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4.6.6.5 Medicare Reimbursement Threats 225
4.7 Patent Protection and Intellectual Property Rights 227
4.7.1 New Patents 228
4.7.2 BRCA1 and BRCA2 Gene Patents 229
4.7.3 Current Patent Disputes 230
4.8 Micoarray Quality Control (MAQC) 230
5. Molecular Diagnostics Automated Instrumentation Approved for Market by the
FDA 232
5.1 Gene Expression Profiling 233
5.2 Proteomic Multiplex Assays 234
5.3 Solution-Phase Multiplexing 234
5.4 RNA Interference (RNAi) 234
5.4.1 Role of RNAi in Drug Target Validation 235
5.4.2 Other Companies involved in the RNAi Market 235
5.5 DNA Tags 236
5.6 Follow-on Optical Technologies 237
6. Market Trends and Forecasts 238
6.1 Market Dynamics 238
6.1.1 Molecular Diagnostics Market Opportunities 238
6.1.2 Market Forces 240
6.2 Future Considerations for Molecular Diagnosis 241
6.3 Role of Genomics in Transforming Pharmaceutical R&D 242
6.4 Cancer Markers 242
6.5 Cytology Markers 243
6.6 RNA Detection 243
6.7 Diagnosis of Inherited Disease 243
6.8 Ethical Considerations 243
6.9 NAT and Personalized Medicine 244
6.10 Five Molecular Diagnostics Growth Areas 245
6.11 Specific Commercial Nucleic Acid Probes 245
6.12 Novel Amplification Techniques in the Market 246
6.13 Ramification Amplification Method (RAM) 247
6.14 Invader Assays/Third Wave Technologies (Hologic) 248
6.15 Molecular Beacons 249
6.16 Human Leukocyte Antigen (HLA) Sequencing-based Typing Kits 251
6.17 Prenatal Diagnosis 251
6.18 Newborn Screening 251
6.19 NAT and Preventive Medicine: NAT-based Assays 252
6.20 Prenatal and Pre-Implantation Diagnosis 252
6.21 FISH-based Tests on Fetal Cells 252
6.22 Companion Therapeutic/Diagnostic Approach 252
6.23 Sample Preparation Market 253
6.24 Eme
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