Updated CDC HIV Testing Guidelines to Shape Evolving Diagnostics Market

This publication has been discontinued on December 21, 2011.

Introduction

Abstract

Introduction

HIV/AIDS stands out as a highly lucrative and expanding market for diagnostics companies because of the close integration of diagnostics in initial diagnosis and subsequent day-to-day disease management. With the newly released CDC screening recommendations advocating increased testing for the infection, diagnostics will play an increasingly critical role in HIV disease management.

Get the Answers You Need to Shape Your Strategy

• The revised CDC guidelines for HIV testing are set to dramatically benefi t the HIV diagnostics market in the
• United States. Which sectors of the diagnostics market will benefi t most? What will be the long-term
• impact of the CDC recommendations?
• The new recommendations have changed HIV testing from an “opt-in” diagnostic to an “opt-out” test that is
• a routine part of medical practice. How will this new process affect the diagnosis rates for HIV? Will it
• dramatically increase treatment rates?
• HIV diagnosis is currently a multistep process that involves time-consuming confi rmatory tests. In its new
• recommendations, the CDC advocates the use of rapid testing. How will the CDC recommendations impact
• the rapid testing arena? Which companies are the key players in this sector?
• With the increase in drug resistance among HIV/AIDS patients, resistance testing is playing a growing role in
• HIV disease management. Will the new CDC recommendations increase use of monitoring tests as well?
• What unmet needs remain in the resistance testing sector? Which companies are active in this area?

Scope

• Discussion of new CDC recommendations: revisions, rationale, target populations, and response to changes.
• Current HIV diagnostics: screening, confi rmatory, and monitoring tests.
• Emerging HIV diagnostics: home test kits, replication capacity tests, and CCR5 and CXCR4 tests.
• Key players: profi les of select leaders in HIV diagnostics.
• Outlook for HIV diagnostics: impact of CDC guidelines on diagnostics and on drug treatment,
• constraints on routine testing, and strategic considerations.

Companies:

• Abbott Laboratories
• Beckman Coulter
• Becton Dickinson
• BioMerieux
• Bio-Rad Laboratories
• Bristol-Myers Squibb
• Calypte Biomedical
• Celera Diagnostics
• Chembio Diagnostic Systems
• Gen-Probe
• Gilead Sciences
• GlaxoSmithKline
• Guava Technologies
• Home Access Health
• LabCorp
• MedMira Laboratories
• Monogram Biosciences
• Murex Diagnostics
• OraSure Technologies
• Partec
• pfizer
• Roche Molecular Diagnostics
• Siemens Medical Solutions
• Diagnostics
• Specialty Laboratories
• Trinity Biotech
• Virco
• ViroLogic
• Visible Genetics
• Waldheim Pharmazeutika

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

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