Who's Doing What in Molecular Diagnostics? - Kalorama / Emmes Survey of US Laboratories

From Kalorama Information a unique tool for assessing the diagnostic business today. Working in conjunction with premier diagnostic survey database Emmes Group, Kalorama Information presents the summarized results from a recent survey of a critical mass of diagnostic labs in the U.S, with analysis from Kalorama's leading diagnostic analyst, Shara Rosen. Far more than any other market research report, this report provides the most...

More »

From Kalorama Information a unique tool for assessing the diagnostic business today. Working in conjunction with premier diagnostic survey database Emmes Group, Kalorama Information presents the summarized results from a recent survey of a critical mass of diagnostic labs in the U.S, with analysis from
Kalorama's leading diagnostic analyst, Shara Rosen.


Far more than any other market research report, this report provides the most current and accurate picture of what is truly going on in molecular diagnostics in the United States.


Quantitative Data



Analyzed by the best-selling author of The Worldwide Market for In Vitro Diagnostics, now in its sixth edition, this new report includes surveys of molecular diagnostics focusing on these tests:

• Chlamydia and Gonorrhea


• HBV Viral Load


• HCV Viral Load, HCV Genotyping


• HIV Viral Load, HIV Genotyping


• HPV, HPV Genotyping


• Hospital Acquired Infections - MRSA, VRE


• Coagulation Factors - Factor II, Factor V Leiden


• Herpes Simplex Virus (HSV)


• Oncology Tests - BCR/ABL, Bladder Cancer, Her2Neu, MTHFR


• Transplant Medicine - HLA Typing


• Hereditary Disorders - Cystic Fibrosis (CF), Fragile X


• Respiratory Infections - Influenza A/B, Group A Strep, MTB (Tuberculosis), Bordetella pertussis, Adenovirus, Respiratory Virus


• Communicable Diseases - CMV (Cytomegalovirus), EBV (Epstein-Barr Virus), Group B Strep, Enterovirus

What Labs Do Now, What They are Planning in the Future


There has been much analysis in recent years about the inroads that DNA testing has made. This unique resource offers a way to measure that progress, and test assumptions aobut the evolution of DNA testing, critical information to adjust business stratetgies. This report looks at the following topics:

• What type of reagents are labs using (Commercial, ASR, Homebrew)


• Where tests are performed (Central/Core Testing Lab, Chemistry Lab, Cytology Lab, Genetics Lab, Hematology Lab, Microbiology Lab, Molecular Lab, Pathology Lab, Serology/Immunology Lab, Virology Lab)


• What Vendors are Labs Using


• What are there Purchasing Plans


• What Tests Do They Want in the Future


• Do They Outsource and at what Rate?


• Do They plan Vendor Changes?

A Representative Sample of the US Hospital Lab Industry


Emmes Group reached an extensive sample group - interviewing 14% of US hospital labs, 14% of public labs and 8% of US reference lab, where Emmes respondent numbers are compared to the Americian Hospital Directory. Such an undertaking would cost an individual company tens of thousands of dollars. This information is available to purchasers of this report at a fraction of the cost.

Healthcare Industry in the United States

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)