I. Introduction

II. Major Product Development Opportunities

A. Instrumentation
B. Reagent Kits and Test Systems/panels
C. Computers, Software and Automation
D. Auxiliary Products

III. Design Criteria for Decentralized Testing Products

IV. Alternative Market Penetration Strategies

A. Internal Development
B. Collaborative Arrangements
C. University Contracts
D. Distribution Strategies for Decentralized Testing Markets

V. Potential Market Entry Barriers and Risks

A. Market Maturity
B. Cost Containment
C. Competition
D. Technological Edge and Limitations
E. Patent Protection
F. Regulatory Constraints
G. Decentralized Testing Market Challenges

VI. Market and Technology Review

A. DNA Sequencing
1. Introduction
2. Sequencing Methods
3. Autoradiography
4. The Human Genome Project
5. Sequencing Automation
6. Image Scanners
7. Fluorescent Detection
8. Gene Profiling
9. Gene Expression
10. Polymorphism Screening
11. Protein Interaction Networks
B. DNA and RNA Probe Technologies
1. Basic Principles
2. Probe Preparation
3. The DNA Probe Test
4. Test Formats
5. Labeling Techniques
6. Amplification Methods
C. Detection Technologies
1. Radioactive Methods
a. Overview
b. Major Isotopes
2. Non-Isotopic Methods
a. Enzymatic Labels
b. Chemical Labeling
c. Fluorescence
d. Chemiluminescence
e. Electrical Conductivity
D. Molecular Diagnostic Instrumentation Review
1. Abbott LCx
2. Beckman Coulter/Biomek FK
3. BD Viper System with XTR Technology
4. BD Innova
5. Becton Dickinson SDA
6. bioMerieux NucliSENS easyMAG
7. bioMerieux NucliSENS easyQ and MiniMAG
8. Bio-Rad GeneScope
9. Cepheid GeneXpert
10. Curetis Unyvero
11. GenMark Dx eSensor XT-8
12. Hologic/Gen-Probe Panther
13. Hologic/Gen-Probe Tigris/DTS
14. HTG Molecular Edge
15. Life Technologies QuantStudio Dx
16. Qiagen QIAsymphony RGQ
17. Roche Cobas Amplicor
18. Roche Cobas TaqMan 48
19. Roche Cobas TaqMan
20. Roche Cobas TaqMan AmpliPrep
21. Roche LighCycler 480
22. Roche Cobas 4800
23. Roche Cobas s 201
24. Siemens Versant
25. Tecan LS Series
E. Biochips: Genosensors, Microarrays, Labs-on-the-Chip
- Liquid Transportation and Mixing
- Separation
- Reaction
- Detection
F. Pharmacogenomics
G. Major Applications
1. Microbiology/Infectious Diseases
a. Overview
b. Major Infectious Diseases
- AIDS/HIV
- Adenovirus
- Aeromonads
- Anthrax/Bacillus Anthracis
- Arboviruses
- Babesiosis
- Bacillary Epithelioid Angiomatosis (BEA), other Bartonella (Rochalimaea)
- Blastocystis Hominis
- Brucella
- Campylobacter
- Candida
- Chagas Disease
- Chancroid
- Chlamydia
- Clostridium Difficile
- Coronaviruses
- Coxsackieviruses
- Creutzfeldt-Jakob's Disease
- Cryptosporidium Parvum
- Cyclospora Cayetanensis
- Cytomegalovirus
- Ebola Virus
- E. Coli
- EchoVirus
- Encephalitis
- Enteroviruses
- Epstein-Barr Virus
- Giardia Lamblia
- Gonorrhea
- Granuloma Inguinale
- Hantavirus
- Helicobacter Pylori
- Hepatitis
- Herpes Simplex Virus
- Human Herpes Virus-6 (HHV-6)
- Influenza Viruses
- Legionella
- Lyme Disease
- Lymphogranuloma Venereum (LGV)
- Malaria
- Measles (Rubeola)
- Meningitis
- Microsporidium
- Mononucleosis
- Mumps
- Mycoplasma
- Papillomaviruses
- Parvovirus B19
- Pneumonia
- Polyomaviruses
- Pseudomonas Aeruginosa
- Rabies
- Respiratory Syncytial Virus (RSV)
- Rhinoviruses
- Rotavirus
- Rubella
- Salmonellosis
- Septicemia
- Shigellosis
- Staphylococcus Aureus
- Streptococci
- Syphilis
- Toxoplasmosis
- Trichomonas Vaginalis
- Tuberculosis
- Vibrio
- West Nile Virus
- Yersina
2. Cancer Testing
a. Overview
b. Major Cancer Types
- Prostate
- Lung
- Colon and Rectum
- Breast
- Skin
- Uterine
- Leukemia
- Oral
c. Oncogenes
- Abl/abl-bcr
- AIB1
- BCL-2
- BRCA1
- CD44
- C-fos
- C-myb
- C-myc
- CYP17
- Erb-B
- HPC1
- N-myc
- P40
- P51
- P53
- PIK3CA
- PTI-1
- Ras
- Reg
- Sis
- Src
3. Genetic Diseases
a. Overview
b. Nucleic Acid Amplification
c. Chromosome Imaging
d. Genomics Technologies
e. Proteomics Technologies
f. Current Pharmacogenomic Tests
g. Future Pharmacogenomic Testing
h. Major Diseases
- Achondroplasia
- Autosomal Dominant Polycystic Kidney Disease
- Cancer
- Cosmetogenomics
- Cystic Fibrosis
- Down's Syndrome
- Duchenne and Becker Muscular Dystrophy
- Factor V (Leiden)
- Factor IX Deficiency
- Fragile X Syndrome
- Heart Disease
- Hemochomatosis
- Hemophilia
- Huntington's Disease
- Maternal-Fetal Incompatibility
- Multiple Endocrine Neoplasia
- Phenylketonuria (PKU)
- Polycystic Kidney Disease (PKD)
- Prenatal Screening
- Retinitis Pigmentosa
- Retinoblastoma
- Sickle Cell Anemia
- Spinal Muscular Atrophy
- Vitamin B12 Metabolism
i. Social Issues and Concerns
4. Forensic Testing
a. Overview
b. Multilocus and Single Locus Probes
c. DNA Profile Data Banks
d. Judicial Implementation
e. Major Crime Categories
f. Factors Contributing to the DNA Probe Market Expansion
- Technology Availability
- Use of Hair as Evidence
g. Wildlife Forensics
5. Paternity Testing/HLA Typing
6. Other Applications
a. Disease Susceptibility Testing
b. Cardiovascular Diseases
c. Diabetes
d. Alzheimer's Disease
e. Periodontal Disease
f. Plasma Purification
g. Organ Transplantation
h. Water Contamination
i. Other
H. Competing/complementing
1. Monoclonal Antibodies/Immunoassays
2. RNA Probes
3. Two-Dimensional Electrophoresis
4. Flow Cytometry

VII. Country Analyses: Volume and Sales Forecasts--Infectious Diseases, Genetic Diseases, Cancer,

Forensic and Paternity Testing
- Austria
- Belgium
- Bulgaria
- Croatia
- Cyprus
- Czech Republic
- Denmark
- Estonia
- Finland
- France
- Germany
- Greece
- Hungary
- Iceland
- Ireland
- Italy
- Latvia
- Lithuania
- Malaysia
- Netherlands
- Norway
- Poland
- Portugal
- Romania
- Serbia
- Slovakia
- Slovenia
- Spain
- Sweden
- Switzerland
- UK

VIII. Competitive Assessments

- Abbott
- Affymetrix/Thermo Fisher
- Agilent Technologies
- Applied Gene Technologies
- Arca Biopharma
- Beckman Coulter/Danaher
- Becton Dickinson
- Biokit
- bioMerieux
- Bio-Rad
- Biotest
- CellMark Forensics/LabCorp
- Cepheid
- Decode Genetics
- Diadexus
- Eiken
- Elitech Group
- Enzo
- Exact Sciences
- Fujirebio
- Grifols
- Hologic/Gen-Probe
- Illumina
- Kreatech/Leica
- Li-Cor Biosciences
- Monogram Biosciences/LabCorp
- Myriad Genetics
- Ortho-Clinical Diagnostics
- Perkin Elmer/Caliper
- Proteome Sciences
- Qiagen
- Roche
- Scienion
- Sequenom
- Shimadzu
- Siemens
- Sierra Molecular
- Takara Bio
- Tecan Group

IX. Appendix: Major Universities and Research Centers Developing Innovative

Molecular Diagnostic Technologies and Products