Updated CDC HIV Testing Guidelines to Shape Evolving Diagnostics Market

Table of Contents

• Executive Summary
  • Strategic Considerations
  • Stakeholder Implications
• Introduction
  • Revised Guidelines and Target Populations
  • HIV Testing and Prevention Trends
• Background on HIV Guidelines and Impact of New Guidelines
  • Factors Infl uencing the CDC Recommendations for Routine Screening
  • Screening for HIV in the Health Care Setting
  • Advantages of Rapid Screening Tests
  • Monitoring of HIV-Infected Adults and Adolescents
    • Baseline Measurement
    • Timing of Treatment Initiation
    • Timing of Therapy Switch
  • Response of Various Professional Groups
• Regulation of HIV Diagnostics
• Impact of Routine HIV Testing on Patient Groups
  • People Unaware of Their HIV Serostatus
  • People Diagnosed at an Advanced Stage of Disease
  • Pregnant Women
• Current Diagnostics
  • Screening Tests
  • Confi rmatory Tests
  • Monitoring Tests
    • CD4 T-Cell Count
    • Viral Load Test
    • Resistance Tests
• Emerging Diagnostics
  • Over-the-Counter HIV Home Test Kits
  • Viral Fitness (Replication Capacity) Tests
  • CCR5 and CXCR4 Tropism Tests
• Select Key Players in HIV Diagnostics
  • OraSure Technologies
  • BioMerieux
• Outlook
  • Impact of CDC Guidelines on Routine HIV Screening
    • Impact on Diagnostics Sectors
    • Impact on Drug Treatment
  • Constraints on Routine HIV Testing
  • Strategic Considerations
    • Development of Improved and New Products
    • Infl uencing Decision Makers
    • Synergy with Drugs
• Appendix A. Bibliography
• Appendix B. Explanation of Terms Used in This Report

Tables

• 1. High-Risk Categories for HIV Infection
• 2. Synopsis of the CDC HIV Testing Guidelines for Adults, Adolescents, and Pregnant Women in Health Care Settings
• 3. Summary of Recommendations for Administration of HIV Diagnostics in the Major Pharmaceutical Markets
• 4. Select FDA-Approved HIV Screening and Confi rmatory Tests
• 5. Select HIV Monitoring Tests
• 6. Select HIV Resistance Tests Available in the Major Markets

Figures

• 1. Segmentation of Newly Diagnosed HIV Cases by Transmission Category in the Major Markets
• 2. Proportion of People Aged 18-64 in the United States Who Reported Being Tested for HIV
• 3. Timeline of Key Advances in HIV Diagnostics and Testing Guidelines in the United States
• 4. Interplay of HIV Diagnostics in the Treatment Cycle
• 5. HIV: Diagnosed and Undiagnosed Population Proportions, 2005
• 6. Estimated Sexual Transmission of HIV in People Aware and Unaware of Their Serostatus in the United States