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

V. Potential Market Entry Barriers and Risks

VI. Molecular Diagnostic Technology Review

A. DNA Sequencing
B. DNA and RNA Probe Technologies
C. Detection Technologies
D. Biochips: Genosensors, Microarrays, and Labs-on-the-Chip
E. Pharmacogenomics
F. Competing/complementing
1. Monoclonal Antibodies/Immunoassays
2. RNA Probes
3. Two-Dimensional Electrophoresis
4. Flow Cytometry

VII. Molecular Diagnostic Instrumentation Review

VIII. 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
- Yersinia
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
- Multilocus Probes
- Single Locus Probes
- PCR and RFLP
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

IX. Market Size and Growth: Test Volume and Sales Forecasts

X. Competitive Assessments

- Abbott
- 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
- Thermo Fisher/Affymetrix

XI. Appendix: Research Centers Developing New Technologies and Products