Cytology and HPV Testing World Markets

Cytology and HPV Testing World Markets

Cancer is a group of diseases characterized by uncontrolled growth and spread of abnormal cells. If the spread is not controlled, it can result in death. Cancer is caused by both external (chemicals, radiation and viruses) and internal (hormones, immune conditions and inherited mutations) factors. Causal factors may act together or in sequence to initiate or promote carcinogenesis. Ten or more years often pass between exposures or mutations and detectable cancer. Cancer is treated by surgery, radiation, chemotherapy, hormones and immunotherapy. The purpose of this TriMark Publications report is to describe the specific segment of the diagnostic market aimed at analysis cytology (the examination of cells using optical microscopy methods) specimens derived from the human female reproductive tract. It examines the measurement devices and their reagents and supplies used in hospitals, clinics, commercial laboratories and research institutions to detect cells and proteins for the diagnosis and monitoring of disease. The study describes the analytical methods used to separate, isolate, characterize and quantitate cells, DNA and proteins complex in biological systems related to the diagnosis and treatment of disease of the female reproductive tract, such as the cervix and vagina. The emphasis is on those companies and products that are actively developing and marketing laboratory instrumentation, reagents and supplies for performing cytology and related molecular diagnostic tests, such as human papillomavirus (HPV) and other inflammatory and sexually-transmitted diseases.

2.1.1The Disease

2.1.2 Metastasis

2.1.3 Demographics and Statistics of Cancer

2.2.1 Technological Innovation

2.2.2 Government Funding

2.2.3 Pharmaceutical Development

3.3.1 Screening for Cervical Cancer

3.3.2 Screening Procedures and Pap Smear Technology

4.1.1 Human Papillomavirus

4.1.2 North American Market

4.1.3 European Market

4.1.4 Latin American Market

5.1.1 TriPath Imaging

5.1.2 Cytyc

5.1.3 Molecular Diagnostics, Inc.

5.2.1. Cervical Cytology Product Line

5.2.1.1 The SurePath Test Pack

5.2.1.2 PrepStain Slide Processor

5.2.1.3 FocalPoint Imaging System

5.2.1.4 SlideWizard Product Line

5.2.1.5 Molecular Diagnostics Products

5.2.1.6 Molecular Imaging Systems

5.2.1.7 Blood-based Reagents

5.2.2 Cytyc’s Products

5.2.2.1 The ThinPrep System

5.2.2.1.1 Additional Applications of the ThinPrep System

5.2.2.2 The ThinPrep Process

5.2.2.3 Clinical Studies Evaluating the ThinPrep Pap Test

5.2.2.4 Competition

5.2.2.5 Surgical Products

5.2.2.6 The NovaSure System

5.2.2.7 Competition

5.2.3 Molecular Diagnostics’ Products and Services

5.2.3.1 InPath System Key

5.3.1 TriPath Imaging Sales and Marketing

5.3.1.1 Total Sales and Marketing

5.3.1.2 Commercial Operations

5.3.1.3 TriPath Oncology Sales and Marketing

5.3.1.4 Marketing Strategy

5.3.1.5 TriPath’s Molecular Diagnostic Products

5.3.2 Cytyc Marketing and Sales

5.3.2.1 Sales and Marketing Costs

5.3.2.2 Cytyc’s Marketing and Sales Strategy

5.3.2.2.1 Domestic Strategy

5.3.2.2.2 International Strategy

5.3.2.3 Sales Strategy - Cervical Cytology Product Line

5.3.2.3.1 Molecular Diagnostics

5.3.2.3.2 Marketing and Sales Organizations

5.3.2.3.3 Outside the U.S. with the Exception of Canada

5.4.1 Manufacturing Standards for Diagnostic Products

5.5.1 Molecular Diagnostic Reagents

6.1.1 Digene

6.1.1.1 Digene Products

6.1.2 Ventana Medical Systems

6.2.1 HPV Tests

6.2.2 Chlamydia and Gonorrhea Tests

6.2.3 Blood Virus Tests

6.2.4 Instrumentation and Accessory Products

6.3.1 International Markets

6.3.2 Europe

6.3.3 Central and South America

6.3.4 Asia/Pacific

6.3.5 Strategy

6.5.1 Ventana

6.6.1 Ventana Products

7.11.1 North American Market

8.2.1 Clinical Laboratory Improvement Act of 1988 and State Laboratory Laws

8.2.2 Foreign Regulatory Approval

10.6.1 Reporting Screening and Diagnostic Pap Smears

10.6.2 HCPCS (HCFA Common Procedure Coding System) Code Definitions

10.6.3 CPT (Current Procedural Terminology) Code Definitions

11.1.1 Cytyc Barriers

11.1.2 Digene Risk Factors

11.1.3 Ventana

11.1.3.1 Ventana factors that could affect future results

13.2.1 Development of Molecular Diagnostic Products

13.4.1 Instrumentation Development Projects

13.4.2 Reagent Development Projects

14.2.1 Hybrid Capture Technology

14.2.2 Rights to HPV Types

14.2.3 Other Intellectual Property

14.2.3.1 Trademark

15.1.1 Contact

15.1.2 About the Cytyc Corporation

15.2.1 Diagnostic Products

15.2.2 The ThinPrep Process

15.3.1 Top Executives and Salaries

15.3.2 Board of Directors

17.1.1 Industry Key Players

17.1.1.1 Cytology Screening Testing Market Structure

17.1.1.2 Human papillomavirus (HPV) Testing Market Structure

17.4.1 Microscopic Slide Based Reagents

17.4.2 Molecular Imaging Systems

17.4.3 Blood-Based Reagents

17.6.1 Digene’s HPV Tests

17.6.2 Digene’s Chlamydia and Gonorrhea Tests

17.6.3 Digene’s Blood Virus Tests

17.6.4 Digene’s Instrumentation and Accessory Products

18.3.1 Financial Analysis

19.1.1 Industry Definition

19.1.1.1 Cytology Products

19.1.2 Industry Key Players

19.1.3 Company’s Outlook on the Industry

19.4.1 Digene’s Competitive Advantage

19.4.2 Molecular Diagnostic Reagents

19.4.3 TriPath Imaging, Inc.

19.5.1 Cervical Cytology Product Line (Formerly the i3 Series Product Line)

19.5.1.1 PrepStain Slide Processor

19.5.1.2 FocalPoint Imaging System

19.5.1.3 SlideWizard Product Line

19.5.2 Molecular Diagnostics Products

19.5.2.1 Microscopic Slide Based Reagents

19.5.2.2 Molecular Imaging Systems

19.5.2.3 Blood-Based Reagents

19.6.1 Top Executives and Salaries

20.1.2 TriPath Oncology Revenues

21.1.1 Industry Definition

21.1.1.1 Cytology Products

21.1.1.2 Molecular Diagnostic Products

21.1.2 Industry Key Players

21.4.1 Blood-Based Reagents

21.5.1 Competition

21.5.1.2 TriPath’s Competitive Advantage

21.5.1.3 Molecular Diagnostic Reagents

21.5.1.4 Ventana