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-Jakobs 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

List of Tables
Molecular Diagnostics Test Volume and Sales Forecasts by Major Application
Molecular Diagnostics Test Volume by Major Application
Major Infectious Disease Test Volume by Assay
Major Infectious Disease Test Volume by Method
Molecular Diagnostics Market by Major Application
Major Infectious Disease Diagnostics Market by Assay
Major Companies Developing or Marketing Salmonella Molecular Diagnostic Tests
Major Companies Developing or Marketing AIDS Molecular Diagnostic Tests
Major Companies Developing or Marketing Adenovirus Molecular Diagnostic Tests
Major Companies Developing or Marketing Bartonella Molecular Diagnostic Tests
Major Companies Developing or Marketing Campylobacter Molecular Diagnostic Tests
Major Companies Developing or Marketing Candida Molecular Diagnostic Tests
Major Companies Developing or Marketing Chlamydia Molecular Diagnostic Tests
Major Companies Developing or Marketing Clostridium Molecular Diagnostic Tests
Major Companies Developing or Marketing Coronavirus Molecular Diagnostic Tests
Major Companies Developing or Marketing Cryptosporidium Molecular Diagnostic Tests
Major Companies Developing or Marketing CMV Molecular Diagnostic Tests
Major Companies Developing or Marketing Echovirus Molecular Diagnostic tests
Major Companies Developing or Marketing Enterovirus Molecular Diagnostic tests
Major Companies Developing or Marketing EBV Molecular Diagnostic Tests
Major Companies Developing or Marketing Giardia Molecular Diagnostic Tests
Major Companies Developing or Marketing Gonorrhea Molecular Diagnostic Tests
Major Companies Developing or Marketing Hantavirus Molecular Diagnostic Tests
Major Companies Developing or Marketing Helicobacter Molecular Diagnostic Tests
Major Companies Developing or Marketing Hepatitis Molecular Diagnostic Tests
Major Companies Developing or Marketing Herpes Molecular Diagnostic Tests
Major Companies Developing or Marketing Influenza Molecular Diagnostic Tests
Major Companies Developing or Marketing Legionella Molecular Diagnostic Tests
Major Companies Developing or Marketing Lyme Disease Molecular Diagnostic Tests
Major Companies Developing or Marketing Measles Molecular Diagnostic Tests
Major Companies Developing or Marketing Meningitis Molecular Diagnostic Tests
Major Companies Developing or Marketing Mononucleosis Molecular Diagnostic Tests
Major Companies Developing or Marketing Mumps Molecular Diagnostic Tests
Major Companies Developing or Marketing Mycoplasma Molecular Diagnostic Tests
Major Companies Developing or Marketing Pneumonia Molecular Diagnostic Tests
Major Companies Developing or Marketing RSV Molecular Diagnostic Tests
Major Companies Developing or Marketing Rotavirus Molecular Diagnostic Tests
Major Companies Developing or Marketing Rubella Molecular Diagnostic Tests
Major Companies Developing or Marketing Septicemia Molecular Diagnostic Tests
Major Companies Developing or Marketing Shigella Molecular Diagnostic Tests
Major Companies Developing or Marketing Streptococci Molecular Diagnostic Tests
Major Companies Developing or Marketing Syphilis Molecular Diagnostic Tests
Major Companies Developing or Marketing Toxoplasmosis Molecular Diagnostic Tests
Major Companies Developing or Marketing Trichomonas Molecular Diagnostic Tests
Major Companies Developing or Marketing Tuberculosis Molecular Diagnostic Tests
Oncogenes Potential Application in Cancer Diagnosis
Major Companies Developing or Marketing Cancer Molecular Diagnostic Tests
Major Companies Developing or Marketing Molecular Diagnostic Tests For Genetic Diseases