DRIVING FORCES FOR ADOPTION OF BIOCHIP DIAGNOSTIC PLATFORMS 137
BIOMARKER DISCOVERY AND VALIDATION 137
CLINICAL ACCEPTANCE OF BIOMARKER-BASED TESTS 138
TABLE 60 RATE OF ADOPTION OF DNA MICROARRAY DIAGNOSTICS TESTS 139
MICROARRAY STANDARDIZATION EFFORTS 140
Microarray Quality Control Project 140
External RNA Controls Consortium (ERCC) Study 141
Association of Bimolecular Resource Facilities (ABRF) CGH Microarray Platform Study 142
TABLE 61 COMPARISON OF ARRAY-CGH PLATFORMS 142
OVERVIEW OF MDX 143
INTRODUCTION 143
BENEFITS OF BIOCHIPS AS AN MDX PLATFORM 144
Benefits of Biochips as an MDX Platform (Continued) 145
FIGURE 23 BIOCHIPS TARGET HIGH GROWTH, HIGH MARGIN PORTION OF THE IVD MARKET 146
TABLE 62 BIOTECHNOLOGY DRUGS APPROVED BY THE FDA, 1980–2008 (NUMBER) 147
PHARMACOGENOMICS TESTS 147
Pharmacogenomics Tests (Continued) 148
STRATEGIES FOR COMMERCIALIZING PGX TESTS 149
MDX MARKET PENETRATION CHALLENGES 150
TABLE 63 COMPARISON OF DNA-BASED MDX PLATFORMS 151
TABLE 64 FACTORS AFFECTING PENETRATION OF BIOCHIPS INTO THE MDX MARKET 152
MDX Market Penetration Challenges (Continued) 153
MDX MARKET SEGMENTS 154
MDX TEST SENSITIVITY AND SPECIFICITY 155
FIGURE 24 SENSITIVITY AND SPECIFICITY 156
STATUS OF BIOCHIPS DIAGNOSTICS BY INDICATION 157
SUMMARY OF BIOCHIPS DIAGNOSTICS 157
CANCER OVERVIEW 157
TABLE 65 U.S. INCIDENCE AND TREATMENT DECISIONS FOR SELECTED CANCERS, 2009 157
HEMATOLOGICAL CANCERS 158
BLADDER CANCER 158
BREAST CANCER 159
Breast Cancer Screening 159
Prognosis and Pharmacogenetics Tests 160
FIGURE 25 BREAST CANCER TREATMENT DECISION TREE FOR ONCOTYPE DX 161
TABLE 66 ESTIMATED NUMBER OF ANNUAL BREAST CANCER TREATMENT DECISIONS IN THE U.
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