JSB Market Research - MediPoint: Companion Diagnostic Tests in Oncology - Global Analysis and Market Forecasts
A companion diagnostic test is defined as an in vitro diagnostic device or an imaging tool whose use allows the safe application of a therapy. In-vitro Companion Diagnostic tests measure the expression or presence of a specific biomarker that is linked to a disease condition or therapy.
A companion diagnostic test is defined as an in vitro diagnostic device or an imaging tool whose use allows the safe application of a therapy. In-vitro Companion Diagnostic tests measure the expression or presence of a specific biomarker that is linked to a disease condition or therapy.
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3.4.4 Selection of Partner 59<br />
3.4.5 Biomarker Discovery 61<br />
3.5 Cl<strong>in</strong>ical Outcomes 62<br />
3.5.1 Role of <strong>Companion</strong> <strong>Diagnostic</strong>s <strong>in</strong> Disease Treatment 62<br />
3.5.2 <strong>Companion</strong> <strong>Diagnostic</strong> Test Applications 63<br />
3.6 Test<strong>in</strong>g Trends 64<br />
3.6.1 US 64<br />
3.6.2 France 75<br />
3.6.3 Germany 85<br />
3.6.4 Italy 92<br />
3.6.5 Spa<strong>in</strong> 100<br />
3.6.6 UK 106<br />
3.6.7 Japan 120<br />
3.6.8 Brazil 129<br />
3.6.9 Ch<strong>in</strong>a 135<br />
3.6.10 India 143<br />
3.7 <strong>Market</strong> Access 150<br />
3.7.1 Overview 150<br />
3.7.2 US 150<br />
3.7.3 5EU 154<br />
3.7.4 Japan 165<br />
3.7.5 Brazil 167<br />
3.7.6 Ch<strong>in</strong>a 169<br />
3.7.7 India 172<br />
3.8 Regulatory Issues <strong>and</strong> Recalls 173<br />
3.8.1 Dako FDA Warn<strong>in</strong>g Letter 173<br />
3.8.2 HercepTest Recall 174<br />
3.8.3 Cobas KRAS Test Recall 174<br />
3.8.4 Cobas BRF V600E Test Recall 174<br />
3.8.5 Leica Bond HER2 IHC System 174<br />
3.9 Reimbursement of <strong>Companion</strong> <strong>Diagnostic</strong> <strong>Tests</strong> 175<br />
3.9.1 US 175<br />
3.9.2 Europe 180<br />
3.9.3 APAC 192<br />
3.9.4 South America 197<br />
3.10 M&A, Key Partnerships 199<br />
3.10.1 Significant Mergers <strong>and</strong> Acquisitions 201<br />
3.10.2 Recent Partnerships 201<br />
3.11 Economic Impact 207<br />
3.11.1 Cost Effectiveness of <strong>Companion</strong> <strong>Diagnostic</strong>s 207<br />
3.11.2 Cost Effectiveness of <strong>Companion</strong> <strong>Diagnostic</strong>s: Healthcare Provider Perspective 208<br />
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