Advances in the Use of Biomarkers in Biochip and Microarray Testing: Innovative technologies, growth opportunities and the future market outlook

Microarrays and biochips are small devices capable of detecting and measuring large numbers of biomarkers simultaneously. Although microarrays have been in research use for over a decade it is only recently that they have moved towards meeting the requirements of the clinical and regulatory communities with the first DNA microarray test being approved by the US FDA in 2007. Further development of microarrays heralds the introduction of faster diagnosis times and will further enable personalized medicine. This report covers future developments in key segments of the microarray market including DNA, protein, tissue and cell microarrays and lab-on-a-chip technologies, providing market forecasts to 2013. In addition the report gives insights into the developmental programs of 45 leading players in this market.
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Table of Contents
Advances in the use of biomarkers in biochip and microarray testing
Executive Summary 12
Biochips, biomarkers, and in vitro diagnostics 12
DNA microarrays 13
Protein microarrays 14
Tissue and cell microarrays 16
Lab-on-a-Chip technologies 17
Biochip companies 18
Market Analysis and Forecasts 18
Chapter 1 Biochips, biomarkers, and in vitro diagnostics 22
Summary 22
Biomarker-based IVDs 23
Introduction to biochips 23
Microarrays 23
Microfluidic chips 24
Background on nucleic acid and protein testing 25
Immunoassay technology 25
Immunoassay formats 26
Rapid immunochromatographic assays 28
Multiplexed assays 28
Nucleic acid testing 29
Probe-based NAT 30
Amplification technologies 32
Biomarker discovery and validation 33
Translating biomarkers into IVDs 35
Regulation of in vitro diagnostics 36
Europe 37
USA 37
Draft guidance on multivariate analysis 40
Chapter 2 DNA microarrays 44
Summary 44
Introduction 46
DNA microarray fabrication technologies 49
Standard microarrays 49
3-D DNA microarrays 53
Particle (bead)-based microarrays 54
Analytical uses of DNA microarrays 56
SNP genotyping 56
Detection of genetic imbalances 57
Gene expression profiling 59
Single-channel microarrays 60
Two-channel microarrays 62
Methods utilizing RT-PCR 64
MicroRNA expression profiling 65
Limitations and barriers to commercialization 66
Key commercial players 69
DNA microarray testing in cancer 70
Overview 71
Progress in breast cancer 74
Early detection 74
Classification, prognosis, and treatment 75
Tumors of unidentified origin 79
Other advances 80
DNA microarray testing in genetic disorders 82
Microarrays testing for adverse drug reactions 86
DNA microarray testing in transplant management 87
DNA microarray testing in other conditions 88
Expanding applications 91
Chapter 3 Protein microarrays 94
Summary 94
Introduction 96
Background on proteomics 97
Protein microarray technologies 100
Formats 102
Glass slides 102
Microwell/nanowell chips 103
Implementation 103
3.3.2.1 Forward-phase microarrays 103
Prospects for multiplex ELISAs 104
Reverse-phase microarrays 105
Detection of bound targets 106
SELDI ProteinChip technology 107
Fabrication technologies 109
Dispensing technology 109
Protein immobilization strategies 110
Surface chemistries 111
Analytical uses of protein microarrays 113
Commercial microarrays for clinical research 114
Protein microarray diagnostics in cancer 118
Chapter 4 Tissue and cell microarrays 124
Summary 124
Introduction 125
Tissue microarrays 127
Advantages 127
Construction 128
Sources of tissue 129
Scanning and analysis 130
Companies providing products and services 131
Uses of tissue microarrays 132
Clinical investigations in cancer 134
Initiatives using cell microarrays 135
Overview 135
Examples of diagnostic applications 137
Chapter 5 Lab-on-a-Chip Technologies 140
Summary 140
Introduction to microfluidics 141
Lab-on-a-chip devices 144
Construction methods 145
Companies and technologies 146
Multiplexed particle assays 150
Multiplexing at the microlevel 151
Particle encoding technologies 152
Applications of LoC devices 153
Changing diagnostics 154
Future role in PoC testing 155
Chapter 6 Biochip companies 160
Introduction/Summary 160
Accelr8 Technology Corporation 160
Company description 160
Microarray-based rapid bacterial analysis 161
Advanced Liquid Logic Inc 162
Company description 162
Digital Microfluidics devices 163
Affymetrix Inc 164
Company description 164
DNA and protein microarrays 165
Agendia BV 167
Company description 167
Gene expression microarray diagnostics 167
MammaPrint 167
TargetPrint 168
CupPrint 168
ColoPrint 168
Agilent Technologies Inc 169
Company description 169
DNA microarrays 169
Almac Group Ltd 170
Company description 170
Microarray-based gene expression profiling 171
Ambry Genetics Corp 171
Company description 171
Microarray-based cytogenetic testing 172
Applied Microarrays Inc 172
Company description 173
3-D DNA microarrays 173
Arrayit Corp 174
Company description 174
Universal DNA microarray-based diagnostics 174
ArrayXpress Inc 176
Company description 176
Microarray services 176
Atactic Technologies Inc 177
Company description 177
Specialty microarrays 177
Aushon BioSystems Inc 178
Company description 178
Protein microarrays and services 178
AutoGenomics Inc 179
Company description 179
3-D DNA microarrays for diagnostics 179
Beecher Instruments Inc 180
Company description 180
Tisue microarray products and services 181
BioArray Solutions Ltd 182
Company description 182
Bead-based microfluidic arrays 182
BioDot Inc 183
Company description 183
Protein biochip manufacture 183
Caliper Life Sciences Inc 184
Company description 184
Microfluidic lab-on-a-chip systems 184
CapitalBio Corp 185
Company description 185
Microarray systems and diagnostics 185
CombiMatrix Corp 187
Company description 187
DNA microarray technology and diagnostics 188
Cybrdi Inc 190
Company description 190
Tissue microarray products and services 190
Decision Biomarkers Inc 191
Company description 191
Microarrays for multiplex immunoassays 191
Epigenomics AG 192
Company description 192
Methylation microarrays for diagnostics 192
ExonHit Therapeutics SA 193
Company description 193
Differential gene expression profiling 194
Expression Analysis Inc 195
Company description 195
DNA microarray-based testing services 195
GeneNews Ltd 196
Company description 196
Gene expression diagnostics 196
GenTel BioSciences Inc 197
Company description 197
Protein microarrays and research kits 197
Illumina Inc 199
Company description 199
Bead-based microarrays 199
Imgenex Corp 200
Company description 200
Tissue microarrays 201
Iris BioTechnologies Inc 201
Company description 201
DNA microarrays for diagnostic profiling 201
LC Sciences LLC 203
Company description 203
Microarray products and services 203
Life Technologies Corp 204
Company description 204
Microarray/microfluidic research tools 204
Luminex Corp 205
Company description 205
Bead suspension microarrays and diagnostics 205
Maxwell Sensors Inc 207
Company description 207
Microarray and microfluidic products 207
Med BioGene Inc 208
Company description 208
Gene expression microarrays for diagnosis 208
Micronics Inc 209
Company description 209
Disposable microfluidic diagnostic labcards 209
Micronit Microfluidics BV 210
Company description 210
Microfluidic glass chips 211
Oxford Gene Technology Ltd 211
Company description 211
DNA and protein microarrays 212
Protein BioTechnologies Inc 212
Company description 212
Protein and tissue microarrays 212
Response Genetics Inc 213
Company description 213
Microarray gene expression cancer testing 213
Roche NimbleGen Inc 214
Company description 214
DNA microarray products and services 215
SABiosciences Corp 217
Company description 217
DNA microarrays and RT-PCR arrays 217
Signature Genomic Laboratories LLC 218
Company description 218
Microarray-based cytogenetic diagnostics 218
SomaLogic Inc 219
Company description 219
Aptamer microarrays 219
US Biomax Inc 220
Company description 220
Tissue microarrays 220
Xceed Molecular Corp 221
Company description 221
3-D DNA microarrays 222
Chapter 7 Market analysis and forecasts 224
Summary 224
Introduction 225
DNA microarray review 226
Market history 226
Some leading players 228
Market growth 230
Protein microarray review 232
Market history 232
Some leading players 234
Market growth 235
Market segmentation and forecasts 235
Market prospects 241
Chapter 8 Appendix 1 Abbreviations and
Acronyms 246
Scientific/technical/medical terms 246
A2.2 Institutional/regulatory terms 247
Chapter 9 Appendix 2 Research
Methodology 250
Index 251
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List of Figures
Figure 1.1: Non-competitive “sandwich” assay 27
Figure 2.2: An approx 18,000-test gene microarray 46
Figure 3.3: Principle of a spatially addressable protein microarray 106
List of Tables
Table 2.1: Companies featured in Chapter 2 48
Table 2.2: DNA microarray technologies/products 49
Table 2.3: Systems for gene expression profiling 59
Table 2.4: Gene expression tests in breast cancer 70
Table 2.5: Other cancer tests 71
Table 2.6: DNA microarray testing in genetic disorders 82
Table 3.7: Companies featured in Chapter 3 97
Table 3.8: Protein microarray technologies/products 102
Table 3.9: Protein microarrays for clinical research 114
Table 3.10: Protein microarray-enabled cancer diagnostic discovery 118
Table 4.11: Companies and products featured in Chapter 4 126
Table 5.12: Companies and products featured in Chapter 5 143
Table 7.13: Microarray Industry Bibliometric Output, 2000-2008 231
Table 7.14: Snapshot of FDA approved in vitro diagnostic microarray products 237
Table 7.15: Microarray Forecasts ($m) 240
Table 7.16: Leading Company Market Shares 241
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