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Table 4.6: Largest Market Opportunities in PCR Testing 200
Table 4.7: PCR Real-Time Applications 205
Table 4.8: Advantages of Using Real-Time PCR 205
Table 4.9: Pharmaceutical Company Challenges 205
Table 4.10: Molecular Diagnostic Sector Acquisitions, Agreements and
Partnerships 207
Table 4.11: Regulatory Rules that Affect the Ability of a Diagnostic Testing
Reagent Company to Conduct Business 211
Table 4.12: Strengths of the 510k Process 216
Table 4.13.: Focus Areas for the FDA Critical Path Initiative 221
Table 4.14: Medicare Pricing Methods 225
Table 4.15: Factors Affecting Third-Party Reimbursement for Molecular Diagnostic
Tests 226
Table 4.16: Documents for Protecting Intellectual Property Rights 228
Table 4.17: Recent Patents Related to PCR, Nucleic Acid Amplification, and
Sample Prep 229
Table 5.1: Molecular Diagnostic High-throughput Automated Testing Systems 232
Table 6.1: Five Molecular Diagnostics Growth Areas 245
Table 6.2: Limitations of Nucleic Acid Chip Probes 245
Table 6.3: Companies Licensed to Sell Custom Molecular Beacon Probes 250
Table 6.4: U.S. Sample Preparation Market, 2005-2012 253
Table 7.1: Products Marketed by Abbott in the Diagnostics Market 259
Table 7.2: Gen-Probe Key Acquisitions 290
Table 7.3: Roche Diagnostics Key Products 305
Table 7.4: Sales by Region 305
Table 7.5: Sales by Business Area 305
Table 7.6: Product Line Sales 306
Table 7.7: Growth Drivers 306
Table 8.1: Number of Molecular Diagnostics Tests in the U.S., 2008-2015 312
Table 8.2: Global Molecular Diagnostics Testing Revenues, 2000-2016 316
Table 8.3: Global Distribution of Molecular Diagnostics Testing by Geographic
Region, 2010 317
Table 8.4: U.S. Molecular Diagnostics Testing Market, 2004-2016 319
Table 8.5: European Mo
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