, Inc. (OTCBB: BMRA) today reported net sales of $934,841 for the three months ended November 30, 2013, compared to $1,883,771 for the same period in the previous year. Net sales were $1,948,580 for the first six months of fiscal 2014 compared to $3,585,719 for the first six months in fiscal 2013.
10-Q: BIOMERICA INC
Edgar Online - Tue Jan 14, 3:25PM CST
Item 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Biomerica to Supply Two of Its Point of Care Products to Multinational Pharmaceutical Company With Over $40 Billion in Sales
Marketwire - Tue Jan 14, 7:19AM CST
Biomerica, Inc. (OTCBB: BMRA) announced today it will supply two of its point of care products to a multinational pharmaceutical company for distribution in one European country with the possibility of expanding into multiple other countries throughout Europe. In addition, the multinational company is considering distribution of other Biomerica point of care products. The multinational pharmaceutical company that will be distributing Biomerica's products has over $40 billion in revenues and over 70,000 employees worldwide. The terms of the agreement were not disclosed and will remain confidential.
Biomerica Announces Year End Results -- Sales Up Over 6%
Marketwire - Fri Aug 30, 7:19AM CDT
Biomerica, Inc. (OTCBB: BMRA), a global provider of advanced diagnostic products for the early detection of medical conditions, today reported net sales for the fiscal year 2013 were $6,472,960 versus net sales of $6,081,131 in fiscal 2012, an increase of 6.4%. Net cash flow from operating activities was $1,394,037 for fiscal year ended May 31, 2013 compared with $147,412 for the 2012 year end. Income from operations was $514,008 for fiscal 2013 compared to $504,999 for fiscal 2012 reflecting an increase in Research and Development spending of over $111,000 for the current fiscal year compared to the previous year. Net Income was flat at $0.08 per share for the fiscal year ended May 31, 2013 compared to net income of $0.08 per share, in fiscal 2012.
Biomerica Receives Approval to Market Its H. Pylori and PTH Products in Mexico and Appoints New Distributor in Mexico
Marketwire - Wed Aug 07, 7:19AM CDT
Biomerica, Inc. (OTCBB: BMRA) announced today that it has received approval to market and sell its H. Pylori and Parathyroid Hormone (PTH) diagnostic tests in Mexico. The company also announced that it has appointed a new distributor in Mexico with over 35 years of experience and 200 employees overall.
Cancer Diagnostic Testing World Markets 2013
M2 - Tue Apr 30, 11:01AM CDT
Research and Markets has announced the addition of the "Cancer Diagnostic Testing World Markets" report to their offering. Cancer testing is one of the most important growth opportunities for the next three to five years in the diagnostics segment. The National Cancer Institute estimates that about ten million Americans have or have had some form of cancer. Overall costs of the disease are $126 billion annually. Pharmaceutical companies are developing more than 300 new medicines for cancer, some of which are in development for more than one type of the disease, for a total of more than 500 ongoing R&D projects. The goal of this TriMark Publications report is to review the market for tumor marker testing equipment and supplies using screening reagents and instruments for analysis of individual components in blood, serum or plasma. It defines the dollar volume of sales, both worldwide and in the U.S., and analyzes the factors that influence the size and the growth of the market segments. Also examined are t
Biomerica Announces Third Quarter Financial Results
Marketwire - Tue Apr 16, 7:15AM CDT
Biomerica, Inc. (OTCBB: BMRA) today reported net sales of $5,002,418 for the nine months ending February 28, 2013, compared to $4,538,944 for the same period in the previous year, an increase of 10.2%. Sales for the three months ending February 28, 2013 were $1,416,698, compared to $1,514,673, a decrease of $97,975, or 6.5%.
Diabetes Diagnostics - Global Strategic Business Report
M2 - Tue Feb 05, 5:53AM CST
Research and Markets (http://www.researchandmarkets.com/research/dnsz3x/diabetes) has announced the addition of the "Diabetes Diagnostics - Global Strategic Business Report" report to their offering. This report analyzes the worldwide markets for Diabetes Diagnostics in US$ Million by the following Product Segments: - Blood Glucose Testing Devices (Blood Glucose Test Kit, Blood Glucose Meter/Monitor, Diabetes Kit, & Diabetes Tracking System) - Diabetes Testing Supplies (Blood Glucose Test Strips, Lancet, Lancet Device, Reagent Strip) - Others (Including Blood Glucose Sensors, Control Solution, and Reagent Tablets). The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World. Annual estimates and forecasts are provided for the period 2009 through 2017. Also, a six-year historic analysis is provided for these markets. The report profiles 62 companies including many key and niche players. Market data and analytics are derived from
Biomerica to Supply Its Colorectal Screening Point of Care Test to Multinational Pharmaceutical Company With Over $40 Billion in Sales
Marketwire - Mon Aug 11, 7:19AM CDT
Biomerica, Inc. (OTCBB: BMRA) announced today it will supply its EZ Detect colorectal screening test to a multinational pharmaceutical company that has over $40 billion in revenues and over 70,000 employees worldwide. The EZ Detect product will be sold and marketed by the pharmaceutical company in one European country with the possibility of expanding into multiple other countries throughout Europe. The same pharmaceutical company currently distributes two other Biomerica point of care tests and the colorectal screening test is a new addition to the line. The terms of the agreement were not disclosed and will remain confidential.
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.
AcelRx Pharmaceuticals (ACRX) Jumps: Stock Rises 9.0% - Tale of the Tape
Zacks Equity Research - Zacks Investment Research - Tue Jun 17, 8:18AM CDT
AcelRx Pharmaceuticals, Inc. (ACRX) was a big mover last session, as the company saw its shares rise by almost 9% on the day.
Alcobra Ltd. (ADHD) Jumps: Stock Rises 8.7% - Tale of the Tape
Zacks Equity Research - Zacks Investment Research - Thu Jun 12, 8:18AM CDT
Alcobra Ltd. (ADHD) was a big mover last session, as the company saw its shares rise by roughly 9% on the day.
Global Enteric Disease Testing Market 2014-2018: New Emerging Viruses and Bacteria Playing an Important Role in Diagnostics Industry
M2 - Wed Feb 26, 6:38AM CST
Research and Markets (http://www.researchandmarkets.com/research/lrghlr/global_enteric) has announced the addition of the "Global Enteric Disease Testing Market 2014-2018" report to their offering. The analysts forecast the Global Enteric Disease Testing market to grow at a CAGR of 2.83 percent over the period 2013-2018. One of the key factors contributing to this market growth is the increasing incidence of enteric diseases. The Global Enteric Disease Testing market has also been witnessing the emergence of new pathogens causing infections. However, the stringent regulatory approval could pose a challenge to the growth of this market. Key vendors dominating this space are Alere Inc., bioMerieux SA, Bio-Rad Laboratories Inc., Cepheid Inc. and DiaSorin S.p.A. Other vendors mentioned in the report are Affymetrix Inc., Beckton, Dickenson and Co., Biomerica Inc., Coris BioConcept, Danaher Corp., Meridian Bioscience Inc., Quest Diagnostics Inc., R-Biopharm AG, and Trinity Biotech PLC. Commenting on the report, an analyst from the team said: Vendors are introducing new diagnostic tests for new found pathogens that are responsible for some other types of infectious diseases. These new pathogens include West Nile virus, respiratory syncytial virus, genital mycoplasma, C. difficile, norovirus, and rotavirus. C. difficile and rotavirus tests have seen the maximum level of acceptance in the market. Thus, the improvement in detection technology aiding in the identification of new pathogens is driving the need for enteric disease testing products. According to the report, one of the major drivers in the market is the increasing incidence of enteric diseases among the population, creating a need for testing methods that effectively diagnose diseases. For more information visit http://www.researchandmarkets.com/research/lr...al_enteric 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.
Concise Analysis on the International Enteric Disease Testing Market - Forecasts to 2019
M2 - Wed Feb 05, 5:23AM CST
Research and Markets (http://www.researchandmarkets.com/research/v3x48h/enteric_disease) has announced the addition of the "Concise Analysis on the International Enteric Disease Testing Market - Forecasts to 2019" report to their offering. Various microbes responsible for enteric infections include salmonella, shigella, rotavirus, norovirus, c. difficile, cryptosporidium, vibrio and campylobacter. These diseases may range from asymptomatic to having mild to severe symptoms such as bloody diarrhea, abdominal cramps, stool containing blood or pus, fever and weight loss. Incubation period varies from few days to few weeks depending on the disease and severity. In order to reduce the chance of developing complications, these diseases needed to be diagnosed early. Earlier, diagnosis of enteric diseases relied on culture results of stool specimen that involved identification of causative pathogens in a culture medium. However, the trend is now shifting from culture methods to other diagnostic methods owing to limitations associated with culture tests. Major drawbacks associated with culture tests include high cost, labor intensive, requires sophisticated laboratory and a skilled person to perform the diagnosis. On the other hand, enzyme-linked immunosorbent assay (ELISA) and polymerase chain reaction (PCR) has made enteric infection diagnosis easy and fast. In developed regions such as North America and Europe, PCR based diagnosis is most recommended testing method for enteric diseases as it offers high sensitivity and specificity and is considered as easy, accurate, rapid and reliable method of diagnosis. Latest introductions in MALDI-TOF have also been developed for rapid diagnosis of whole organisms without destruction of infection sample. Asia-Pacific accounting for more than 50% of the total global population represents the most profitable market for enteric disease testing in terms of growth and potential. Key Topics Covered: 1 Preface 2 Executive Summary 3 Enteric Disease Testing Market Overview 4 Global Enteric Disease Testing Market 5 Global Enteric Disease Testing Market, By Geography, 2011 - 2019 6 Key Player Analysis for Enteric Disease Testing Market, 2012 7 Company Profiles Companies Mentioned: - Alere - Becton Dickinson & Company - Biomerica - Biomerieux - Bio-Rad - Cepheid - Coris Bioconcept - Diasorin - Meridian Bioscience - Quest Diagnostics - Trinity Biotech For more information visit http://www.researchandmarkets.com/research/v3...ic_disease
Merriman Capital Initiates on Biomerica, Inc. with a Buy Rating
Thomson Reuters ONE - Fri Jan 24, 9:29AM CST
SAN FRANCISCO - January 24, 2014 - Merriman Capital, Inc. ("Merriman"
, a wholly owned subsidiary of Merriman Holdings, Inc. (OTCQX: MERR), announced that it has initiated equity research coverage of Biomerica, Inc. (OTCQB: BMRA) with a Buy rating and a $2.85 price target. Biomerica Announces Completion of Strategic Investment
Marketwire - Wed Jan 22, 7:19AM CST
Biomerica, Inc. (OTCBB: BMRA), a global provider of advanced diagnostic products for the early detection of medical conditions, today reported it has closed a strategic investment from its new China distribution partner. In total the new China partner has now invested $500,000 at $1.25 per share for 400,000 shares of Biomerica restricted common stock.
Prefeasibility Report on a Peanut Butter Manufacturing Plant
M2 - Fri Jan 17, 4:31AM CST
Research and Markets (http://www.researchandmarkets.com/research/5kjt3t/prefeasibility) has announced the addition of the "Prefeasibility Report on a Peanut Butter Manufacturing Plant" report to their offering. Prefeasibility Report on a Peanut Butter Manufacturing Plant provides a techno-commercial roadmap for setting up a peanut butter manufacturing plant. The study, which has been done by one of the world's leading research and advisory firms, covers all the requisite aspects of the peanut butter industry. This ranges from macro overview of the market to micro details of the industry performance, processing & manufacturing requirements, project cost, project funding, project economics, expected returns on investment, profit margins, etc. This report is a must-read for entrepreneurs, investors, researchers, consultants, business strategists, and all those who are planning to foray into the peanut butter industry in any manner. Key Questions Answered in This Report? - What are the key success and risk factors in the peanut butter industry? - How has the peanut butter market performed so far and how will it perform in the coming years? - What is the structure of the peanut butter industry and who are the key players? - What are the various unit operations involved in a peanut butter plant? - What is the total size of land required for setting up a peanut butter plant? - What are the machinery requirements for setting up a peanut butter plant? - What are the raw material requirements for setting up a peanut butter plant? - What are the utility requirements for setting up a peanut butter plant? - What are the manpower requirements for setting up a peanut butter plant? - What are the infrastructure costs for setting up a peanut butter plant? - What are the capital costs for setting up a peanut butter plant? - What are the operating costs for setting up a peanut butter plant? - What should be the pricing mechanism of various peanut butter products? - What will be the income and expenditures for a peanut butter plant? - What is the time required to break-even? *Please note that this is a prefeasibility report. It will be delivered to you within 10-12 days after the confirmation of payment Key Topics Covered: 1. Executive Summary 2. Introduction to the Peanut Butter Industry 3. Peanut Butter Industry Analysis 4. Processing & Manufacturing of Peanut Butter Products 5. Project Details, Requirements and Costs Involved 6. Peanut Butter Manufacturing Plant: Loans & Financial Assistance 7. Peanut Butter Manufacturing Plant: Project Economics 8. Appendix For more information visit http://www.researchandmarkets.com/research/5k...easibility 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.
Biomerica Inc falls to net loss of USD243,357 in Q2
M2 - Thu Jan 16, 9:46AM CST
Biomedical company Biomerica Inc (OTCBB:BMRA) on Wednesday reported a net loss of USD243,357, or USD0.03 per share, for the three months ended 30 November 2013.
GKN's Marcus Bryson to become President of UK trade organisation ADS Group
M2 - Wed Jan 15, 9:49AM CST
Aerospace
Biomerica Announces Second Quarter Financial Results
Marketwire - Wed Jan 15, 7:28AM CST
Biomerica, Inc. (OTCBB: BMRA) today reported net sales of $934,841 for the three months ended November 30, 2013, compared to $1,883,771 for the same period in the previous year. Net sales were $1,948,580 for the first six months of fiscal 2014 compared to $3,585,719 for the first six months in fiscal 2013.
10-Q: BIOMERICA INC
Edgar Online - Tue Jan 14, 3:25PM CST
Item 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Biomerica to Supply Two of Its Point of Care Products to Multinational Pharmaceutical Company With Over $40 Billion in Sales
Marketwire - Tue Jan 14, 7:19AM CST
Biomerica, Inc. (OTCBB: BMRA) announced today it will supply two of its point of care products to a multinational pharmaceutical company for distribution in one European country with the possibility of expanding into multiple other countries throughout Europe. In addition, the multinational company is considering distribution of other Biomerica point of care products. The multinational pharmaceutical company that will be distributing Biomerica's products has over $40 billion in revenues and over 70,000 employees worldwide. The terms of the agreement were not disclosed and will remain confidential.
Biomerica Announces Year End Results -- Sales Up Over 6%
Marketwire - Fri Aug 30, 7:19AM CDT
Biomerica, Inc. (OTCBB: BMRA), a global provider of advanced diagnostic products for the early detection of medical conditions, today reported net sales for the fiscal year 2013 were $6,472,960 versus net sales of $6,081,131 in fiscal 2012, an increase of 6.4%. Net cash flow from operating activities was $1,394,037 for fiscal year ended May 31, 2013 compared with $147,412 for the 2012 year end. Income from operations was $514,008 for fiscal 2013 compared to $504,999 for fiscal 2012 reflecting an increase in Research and Development spending of over $111,000 for the current fiscal year compared to the previous year. Net Income was flat at $0.08 per share for the fiscal year ended May 31, 2013 compared to net income of $0.08 per share, in fiscal 2012.
Biomerica Receives Approval to Market Its H. Pylori and PTH Products in Mexico and Appoints New Distributor in Mexico
Marketwire - Wed Aug 07, 7:19AM CDT
Biomerica, Inc. (OTCBB: BMRA) announced today that it has received approval to market and sell its H. Pylori and Parathyroid Hormone (PTH) diagnostic tests in Mexico. The company also announced that it has appointed a new distributor in Mexico with over 35 years of experience and 200 employees overall.
Cancer Diagnostic Testing World Markets 2013
M2 - Tue Apr 30, 11:01AM CDT
Research and Markets has announced the addition of the "Cancer Diagnostic Testing World Markets" report to their offering. Cancer testing is one of the most important growth opportunities for the next three to five years in the diagnostics segment. The National Cancer Institute estimates that about ten million Americans have or have had some form of cancer. Overall costs of the disease are $126 billion annually. Pharmaceutical companies are developing more than 300 new medicines for cancer, some of which are in development for more than one type of the disease, for a total of more than 500 ongoing R&D projects. The goal of this TriMark Publications report is to review the market for tumor marker testing equipment and supplies using screening reagents and instruments for analysis of individual components in blood, serum or plasma. It defines the dollar volume of sales, both worldwide and in the U.S., and analyzes the factors that influence the size and the growth of the market segments. Also examined are t
Biomerica Announces Third Quarter Financial Results
Marketwire - Tue Apr 16, 7:15AM CDT
Biomerica, Inc. (OTCBB: BMRA) today reported net sales of $5,002,418 for the nine months ending February 28, 2013, compared to $4,538,944 for the same period in the previous year, an increase of 10.2%. Sales for the three months ending February 28, 2013 were $1,416,698, compared to $1,514,673, a decrease of $97,975, or 6.5%.
Diabetes Diagnostics - Global Strategic Business Report
M2 - Tue Feb 05, 5:53AM CST
Research and Markets (http://www.researchandmarkets.com/research/dnsz3x/diabetes) has announced the addition of the "Diabetes Diagnostics - Global Strategic Business Report" report to their offering. This report analyzes the worldwide markets for Diabetes Diagnostics in US$ Million by the following Product Segments: - Blood Glucose Testing Devices (Blood Glucose Test Kit, Blood Glucose Meter/Monitor, Diabetes Kit, & Diabetes Tracking System) - Diabetes Testing Supplies (Blood Glucose Test Strips, Lancet, Lancet Device, Reagent Strip) - Others (Including Blood Glucose Sensors, Control Solution, and Reagent Tablets). The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World. Annual estimates and forecasts are provided for the period 2009 through 2017. Also, a six-year historic analysis is provided for these markets. The report profiles 62 companies including many key and niche players. Market data and analytics are derived from
