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Reportlinker Adds Molecular Diagnostics Markets
Date:3/31/2011

ing 197

4.3.8 Neonatal Screening 197

4.4 Drivers and Restraints 198

4.5 Market Forecast 200

4.6 Business Trends in the Industry 200

4.6.1 Molecular Diagnostics Industry Trends 200

4.6.1.1 Adoption of Amplified Screening Technology 201

4.6.1.2 Advances in Automated Testing 201

4.6.1.3 Responsiveness to Newly Emerging Threats 201

4.6.1.4 Increased Focus on Safety of Blood Supply 201

4.6.1.5 Growth in Viral Load Testing 202

4.6.1.6 Development of Emerging Markets for NAT Technology 202

4.6.1.7 Improvements in Detection Technologies 203

4.6.1.8 Use of Multiplex PCR Tests 203

4.6.2 Pharmaceutical Industry Trends 205

4.6.3 Acquisitions, License Agreements and Partnerships 207

4.6.4 Ethical, Legal and Social Issues Related to the Use of Genetic Information

211

4.6.5 Regulatory Issues 211

4.6.5.1 U.S. Food and Drug Administration 212

4.6.5.2 CLIA Regulations 212

4.6.5.3 Clinical Laboratory Improvement Act (CLIA) 213

4.6.5.4 State Licensing for Service Laboratories 215

4.6.5.5 Multivariate Index Assays (IVDMIAs) 215

4.6.5.6 510(k) Clearance 216

4.6.5.6.1 Pre-Market Approval (PMA) 216

4.6.5.7 PMAs 217

4.6.5.8 ASRs 218

4.6.5.9 Laboratory Developed Tests 218

4.6.5.10 What Regulatory Guidance is needed for Companion Biomarkers? 219

4.6.5.11 U.S. Patent and Trademark Office (USPTO) 221

4.6.5.12 IRB Approval in Clinical Trials 221

4.6.5.13 CE marking and the IVDD (European In Vitro Diagnostic Device Directive)

221

4.6.5.14 De Novo Classification 221

4.6.5.15 Research Use Only Reagents 222

4.6.6 Reimbursement Issues and Billing Landscape for Molecular Diagnostics

Testing 222

4.6.6.1 Cystic Fibrosis 223

4.6.6.2 Viral Load Testing 223

4.6.6.3 NMP22 223

4.6.6.4 Trends in Reimbursement Practice 223'/>"/>

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