| Clinical laboratory testing is generally categorized | | | | 6.7.3 Laboratory Corporation of America 66 |
| as either of two general areas--clinical testing and | | | | 6.7.4 LabCorp’s Growth, 2000-2006 66 |
| anatomical pathology testing. Clinical and anatomical | | | | 6.7.5 Competitive Advantages at Quest and |
| pathology procedures are frequently ordered as | | | | LabCorp 67 |
| part of regular physician office visits and hospital | | | | 6.7.6 National Managed Care Contracts 67 |
| admissions in connection with the diagnosis and | | | | 6.7.7 Billing and Collection Management 68 |
| treatment of illnesses. As such, clinical laboratory | | | | 6.7.8 Lower Reagent and Supply Costs 68 |
| analysis is one of the most important sections of | | | | 6.7.9 Esoteric Testing Capabilities 68 |
| medical care. The purpose of this report is to | | | | 6.7.10 Ability to Invest in Web-Based Connectivity |
| describe the specific segments of the clinical | | | | Solutions 68 |
| laboratory analysis business. The emphasis in this | | | | 6.7.11 Competitive Disadvantages of Quest and |
| review is on those companies that are actively | | | | LabCorp 68 |
| developing and marketing laboratory data for the | | | | 6.7.12 Difficulties with Turnaround Times and Stat |
| clinical setting, including hospitals, independent labs, | | | | Services 69 |
| physician’s offices and miscellaneous clinics. | | | | 6.7.13 Physician-Laboratory Communication 69 |
| This study concentrates on the clinical laboratory | | | | 6.7.14 Specimen Pickup Scheduling Inflexibility 69 |
| industry in the U.S. It defines the dollar volume of | | | | 6.8 Regulation of Clinical Laboratory Operations 70 |
| sales in each major market and analyzes the | | | | 6.8.1 CLIA and State Regulations 70 |
| factors that influence the size and the growth of | | | | 6.8.2 Drug Testing 70 |
| the individual market segments. The study | | | | 6.8.3 Controlled Substances 71 |
| surveys some of the primary companies known | | | | 6.8.4 Medical Waste, Hazardous Waste and |
| to be marketing clinical laboratory data into the | | | | Radioactive Materials 71 |
| market. Each company is discussed in depth with | | | | 6.8.5 FDA 71 |
| a section on the history of the company, the | | | | 6.8.6 Occupational Safety 71 |
| product line, business and marketing analysis, and | | | | 6.8.7 Specimen Transportation 71 |
| a subjective commentary of the position of the | | | | 6.8.8 Corporate Practice of Medicine 71 |
| company in its market. Table of Contents : | | | | 6.9 Hospital Outreach Programs 72 |
| 1. Overview 51.1 Objectives of the Report 5 | | | | 6.10 Supply Chain and GPO Contracting 72 |
| 1.2 Methodology 6 | | | | 6.11 Specialty Labs 72 |
| 1.3 Scope of the Report 7 | | | | 6.12 Expansion of Hospital-Based Labs and Hospital |
| 1.4 Executive Summary 8 | | | | Outreach Programs 73 |
| 2. IVD Clinical Laboratory Market 102.1 | | | | 6.13 Managed Care 73 |
| Introduction 10 | | | | 7. Company Profiles 747.1 ACM Medical |
| 2.2 Key Players for Independent Clinical Labs 11 | | | | Laboratory 74 |
| 2.3 Reimbursement Pressure 11 | | | | 7.2 American Esoteric Laboratories (Sonic |
| 2.4 Medicare Part B Spending Trends 13 | | | | Healthcare) 74 |
| 2.5 Cost of Billing and Average Receipts for | | | | 7.3 American Pathology Partners 74 |
| Commercial Labs 15 | | | | 7.4 AmeriPath (Quest) 75 |
| 2.6 Hospital Outreach Programs 16 | | | | 7.5 ARUP Laboratories 75 |
| 2.7 Criteria for Selection of Lab Services 20 | | | | 7.6 Athena Diagnostics 76 |
| 3. The Clinical Laboratory Testing Market 213.1 U.S. | | | | 7.7 Aurora Diagnostics 76 |
| Market 21 | | | | 7.8 Bio-Reference Laboratories, Inc. 76 |
| 3.1.1 Hospital-based Clinical Laboratories 23 | | | | 7.9 BioTech Labs 77 |
| 3.1.2 Commercial Clinical Laboratory Testing 23 | | | | 7.10 CBLPath 77 |
| 3.1.3 Physician Office Laboratories (POLs) 24 | | | | 7.11 Centrex Clinical Laboratories 77 |
| 3.2 Clinical Lab Testing Key Players 29 | | | | 7.12 Clarient, Inc. 77 |
| 3.2.1 Commercial Clinical Labs 29 | | | | 7.13 Clinical Laboratories of Hawaii (Sonic |
| 3.2.2 Hospital Lab Collaborative Ventures 30 | | | | Healthcare) 78 |
| 3.2.3 Specialty Labs 31 | | | | 7.14 Clinical Reference Laboratory 78 |
| 3.3 Revenue and Reimbursement 32 | | | | 7.15 Clongen Laboratories 78 |
| 3.4 Outlook for Clinical Laboratory Testing 35 | | | | 7.16 CompuNet Clinical Laboratories 78 |
| 3.4.1 Long-Term Changes 35 | | | | 7.17 Diagnostic Systems Laboratories 79 |
| 3.4.2 Market Drivers 36 | | | | 7.18 Enzo Biochem, Inc. 79 |
| 3.4.3 The Limits to Growth 37 | | | | 7.19 Esoterix 79 |
| 3.4.4 Key Technologies 37 | | | | 7.20 Focus Diagnostics 80 |
| 3.4.5 Conclusion 38 | | | | 7.21 Fresenius Medical Care AG & Co. KGaA |
| 4. Hot Sectors in the Clinical Lab Testing Market | | | | 80 |
| 394.1 Workplace Drugs-of-Abuse Testing 39 | | | | 7.22 Geneva Laboratories 81 |
| 4.2 Clinical Toxicology 39 | | | | 7.23 Genomic Health, Inc. 81 |
| 4.3 Clinical Testing for the Pharmaceutical Industry | | | | 7.24 Genzyme 82 |
| 40 | | | | 7.25 IBT Laboratories 83 |
| 4.4 Heavy Metal, Trace Element, and Solvent | | | | 7.26 Integrated Regional Laboratories (IRL) 84 |
| Analyses 40 | | | | 7.27 LabCorp 84 |
| 4.5 Diabetes (Glucose) Testing 40 | | | | 7.28 MDS Diagnostic Services 85 |
| 4.6 Molecular Diagnostic Testing 40 | | | | 7.29 MEDTOX Scientific, Inc. 86 |
| 4.7 Cardiac Markers 41 | | | | 7.30 Meriter Health Services 86 |
| 4.8 Blood Bank Screening 41 | | | | 7.31 Mid America Clinical Laboratories (MACL) 86 |
| 4.9 Genetic Testing 41 | | | | 7.32 Monogram Biosciences, Inc. 86 |
| 4.10 Predictive Medicine Testing 42 | | | | 7.33 Myriad Genetics, Inc. 87 |
| 4.11 Personalized Medicine 44 | | | | 7.34 National Jewish Medical and Research Center |
| 4.12 Cancer Testing 44 | | | | 87 |
| 4.13 Cell Based Cancer Testing 45 | | | | 7.35 Parkway Clinical Laboratories 88 |
| 4.14 Monitoring Technologies 47 | | | | 7.36 Pathology Associates Medical Laboratories |
| 4.15 Anatomic Pathology 48 | | | | (PAML) 88 |
| 5. Important Technology Trends 495.1 Technology | | | | 7.37 Psychemedics Corporation 88 |
| Platform Innovations in Point-of-Care Testing 49 | | | | 7.38 Quest Diagnostics Incorporated 88 |
| 5.2 The New Paradigm 49 | | | | 7.39 RDL Reference Laboratory 89 |
| 5.3 Consolidated Workstations 49 | | | | 7.40 Satellite Laboratory Services 89 |
| 5.4 Automation in the Laboratory 51 | | | | 7.41 Spectrum Laboratory Network 89 |
| 5.5 Laboratory Information Systems 52 | | | | 7.42 Sonic Healthcare 90 |
| 5.6 New User-friendly Interface 52 | | | | 8. Clinical Laboratory Testing Sector Trends and |
| 5.7 Data-Management Issues 53 | | | | Forecasts 918.1 Home Care Analysis 91 |
| 5.7.1 Wireless LANs 53 | | | | 8.2 Non-Traditional Collection for Laboratory |
| 5.7.2 Data and Workflow Management Systems | | | | Testing 91 |
| 54 | | | | 8.3 New Systems for Critical-Care and |
| 5.7.3 Beckman Central Command 54 | | | | Near-Patient Testing 91 |
| 5.7.4 Clinical IT More Widely Available in Physician | | | | 8.4 Shift to Preventative Medicine 91 |
| Practices 55 | | | | 8.5 Mergers of Diagnostic Companies 91 |
| 5.7.5 Physician Electronic Health Records (EHRs) 56 | | | | 8.6 Information Management Advances 91 |
| 5.7.6 Specimen Tracking and Processing 56 | | | | 8.7 Test Ordering Patterns 91 |
| 6. Business Trends in the Clinical Laboratory | | | | 8.8 Patient Satisfaction 91 |
| Analyzer Sector 576.1 Key Developments 57 | | | | 8.9 Move Away from Central Laboratory 92 |
| 6.2 Sector Consolidation 57 | | | | 8.10 Healthcare Cost Controls 92 |
| 6.3 Acquisition Pricing 58 | | | | 8.11 Competition for Services 92 |
| 6.4 A Closer Look at Recent Lab Deals 59 | | | | 8.12 Drivers and Barriers of Clinical Laboratory |
| 6.5 Acquisition, License Agreements, Internal | | | | Testing 92 |
| Development and Partnerships 60 | | | | 8.13 Confluence of New Technology 93 |
| 6.6 Merger, Acquisition, Financing and Partnering | | | | 8.14 New Trends in Clinical Laboratory Testing 93 |
| Activities in the Clinical Lab Industry 61 | | | | 8.14.1 Trends in Reimbursement Practices 93 |
| 6.7 Comparison of Quest and LabCorp 65 | | | | 8.14.2 Managed Care 95 |
| 6.7.1 Acquisitions 65 | | | | 8.14.3 Point of Care Testing 96 |
| 6.7.2 Quest’s Growth, 2000-2006 65 | | | | 8.14. |