Who's Doing What in Molecular Diagnostics? - The Results of the Kalorama Information/Emmes Group Survey of U.S. Laboratories

Table of Contents

CHAPTER ONE: EXECUTIVE SUMMARY

• Background
• Objectives of the Report
• Scope of the Report
• Methodology and Limitations of the Report
• Survey Findings

CHAPTER TWO: OVERVIEW OF THE U.S. MARKET FOR SELECTED MOLECULAR TESTS, 2008

• Introduction
• Overview of Company Market Share
  • Abbott Diagnostics
  • Access Genetics, LLC
  • BD Diagnostics/GeneOhm
  • bioMerieux
  • Cepheid
  • Gen-Probe Inc
  • Luminex Corp
  • Prodesse, Inc.
  • Qiagen/Digene
  • Roche Diagnostics
  • Siemens Healthcare Diagnostics
  • Third Wave Technologies Inc
• Overview of the Market: Volume of Tests by Respondent
• Overview of the Market: Reagent Type
  • Commercial, ASR, Homebrew
• Overview of the Market: Type of Lab
• Overview of the Market: Type of Institution
• Market Potential
• Explanation of Quantitative Data Extrapolation Formula

CHAPTER THREE: QUANTITATIVE REVIEW OF THE U.S. MARKET FOR MOLECULAR CHLAMYDIA AND GONORRHEA TESTS

• Background
• Market Breakdown: Vendor Market Share by End User
• Market Breakdown by Type of Test Reagents Used
• Market Breakdown by Lab Type
• Summary and Conclusion
  • Anticipated Growth of the Market

CHAPTER FOUR: QUANTITATIVE REVIEW OF THE U.S. MARKET FOR MOLECULAR HEPATITIS C TESTS: HCV VIRAL LOAD, HCV GENOTYPING

• Background
• Hepatitis C Viral Load
  • Vendor Market Share by End User
  • Market Breakdown by Type of Test Reagents Used
  • Market Breakdown by Lab Type
• Hepatitis C Genotyping
  • Vendor Market Share by End User
  • Market Breakdown by Type of Reagents Used
  • Market Breakdown by Lab Type
• Summary and Conclusion

CHAPTER FIVE: QUANTITATIVE REVIEW OF THE U.S. MARKET FOR MOLECULAR HEPATITIS B VIRAL LOAD TESTS

• Background
• Vendor Market Share by End User
• Market Breakdown by Type of Test Reagents Used
• Market Breakdown by Lab Type
• Summary and Conclusion

CHAPTER SIX: QUANTITATIVE REVIEW OF THE U.S. MARKET FOR MOLECULAR HIV TESTS: HIV VIRAL LOAD AND HIV GENOTYPING

• Background
• HIV Viral Load Testing
  • Vendor Market Share by End User
  • Market Breakdown by Type of Test Reagents Used
  • Market Breakdown by Lab Type
• HIV Genotyping
  • Vendor Market Share by End User
  • Market Breakdown by Type of Test Reagents Used
  • Market Breakdown by Lab Type
• Summary and Conclusion

CHAPTER SEVEN: QUANTITATIVE REVIEW OF THE U.S. MARKET FOR MOLECULAR HPV TESTS: HPV, HPV GENOTYPING

• Background
• Human Papillomavirus (HPV)
  • Vendor Market Share by End User
  • Market Breakdown by Type of Test Reagents Used
• HPV Genotyping
• Summary and Conclusion

CHAPTER EIGHT: QUANTITATIVE REVIEW OF THE U.S. MARKET FOR HOSPITAL AQUIRED INFECTION TESTS: MOLECULAR MRSA AND VRE TESTS

• Background
• Methicillin-Resistant Staphylococcus aureus (MRSA)
  • Vendor Market Share by End User
  • Market Breakdown by Type of Test Reagents Used
  • Market Breakdown by Lab Type
• Vancomycin Resistant Enterocci (VRE)
• Summary and Conclusion

CHAPTER NINE: QUANTITATIVE REVIEW OF THE U.S. MARKET FOR COAGULATION GENE MARKER TESTS: FACTOR II PROTHROMBIN, FACTOR V LEIDEN, AND MTHFR

• Background
• Factor V Leiden
  • Vendor Market Share by End User
  • Market Breakdown by Type of Test Reagents Used
• Factor II Prothrombin
  • Vendor Market Share by End User
  • Market Breakdown by Type of Test Reagents Used
• MTHFR (5,10-Methylenetetrahydrofolate Reductase)
  • Vendor Market Share by End User
  • Market Breakdown by Type of Test Reagents Used
• Summary and Conclusion

CHAPTER TEN: QUANTITATIVE REVIEW OF THE U.S. MARKET FOR MOLECULAR HERPES SIMPLEX VIRUS (HSV TEST)

• Background
• Vendor Market Share by End User
  • Market Breakdown by Type of Test Reagents Used
• Summary and Conclusion

CHAPTER ELEVEN: QUALITATIVE REVIEW OF THE U.S. MARKET FOR MOLECULAR ONCOLOGY TESTS: BCR/ABL, BLADDER CANCER, AND HER2NEU

• Background
• BCR/ABL
• Her-2/Neu
• Bladder Cancer
• Summary, and Conclusion

CHAPTER TWELVE: QUALITATIVE REVIEW OF THE U.S. MARKET FOR TISSUE TYPING TESTS - HLA

• Background
• Findings, Summary and Conclusion

CHAPTER THIRTEEN: QUALITATIVE REVIEW OF THE U.S. MARKET FOR MOLECULAR TESTS FOR INHERITED DISEASES: CYSTIC FIBROSIS (CF) AND FRAGILE X SYNDROME

• Background
• Cystic Fibrosis (CF)
• Fragile X
• Summary and Conclusion

CHAPTER FOURTEEN: QUALITATIVE REVIEW OF THE U.S. MARKET FOR MOLECULAR TESTS FOR RESPIRATORY INFECTIONS: INFLUENZA A/B, GROUP A STREP, MTB (TUBERCULOSIS), BORDETELLA PERTUSSIS, ADENOVIRUS, AND RESPIRATORY VIRUS

• Background
• Market Breakdown by Vendor Market Share
• Summary and Conclusion

CHAPTER FIFTEEN: QUALITATIVE REVIEW OF THE U.S. MARKET FOR MOLECULAR TESTS FOR COMMUNICABLE DISEASES: CMV (CYTOMEGALOVIRUS), EBV (EPSTEIN-BARR VIRUS), GROUP B STREP, AND ENTEROVIRUS

• Background
• Market Breakdown by Vendor Market Share
• Summary and Conclusion

APPENDIX A: TESTS MOST DESIRED BY RESPONDENTS

• If current limitations or barriers did not exist, what are the three molecular tests that your lab would most like to add to its test menu in the next year?

APPENDIX B: TESTS LABS WILL ADD TO TEST MENU

• Q: Is your lab seriously considering adding to its test menu in the next year or two?

APPENDIX C: TESTS REQUESTED THAT LAB CANNOT OFFER

• Q: Are there any molecular tests for which your lab receives more than a few rare requests that you do not currently offer? If yes, which tests?

LIST OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY

• Table 1-1: Respondents Compared to Broader Universe of Labs
• Figure 1-1: Respondent Breakdown (Refence Labs, Public Labs, Hospital Labs)
• Table 1-2: Respondents by Type of Lab, All Institutions (Microbiology, Molecular, Central/Core, Virology, Chemistry/Clin Chem, Immunology, Anatomical Pathology, Genetics, Serology, Cytology, Hematology)
• Table 1-3: Database Respondents by Hospital Bed Size

CHAPTER TWO: OVERVIEW OF THE U.S. MARKET FOR SELECTED MOLECULAR TESTS, 2008

• Table 2-1: Worldwide Molecular Test Revenues of Selected IVD Vendors 2005- 2007
• Table 2-2: Company Data Summary (Number of Analytes Reported, Volume of Tests Reported, Percentage of Tests Reported, Tests per Analyte, Number of Respondents, Percentage of Respondents, Tests per Respondent)
• Table 2-3: Volume of Tests by Analyte (Annual Volume, Volume per Respondent, Number of Respondents, Percent Respondents)
• Table 2-4: Reagent Type (Commercial, ASR, Homebrew) by Analyte
• Table 2-5: Respondents by Type of Lab (Microbiology, Molecular, Central/Core, Virology, Chemistry/Clinical Chemistry, Immunology, Anatomic Pathology, Genetics, Cytology, Serology, Hematology, Other)
• Table 2-6: Analyte Testing Volume by Bed Size of Hospital and All Non-Hospital Labs (Ref Lab)
• Table 2-7: Distribution of Analyte Testing Bed Size of Hospital and All Non- Hospital Labs (Ref Lab)
• Table 2-8: Number of Respondent Labs Running Tests by Analyte and Bed Size of Hospital and All Non Hospital Labs (Ref Lab)
• Table 2-9: Percentage of Respondent Labs Running Tests by Analyte and Bed Size of Hospital and All Non Hospital Labs (Ref Lab)
• Table 2-10: Average Number of Tests per Year by Analyte and Bed Size of Hospital and All Non Hospital Labs (Ref Lab)
• Table 2-11: Most Cited Wish List Tests
• Table 2-12: Most Cited Tests Likely Added to the Test Menu
• Table 2-13: Tests Most Often Not Performed
• Table 2-14: Top 8 Reasons for Not Offering Molecular Tests

CHAPTER THREE: QUANTITATIVE REVIEW OF THE U.S. MARKET FOR MOLECULAR CHLAMYDIA AND GONORRHEA TESTS

• Table 3-1: Selected Molecular CT/GC Tests and Systems Available in the U.S. (Company, Test)
• Table 3-2: Average Number of CT/GC Molecular Tests per Year by Vendor and by End User (Hospitals by Bed Size, Ref Labs, and Totals)
• Table 3-3: Distribution of CT/GC Molecular Test Volume by Vendor and End User (Hospitals by Bed Size, Ref Labs, and Totals)
• Table 3-4: Number of Respondent Labs Using CT/GC Molecular Tests by Vendor and End User(Hospitals by Bed Size, Ref Labs, and Totals)
• Table 3-5: Breakdown of CT/GC Molecular Tests by Vendor and End User (Hospitals by Bed Size, Ref Labs)
• Table 3-6: Breakdown of CT/GC Molecular Tests by Vendor and End User (Hospitals by Bed Size, Ref Labs)
• Table 3-7: Number of Respondents Who Use Homebrew CT/GC Molecular Tests by Size of Hospital and All Non-Hospital Labs (Ref Lab)
• Table 3-8: Test Volume of Homebrew CT/GC Molecular Tests by Size of Hospital and All Non-Hospital Labs (Ref Lab)
• Table 3-9: Breakdown of CT/GC Molecular Tests by Lab Type (Microbiology, Molecular, Core Lab, Virology, Chemistry, Immunology, Serology, Other): Number of Respondents and Total Testing Volume
• Table 3-10: Breakdown of CT/GC Molecular Testing in Core Labs and Chemistry Labs by Hospital Bed Size or Ref Labs
• Table 3-11: Technology Change Responses

CHAPTER FOUR: QUANTITATIVE REVIEW OF THE U.S. MARKET FOR MOLECULAR HEPATITIS C TESTS: HCV VIRAL LOAD, HCV GENOTYPING

• Table 4-1: Selected HCV Tests and Systems Available in the United States
• Table 4-2: Number of HCV Viral Load Tests by Vendor and End User (Hospitals by Bed Size, Ref Labs)
• Table 4-3: Percentage of Respondents Using HCV Viral Load Tests by Vendor and End User (Hospitals by Bed Size, Ref Labs)
• Table 4-4: Number of Respondents Using HCV Viral Load Tests by Vendor and End User (Hospitals by Bed Size, Ref Labs)
• Table 4-5: Distribution of Respondents Reporting HCV Viral Load Tests by Vendor and End User (Hospitals by Bed Size, Ref Labs)
• Table 4-6: Number of HCV Viral Load Tests by Vendor and End User (Hospitals by Bed Size, Ref Labs)
• Table 4-7: Number of Respondents and Test Volume of Labs Using ASRs for HCV Viral Load by End User (Hospitals by Bed Size and All Non-Hospital Labs [Ref Lab])
• Table 4-8: Number of Respondents and Test Volume for HCV Viral Load Testing by Lab Type (Molecular, Microbiology, Virology, Core Lab, Immunology, Chemistry, Serology, Other)
• Table 4-9: Respondents, Test Volume, and Average Number of Tests for HCV Viral Load Testing by Lab Type (Molecular, Microbiology, Virology, Core Lab, Immunology, Chemistry, Serology, Other)
• Table 4-10: Number of HCV Genotyping Tests by Vendor and End User (Hospitals by Bed Size, Ref Labs)
• Table 4-11: Distribution of HCV Genotyping Tests by Vendor and End User (Hospitals by Bed Size, Ref Labs)
• Table 4-12: Number of Respondents Using HCV Genotyping Tests by Vendor and End User (Hospitals by Bed Size, Ref Labs)
• Table 4-13: Distribution of Respondents Using HCV Genotyping Tests by Vendor and End User (Hospitals by Bed Size, Ref Labs)
• Table 4-14: Selected HCV Genotyping Products Available in the United States
• Table 4-15: Number of HCV Viral Load Tests by Vendor and End User (Hospitals by Bed Size, Ref Labs)
• Table 4-16: Number of Respondents Performing HCV Viral Load Tests by Type of Reagents (Commercial Test, ASR, Homebre) by Vendor
• Table 4-17: Number of Respondents and Testing Volume of HCV Genotyping Tests by Lab Type (Molecular, Microbiology, Virology, Other)
• Table 4-18: Respondents, Test Volume, and Average Number of Tests for HCV Genotype Testing by Lab Type (Molecular, Microbiology, Virology, Other)
• Table 4-19: Number Respondents Using HCV Viral Load AND Genotype Tests by Vendor (Abbott, ABI-700, Roche, Siemens, PCR)

CHAPTER FIVE: QUANTITATIVE REVIEW OF THE U.S. MARKET FOR MOLECULAR HEPATITIS B VIRAL LOAD TESTS

• Table 5-1: Selected Molecular HBV Tests and Systems Available in the United States
• Table 5-2: Number of HBV Viral Load Tests by Vendor and End User (Hospitals by Bed Size, Ref Labs)
• Table 5-3: Distribution of Respondents Reporting HBV Viral Load Test Use by Vendor and End User (Hospitals by Bed Size, Ref Labs)
• Table 5-4: Number of Respondents Using HBV Viral Load Tests by Vendor (Roche, Siemens, Digene, Other) and End User (Hospitals by Bed Size, Ref Labs)
• Table 5-5: Percent of Respondents Using HBV Viral Load Tests by Vendor (Roche, Siemens, Digene, Other) and End User (Hospitals by Bed Size, Ref Labs)
• Table 5-6: Number of HBV Viral Load Tests by Vendor (Roche, Digene, Siemens, Other) and End User (Hospitals by Bed Size, Ref Labs)
• Table 5-7: Number and Distribution of Respondents Reporting Use of HBV Viral Load Tests by Vendor (Roche, Siemens, Abbott, Qiagen, Digene, PCR) and Type of Reagents (Commercial, ASR, Homebrew)
• Table 5-8: Testing Volume and Number of Respondents Using HBV Viral Load Tests by Lab Type (Molecular, Microbiology, Virology, Other)
• Table 5-9: Breakdown of HBV Viral Load Tests by Lab Type (Molecular, Microbiology, Virology, Other): Number of Respondents, Total Testing Volume, and Average Number of Tests

CHAPTER SIX: QUANTITATIVE REVIEW OF THE U.S. MARKET FOR MOLECULAR HIV TESTS: HIV VIRAL LOAD AND HIV GENOTYPING

• Table 6-1: Selected FDA Cleared Molecular HIV Tests Available in the United States
• Table 6-2: Number of HIV Viral Load Tests by Vendor (Roche, Siemens, Abbott, bioMerieux, PCR) and End User (Hospitals by Bed Size, Ref Labs)
• Table 6-3: Distribution of HIV Viral Load Testing by Vendor (Roche, Siemens, Abbott, bioMerieux, PCR) and End User (Hospitals by Bed Size, Ref Labs)
• Table 6-4: Number of Respondents Using HIV Viral Load Tests by Vendor (Roche, Siemens, Abbott, bioMerieux, PCR) and End User (Hospitals by Bed Size, Ref Labs)
• Table 6-5: Distribution of Respondents Using HIV Viral Load Tests by Vendor (Roche, Siemens, Abbott, bioMerieux, PCR) and End User (Hospitals by Bed Size, Ref Labs)
• Table 6-6: Number of HIV Viral Load Tests by Vendor by Vendor (Roche, Siemens, Abbott, bioMerieux, PCR) and End User (Hospitals by Bed Size, Ref Labs)
• Table 6-7: Number of Respondents Reporting Use of HIV Viral Load Tests by Type of Reagents Used (Commercial Test, ASR, Homebrew)
• Table 6-8: Number of Respondents and Total Test Volume of HIV Viral Load Tests by Lab Type (Molecular, Microbiology, Virology, Core/Chemistry, Other)
• Table 6-9: Total Testing Volume of HIV Viral Load Tests and Average Number of Tests by Lab Type (Molecular, Microbiology, Virology, Core/Chemistry, Other)
• Table 6-10: Number of HIV Genotyping Tests by Vendor (Roche, Siemens, Abbott, Other) and End User (Hospitals by Bed Size, Ref Labs)
• Table 6-11: Distribution (Share) of Genotyping Tests by Vendor (Roche, Siemens, Abbott, Other) and End User (Hospitals by Bed Size, Ref Labs)
• Table 6-12: Number Respondents Using of HIV Genotyping Tests by Vendor (Roche, Siemens, Abbott, Other) and End User (Hospitals by Bed Size, Ref Labs)
• Table 6-13: Distribution of Respondents Using of HIV Genotyping Tests by Vendor (Roche, Siemens, Abbott, Other) and End User (Hospitals by Bed Size, Ref Labs)
• Table 6-14: Average Number of HIV Genotype Tests by Vendor (Roche, Siemens, Abbott, Other) and End User (Hospitals by Bed Size, Ref Labs)
• Table 6-15: Number of Respondents Using HIV Viral Load Tests by Type or Reagent (Commercial, ASR, Homebrew)
• Table 6-16: Number of Respondents, Total Testing Volume, and Average Numer of Tests of HCV Genotyping Tests by Lab Type
• Table 6-17: Number Respondents Using HIV Viral Load AND Genotype Tests by Vendor (Abbott, Roche, Siemens, PCR)

CHAPTER SEVEN: QUANTITATIVE REVIEW OF THE U.S. MARKET FOR MOLECULAR HPV TESTS: HPV, HPV GENOTYPING

• Table 7-1: Selected Molecular HPV Tests
• Table 7-2: Number of HPV Tests by Vendor (Qiagen/Digene, Hologic/Third Wave, Other) and End User (Hospital Lab by Bed Size, Ref Lab)
• Table 7-3: Distribution of HPV Tests by Vendor (Qiagen/Digene, Hologic/Third Wave, Other) and End User (Hospital Lab by Bed Size, Ref Lab)
• Table 7-4: Number of Respondents Using HPV Tests by Vendor (Qiagen/Digene, Hologic/Third Wave, Other) and End User (Hospital Lab by Bed Size, Ref Lab)
• Table 7-5: Distribution of HPV Tests by Vendor (Qiagen/Digene, Hologic/Third Wave, Other) and End User (Hospital Lab by Bed Size, Ref Lab)
• Table 7-6: Average Number of HPV Tests Performed by Vendor (Qiagen/Digene, Hologic/Third Wave, Other) and End User (Hospital Lab by Bed Size, Ref Lab)
• Table 7-7: Number of Repondents Using HPV Tests by Vendor (Access Genetics, Cepheid, Qiagen/Digene, Roche, Siemens, Hologic/Third Wave, PCR) and Type of Reagent (Commercial, ASR, Homebrew)
• Table 7-8: Number of Respondents Using HPV Genotyping Tests by Vendor and Lab Type (Hospital vs Reference)
• Table 7-9: Number of HPV Genotyping Tests Performed by Vendor and Lab Type (Hospital vs Reference)

CHAPTER EIGHT: QUANTITATIVE REVIEW OF THE U.S. MARKET FOR HOSPITAL AQUIRED INFECTION TESTS: MOLECULAR MRSA AND VRE TESTS

• Table 8-1: Percentage of Staph Infections among U.S. Intensive Care Patients That Are Infected with MRSA
• Table 8-2: Selected Molecular MRSA Tests and Systems Available in the U.S.
• Table 8-3: Number of Molecular MRSA Tests by Vendor (BD/Gene Ohm, Cepheid, Roche, Other) and End User (Hospitals by Bed Size, Ref Lab)
• Table 8-4: Distribution ofMolecular MRSA Test Volume by Vendor (BD/GeneOhm, Cepheid, Roche, Other) and End User (Hospitals by Bed Size, Ref Lab)
• Table 8-5: Number of Respondents Using Molecular MRSA Tests by Vendor (BD/GeneOhm, Cepheid, Roche, Other) and End User (Hospitals by Bed Size, Ref Lab)
• Table 8-6: Distribution of Respondents Using Molecular MRSA Tests by Vendor (BD/GeneOhm, Cepheid, Roche, Other) and End User (Hospitals by Bed Size, Ref Lab)
• Table 8-7: Average Number of Molecular MRSA Tests by Vendor (BD/GeneOhm, Cepheid, Roche, Other) and End User (Hospitals by Bed Size, Ref Lab) and End User
• Table 8-8: Number of Respondents Using MRSA Tests by Vendor (BD/GeneOhm, Cepheid, Roche, Other, PCR) and Type of Reagents (Commercial, ASR, Homebrew)
• Table 8-9: Number of Respondents and Total Testing Volume of MRSA Tests by Lab Type (Microbiology, Molecular, Core/Chem Lab, Virology, Other)
• Table 8-10: Average Number of MRSA Tests Run by Lab Type (Microbiology, Molecular, Core Lab, Virology, Other)
• Table 8-11: Number of Respondents and Testing Volume of VRE Tests by Vendor in Hospital Labs

CHAPTER NINE: QUANTITATIVE REVIEW OF THE U.S. MARKET FOR COAGULATION GENE MARKER TESTS: FACTOR II PROTHROMBIN, FACTOR V LEIDEN, AND MTHFR

• Table 9-1: FDA-Cleared Molecular Coagulation Factor Tests
• Table 9-2: Number of Factor V Molecular Tests by Vendor (Roche, Third Wave, Nanosphere, Other) and End User (Hospitals by Bed Size, Ref Lab)
• Table 9-3: Distrubution of Factor V Molecular Test Volume by Vendor (Roche, Third Wave, Nanosphere, Other) and End User (Hospitals by Bed Size, Ref Lab)
• Table 9-4: Number of Respondents Using Factor V Molecular Tests by Vendor (Roche, Third Wave, Nanosphere, Other) and End User (Hospitals by Bed Size, Ref Lab)
• Table 9-5: Distribution of Respondents Using Factor V Molecular Tests by Vendor (Roche, Third Wave, Nanosphere, Other) and End User (Hospitals by Bed Size, Ref Lab)
• Table 9-6: Average Number of Factor V Molecular Tests by Vendor (Roche, Third Wave, Nanosphere, Other) and End User (Hospitals by Bed Size, Ref Lab)
• Table 9-7: Number of Respondents Using Factor V Molecular Tests by Reagent Type (Commercial, ASR, Homebrew)
• Table 9-8: Number of Factor II Molecular Tests by Vendor (Roche, Third Wave, Nanosphere, Other) and End User (Hospitals by Bed Size, Ref Lab)
• Table 9-9: Distribution of Factor II Molecular Tests by Vendor (Roche, Third Wave, Nanosphere, Other) and End User (Hospitals by Bed Size, Ref Lab)
• Table 9-10: Number of Respondents Using Factor II Molecular Tests by Vendor (Roche, Third Wave, Nanosphere, Other) and End User (Hospitals by Bed Size, Ref Lab)
• Table 9-11: Distribution of Respondents Using Factor II Molecular Tests by Vendor and End User
• Table 9-12: Average Number of Factor II Molecular Tests by Vendor (Roche, Third Wave, Nanosphere, Other) and End User (Hospitals by Bed Size, Ref Lab)
• Table 9-13: Number of Respondents Using Factor II Molecular Tests by Reagent Type (Commerical Test, ASR, Homebrew)
• Table 9-14: Number of MTHFR Gene Tests by Vendor (Third Wave, Nanosphere, PCR, Other) and End User (Hospitals by Bed Size, Ref Lab)
• Table 9-15: Distribution of MTHFR Gene Tests by Vendor (Third Wave, Nanosphere, PCR, Other) and End User (Hospitals by Bed Size, Ref Lab)
• Table 9-16: Number of Respondents Using MTHFR Gene Tests by Vendor (Third Wave, Nanosphere, PCR, Other) and End User (Hospitals by Bed Size, Ref Lab)
• Table 9-17: Distribution of Respondents Using MTHFR Gene Tests by Vendor (Third Wave, Nanosphere, PCR, Other) and End User (Hospitals by Bed Size, Ref Lab)
• Table 9-18: Average Number of MTHFR Gene Tests by Vendor (Third Wave, Nanosphere, PCR, Other) and End User (Hospitals by Bed Size, Ref Lab)
• Table 9-19: Number of Respondents Using MTHFR Gene Tests by Reagent Type (Commercial, ASR, Homebrew)
• Table 9-20: Number and Percentage of Respondents Performing a Mix of Coagulation Gene Test by Mix (Factor V/Factor II vs Factor V/FactorII/MTHFR) and by End User (Hospital by Bed Size and Reference Labs)

CHAPTER TEN: QUANTITATIVE REVIEW OF THE U.S. MARKET FOR MOLECULAR HERPES SIMPLEX VIRUS (HSV TEST)

• Figure 10-1: Genital Herpes, Initial Visits to Physicians' Offices, National Disease and Therapeutic Index: United States, 1966-2007
• Table 10-1: Selected Molecular HSV Tests Available in the United States
• Table 10-2: Number of HSV Molecular Tests by Vendor (Cepheid, Qiagen, Roche, PCR, Other) and End User (Hospital by Bed Size and Refence Lab)
• Table 10-3: Distribution of HSV Molecular Tests by Vendor (Cepheid, Qiagen, Roche, PCR, Other) and End User (Hospital by Bed Size and Refence Lab)
• Table 10-4: Number of Respondents Using HSV Molecular Tests by Vendor (Cepheid, Qiagen, Roche, PCR, Other) and End User (Hospital by Bed Size and Refence Lab)
• Table 10-5: Distribution of Respondents Using HSV Molecular Tests by Vendor (Cepheid, Qiagen, PCR, Other) and End User (Hospital by Bed Size and Refence Lab)
• Table 10-6: Average Number of HSV Molecular Tests by Vendor (Cepheid, Qiagen, Roche, PCR, Other) and End User (Hospital by Bed Size and Refence Lab)
• Table 10-7: Number of Respondents Using HSV Molecular Tests by Reagent Type (Commercial Test, ASR, Homebrew)

CHAPTER ELEVEN: QUALITATIVE REVIEW OF THE U.S. MARKET FOR MOLECULAR ONCOLOGY TESTS: BCR/ABL, BLADDER CANCER, AND HER2NEU

• Table 11-1: Selected Molecular Oncology Tests Available in the United States
• Table 11-2: Testing Volume of Molecular Oncology Tests by Vendor (Abbott, Roche, PCR, Other) and Analyte (BCR/ABL, Bladder Cancer, Her2Neu)
• Table 11-3: Number of Respondents Using Molecular Oncology Tests by Vendor (Abbott, Roche, PCR, Other) and Analyte (BCR/ABL, Bladder Cancer, Her2Neu)

CHAPTER THIRTEEN: QUALITATIVE REVIEW OF THE U.S. MARKET FOR MOLECULAR TESTS FOR INHERITED DISEASES: CYSTIC FIBROSIS (CF) AND FRAGILE X SYNDROME

• Table 13-1: Selected Diseases that Have a Genetic Component
• Table 13-2: Selected CF Tests Available in the U.S., 2008
• Table 13-3: Number of CF Gene Tests by Vendor (Third Wave, Luminex, Other) and End User (Hospitals by Bed Size and Ref Lab)
• Table 13-4: Distribution of CF Gene Tests by Vendor (Third Wave, Luminex, Other) and End User (Hospitals by Bed Size and Ref Lab)
• Table 13-5: Number of Respondents Using CF Gene Tests by Vendor (Third Wave, Luminex, Other) and End User (Hospitals by Bed Size and Ref Lab)
• Table 13-6: Distribution of Respondents Using CF Gene Tests by Vendor (Third Wave, Luminex, Other) and End User (Hospitals by Bed Size and Ref Lab)
• Table 13-7: Number of Tests and and Respondents Using Fragile X Tests by End User (Hospital by Bed Size and Refererence Lab)
• Table 13-8: Number of Tests and Number of Respondents Using Fragile X Tests by Type of Reagents (PCR vs Other)

CHAPTER FOURTEEN: QUALITATIVE REVIEW OF THE U.S. MARKET FOR MOLECULAR TESTS FOR RESPIRATORY INFECTIONS: INFLUENZA A/B, GROUP A STREP, MTB (TUBERCULOSIS), BORDETELLA PERTUSSIS, ADENOVIRUS, AND RESPIRATORY VIRUS

• Table 14-1: Selected FDA-Cleared Molecular Respiratory Infection Tests
• Table 14-2: Number of Molecular Respiratory Infection Tests by Organism (Strep A, Bordetella, Influenza A/B, TB, Adenovirus, Respiratory Virus) and by Vendor (BD/GeneOhm, bioMerieux, Cepheid, Gen-Probe, Luminex, Prodesse, Qiagen, Roche, PCR, Other)
• Table 14-3: Distribution of Molecular Respiratory Infection Tests by Organism (Strep A, Bordetella, Influenza A/B, TB, Adenovirus, Respiratory Virus) and by Vendor (BD/GeneOhm, bioMerieux, Cepheid, Gen-Probe, Luminex, Prodesse, Qiagen, Roche, PCR, Other)
• Table 14-4: Number of Respondents Using Molecular Respiratory Infection Tests by Organism (Strep A, Bordetella, Influenza A/B, TB, Adenovirus, Respiratory Virus) and by Vendor (BD/GeneOhm, bioMerieux, Cepheid, Gen-Probe, Luminex, Prodesse, Qiagen, Roche, PCR, Other)
• Table 14-5: Distribution of Respondents Using Molecular Respiratory Infection Tests by Organism (Strep A, Bordetella, Influenza A/B, TB, Adenovirus, Respiratory Virus) and by Vendor (BD/GeneOhm, bioMerieux, Cepheid, Gen-Probe, Luminex, Prodesse, Qiagen, Roche, PCR, Other)
• Table 14-6: Average Number of Molecular Respiratory Infection Tests by Organism (Strep A, Bordetella, Influenza A/B, TB, Adenovirus, Respiratory Virus) and by Vendor (BD/GeneOhm, bioMerieux, Cepheid, Gen-Probe, Luminex, Prodesse, Qiagen, Roche, PCR, Other)
• Table 14-7: Market Growth Data: Estimated Test Volume Increase by Organism (Strep A, Bordetella, Influenza A/B, TB, Adenovirus, Respiratory Virus)

CHAPTER FIFTEEN: QUALITATIVE REVIEW OF THE U.S. MARKET FOR MOLECULAR TESTS FOR COMMUNICABLE DISEASES: CMV (CYTOMEGALOVIRUS), EBV (EPSTEIN-BARR VIRUS), GROUP B STREP, AND ENTEROVIRUS

• Table 15-1: Number of Molecular Communicable Disease Tests by Organism (CMV, EBV, Strep B, Enterovirus) and Vendor (Abbott, BD/GeneOhm, Cepheid, Gen-Probe, Qiagen, Roche, PCR, Other)
• Table 15-2: Distribution of Molecular Communicable Disease Tests by Organism (CMV, EBV, Strep B, Enterovirus) and Vendor (Abbott, BD/GeneOhm, Cepheid, Gen-Probe, Qiagen, Roche, PCR, Other)
• Table 15-3: Number of Respondents Using Molecular Communicable Disease Tests by Organism (CMV, EBV, Strep B, Enterovirus) and Vendor (Abbott, BD/GeneOhm, Cepheid, Gen-Probe, Qiagen, Roche, PCR, Other)
• Table 15-4: Distribution of Respondents Using Molecular Communicable Disease Tests by Organism (CMV, EBV, Strep B, Enterovirus) and Vendor (Abbott, BD/GeneOhm, Cepheid, Gen-Probe, Qiagen, Roche, PCR, Other)
• Table 15-5: Average Number of Molecular Communicable Disease Tests by Organism (CMV, EBV, Strep B, Enterovirus) and Vendor (Abbott, BD/GeneOhm, Cepheid, Gen-Probe, Qiagen, Roche, PCR, Other)
• Table 15-6: Market Growth Data: Estimated Test Volume Increase by Organism (CMV, EBV, Strep B, Enterovirus)