Contents:

Introduction Part 1 – France 1 Current Situation 1.1 Respondent Population France 1.2 Nucleic Acid Based Testing 1.3 Genetic Testing - Routine or Research 1.4 HPV Testing 1.5 Oncology Markers 1.5.1 Solid Tumor Marker 1.5.2 Lymphoid Tumour Marker 1.6 Nucleic Acid Sample Preparation 1.7 Trends in NA-Based Oncology Diagnostics 1.7.1 Emerging Markers 1.7.2 CE approval 1.8 NAT - application and technical appraisal 1.9 Politics and Reimbursement 1.9.1 Drivers of NAT 1.9.2 Restraints on NAT 1.10 Summary and Conclusions Part 2 – Germany 2 Current Situation 2.1 Respondent Population Germany 2.2 Nucleic Acid Based Testing 2.3 Genetic Testing - Routine or Research 2.4 HPV Testing 2.5 Oncology Markers 2.5.1 Solid Tumor Marker 2.5.2 Lymphoid Tumor Marker 2.6 Nucleic Acid Sample Preparation 2.7 Trends in Genetics Based Oncology Diagnostics 2.7.1 Emerging Markers 2.7.2 CE certification 2.8 NAT - application and technical appraisal 2.9 Politics and Reimbursement 2.9.1 Drivers of NAT 2.9.2 Restraints on NAT 2.10 Summary and Conclusions Part 3 – Italy 3 Current Situation 3.1 Respondent Population – Italy 3.2 Nucleic Acid Based Testing 3.2.1 Types of testing performed 3.3 Genetic Testing - Routine or Research 3.4 HPV Testing 3.5 Oncology Markers 3.5.1 Solid Tumor Marker 3.5.2 Lymphoid Tumor Marker 3.6 Nucleic Acid Sample Preparation 3.7 Trends in NA-Based Oncology Diagnostics 3.7.1 Emerging Markers 3.7.2 CE or FDA approval 3.8 NAT - application and technical appraisal 3.9 Politics and Reimbursement 3.9.1 Drivers of NAT 3.9.2 Restraints on NAT 3.10 Summary and Conclusions Part 4 – United Kingdom 4 Current Situation 4.1 Respondent Population UK 4.2 Nucleic Acid Based Testing 4.3 Genetic Testing - Routine or Research 4.4 HPV Testing 4.5 Oncology Markers 4.5.1 Solid Tumor Marker 4.5.2 Lymphoid Tumor Marker 4.6 Nucleic Acid Sample Preparation 4.7 Trends in NA-Based Oncology Diagnostics 4.7.2 Emerging Markers 4.7.3 CE certification 4.8 NAT - application and technical appraisal 4.9 Politics and Reimbursement 4.9.1 Drivers of NAT 4.9.2 Restraints on NAT 4.10 Summary and Conclusions Part 5 – USA 5 Current Situation 5.1 Respondent Population US 5.2 Nucleic Acid Based Testing 5.2.1 Types of testing performed 5.3 Genetic Testing - Routine or Research 5.4 HPV Testing 5.5 Oncology Markers 5.5.1 Solid Tumor Marker 5.5.2 Lymphoid Tumor Marker 5.6 Nucleic Acid Sample Preparation 5.7 Trends in NA-Based Oncology Diagnostics 5.7.1 Emerging Marker 5.7.2 Test Certification 5.8 NAT - application and technical appraisal 5.9 Politics and Reimbursement 5.9.1 Drivers of NAT 5.9.2 Restraints on NAT 5.10 Summary and Conclusions

Methodology

Interview numbers were selected to ensure an accurate representation of the country laboratory structures, which vary widely and are described within the report. The study focuses on institutions that have a specialization in Oncology and Molecular Diagnostics. There is no differentiation between public and private laboratories; however, where differences, relevant for the analysis were found to be obvious, these are highlighted. Target respondents were Heads of Departments or senior personnel able to provide sufficient qualitative answers based upon their experience within the clinical diagnostic laboratory setting. The information gathering was carried out blind. To support the primary data the author utilised a combination of internal and external secondary data to provide further input to the overall analysis. To allow an interpretation for the whole market segment, the findings from primary research were projected onto the base population (laboratories performing nucleic acid based testing in oncology) which was determined by the first level of primary research in the form of snapshot interviews. Interviews were conducted with respondents within at least 16 laboratories per country.