Molecular Diagnostics: a primer on an emerging sector

This report analyzes the emerging sector of molecular diagnostics. It provides a clear classification, assessing the leading technologies and key tests which are positioned in this exciting area of diagnostics. The current MDx market size and leading players are analyzed, with a market forecast of the MDx segment as well as the total in vitro diagnostic (IVD) market from 2007-13 also provided

Report Highlights
The MDx market is a small but fast growing segment of the global IVD market, with an estimated 2007-13 CAGR of 14.0%. Total MDx sales are expected to outpace the total IVD market (2007-13 CAGR of 5.0%) over the next six years

Of particular interest is the role of MDx in companion diagnostics (the synergy between targeted prescription pharmaceuticals and molecular diagnostic tests). Datamonitor has identified seven key therapeutics and more than 12 MDx tests which exemplify this marriage

The report also details a MDx database containing more than 120 MDx tests. The key tests are positioned in the therapy areas of infectious diseases, hematology and oncology by key MDx players such as Roche Diagnostics, Gen-Probe, Abbott Molecular and Myriad
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CHAPTER 1 EXECUTIVE SUMMARY 2
Key findings 2
What this report will tell you 3
Molecular diagnostic classification 4
Molecular diagnostics regulatory pathway 6
The in vitro diagnostic and molecular diagnostic market sizes 8
Key molecular diagnostic tests 10
Targeted therapies movement fuels MDx development 11
CHAPTER 2 DEFINITION OF MOLECULAR DIAGNOSTICS 16
Key findings 16
Classification of molecular diagnostics 17
Level 1 classification 18
Level 2 classification 18
Level 3 classification 19
Level 4 classification 20
MDx subclassification 21
Key applications of pharmacogenetics - introducing 'personalized medicine' 24
CHAPTER 3 REGULATORY AND DEVELOPMENT PATHWAY 26
Key findings 26
Introduction 27
Classification of devices - US 27
Regulatory pathway 28
Multiple pathways for 'approval' in the US 28
Premarket notification, 510(K) 28
Premarket approval (PMA) 29
Analyte-specific reagent (ASR) 30
Laboratory-developed test - 'home brews' 30
Four strategic routes for approval of a diagnostic test in the US 30
The European Union: Gaining the CE mark 32
Requirements of manufacturers 32
The CE mark 33
Development pathway 34
The diagnostics market is much smaller than the Rx market... 34
...although it can offer some attractions to investors 34
However, there are some downsides... 35
Challenges facing the MDx industry: Intellectual Property 35
CHAPTER 4 THE MOLECULAR DIAGNOSTIC MARKET 37
Key findings 37
Introduction 38
The global in vitro diagnostic (IVD) and molecular diagnostic (MDx) markets 38
Historical IVD and MDx performance, 2001-07 40
Current market: IVD and MDx - the key players 42
The IVD market 43
The MDx market 43
MDx set to increase in importance 48
Introduction to PharmaVitae's MDx database 49
The three broad functions of MDx tests 49
MDx tests for diagnosis 50
MDx tests for risk assessment/predictive 56
MDx tests for drug compatibility 58
Company analysis 60
Therapy area analysis 62
CHAPTER 5 THE KEY MOLECULAR DIAGNOSTIC TESTS 64
Key findings 64
Oncology 65
HER2/neu receptor 65
Invitrogen's Spot-Light 65
Ventana's HER2 Pathway 67
Abbott's PathVysion 69
Siemens's Oncogene ELISA HER2 70
Dako's HER2 ParmDX FISH 71
Dako's HercepTest 72
K-RAS mutation 73
DxS's TheraScreen 73
Genzyme Genetic's KRAS mutations 75
TrimGen's Mutector II KRAS 76
HPV 77
Roche's Amplicor HPV and Linear Array HPV test 77
bioMerieux's NucliSENS Easy Q HPV 79
Qiagen's digeneHPV test 80
EGFR 81
DxS's TheraScreen EGFR29 81
Dako's EGFR PharmDX 82
Estrogen/progesterone receptors 83
Ipsogen's MapQuant Dx 83
Dako's ER/PR PharmDx 85
c-KIT 86
Dako's c-KIT PharmDX 86
Ventana's c-KIT Pathway 87
BCR-abl 88
Cepheid GeneXpert 88
TrimGen's Mutector II BCR-abl 90
UGT1A1 91
ThirdWave's Invader 91
BRCA1/2 93
Myriad's BRAC Analysis 93
p16 gene/CDKN2a 94
Myriad's Melaris 94
MLH1, MSH2, & MSH6 95
Myriad's Colaris 95
DPYD & TYMS 96
Myriad's Theraguide 5FU 96
MLL gene 97
Cytocell's Chromoprobe/Multiprobe 97
uPA & PAI-1 99
American Diagnostica's Femtelle 99
PML-RAR alpha 100
Ipsogen's FusionQuant 100
Various genes/gene profiling 101
Intergenetics OncoVue 101
Genomic Health's OncotypeDx 102
Agendia's MammaPrint 103
Abbott's UroVysion 104
Abbott's CEP 12 DNA probe 106
Abbott's Cep X/Y DNA probe 107
Infectious diseases 108
HIV-1 108
Siemens's Trugene 108
Abbott's m2000 & RealTime HIV-1 viral load test 109
Cobas AmpliPrep/COBAS TaqMan HIV-1 using Amplicor 110
Abbott/Celera's ViroSeq 111
BioMerieux's NucliSENS Easy Q HIV-1 112
HIV-1/2 113
OraSure's OraQuick 113
CXXR4, CCR5-tropic HIV-1 114
Monogram's Trofile Assay 114
Hepatitis C virus 115
Roche's COBAS Ampliscreen HCV test 115
Siemens Versant HCV RNA test 116
Hepatitis B virus 117
Roche's COBAS TaqMan HBV test 117
Cytomegalovirus 118
Roche's COBAS Amplicor CMV monitor test 118
Multiple viral strains 119
BioMerieux's NucliSENS Easy Q technology 119
Abbott through Luminex's xTAG Respiratory Viral Panel (RVP) 120
Cepheid GeneXpert 121
Hematology 122
CYP2C9/VKORC1 122
Nanosphere's Verigene 122
AutoGenomics's Infiniti Warfarin Assay 124
Osmetech's eSensor XT-8 124
Various therapy areas 125
CYP2D6/2D19 125
Roche's Amplichip CYP450 125
CHAPTER 6 APPENDIX 126
Key technologies 126
Other MDx tests 129
Hematology 129
Factor II 129
AutoGenomics's Infiniti Analyzer 129
Roche's Factor II ProThrombin G20210A Kit 129
Factor V Leiden 130
AutoGenomics's Infiniti Analyzer 130
Roche's Factor V Leiden Kit 130
Factor VIII/IX 131
Affinity Biologicals VisuLize FVIII/FIX 131
A-S13 131
American Diagnostica's Immunibind 131
Alpha + / 0 defects 132
BioRad's MDx alpha gene 1 kit 132
Various genes/analytes 132
BioRad's MDx BeTa gene kit 132
Cardiovascular 133
CETP 133
Wako Diagnostics's CETP test 133
Troponin I 134
Nanogen's Cardiac Status 134
Myoglobin, Troponin & CK/IMB 134
Nanogen's 3 in 1 Cardiac Status 134
Acl-H5/Anti-B2GP11 135
American Diagnostica's Imuclone 135
XL-FDP 135
American Diagnostica's D-dimer ActiScreen XI-FDF assay 135
Various genes 136
Clinical data's Famillion test 136
Respiratory 137
CFTR 137
Celera's Cystic fibrosis genotypic assay 137
Third Wave's InplexCF 138
Immunology & inflammation 139
Various genes 139
XDx's AlloMap 139
References 140
Journals 140
Websites 140
Datamonitor Reports 140
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Table 1: The historical IVD and MDx market ($m), 2001-07 40
Table 2: Leading MDx players 45
Table 3: The forecast IVD and MDx market, 2007-13 46
Table 4: MDx tests for diagnosis 50
Table 5: MDx tests for risk assessment/predictive 56
Table 6: MDx tests for drug compatibility 58
Table 7: Invitrogen's SPOT-Light HER2 CISH 65
Table 8: Ventana's HER2 Pathway 67
Table 9: Abbott's HER2 PathVysion 69
Table 10: Siemens's Oncogene ELISA HER2 70
Table 11: Dako's HER2 PharmDX FISH 71
Table 12: Dako's HercepTest 72
Table 13: DxS's TheraScreen 73
Table 14: Genzyme Genetic's KRAS mutation 75
Table 15: TrimGen's Mutector II 76
Table 16: Roche's Amplicor HPV and Linear Array HPV test 77
Table 17: bioMerieux's NucliSENS Easy Q HPV 79
Table 18: Qiagen's digeneHPV test 80
Table 19: DxS's TheraScreen EGFR29 81
Table 20: Dako's EGFR PharmDX 82
Table 21: Ipsogen's MapQuant Dx 83
Table 22: Dako's ER/PR PharmDx 85
Table 23: Dako's c-KIT PharmDx 86
Table 24: Ventana's c-KIT Pathway 87
Table 25: Cepheid GeneXpert 88
Table 26: TrimGen's Mutector II BCR-abl 90
Table 27: ThirdWave's Invader 91
Table 28: Myriad's BRAC Analysis 93
Table 29: Myriad's Melaris 94
Table 30: Myriad's Colaris 95
Table 31: Myriad's Theraguide 5FU 96
Table 32: Cytocell's Chromoprobe/Multiprobe 97
Table 33: American Diagnostica's Femtelle 99
Table 34: Ipsogen's FusionQuant 100
Table 35: Intergenetics OncoVue 101
Table 36: Genomic Health's OncotypeDx 102
Table 37: Agendia's MammaPrint 103
Table 38: Abbott's UroVysion 104
Table 39: Abbott's CEP 8 DNA probe 105
Table 40: Abbott's CEP 12 probe 106
Table 41: Abbott's CEP X/YDNA probe kit 107
Table 42: Siemens's Trugene 108
Table 43: Abbott's m2000 & RealTime HIV-1 viral load test 109
Table 44: Cobas AmpliPrep/Cobas TaqMan HIV-1 using Amplicor 110
Table 45: Abbott/Celera's ViroSeq 111
Table 46: BioMerieux's NucliSENS Easy Q HIV-1 112
Table 47: OraSure's OraQuick 113
Table 48: Monogram's Trofile Assay 114
Table 49: Roche's HCV test 115
Table 50: Siemens's Versant 116
Table 51: Roche's COBAS TaqMan HBV test 117
Table 52: Roche's Cobas Amplicor CMV monitor test 118
Table 53: BioMerieux's NucliSENS Easy Q 119
Table 54: Abbott/Luminex's xTAG RVP 120
Table 55: Cepheid's GeneXpert 121
Table 56: Nanosphere's Verigene 122
Table 57: AutoGenomics's Infiniti Warfarin Assay 124
Table 58: Osmetech's eSensor XT-8 124
Table 59: Roche's Amplichip CYP450 125
Table 60: MDx key technologies 126
Table 61: AutoGenomics's Infiniti Analyzer 129
Table 62: Roche's Factor II ProThrombin G20210A Kit 129
Table 63: AutoGenomics's Infiniti Analyzer 130
Table 64: Roche's Factor V Leiden Kit 130
Table 65: Affinity Biologicals VisuLize FVIII Kit 131
Table 66: American Diagnostica's Immunibind 131
Table 67: BioRad's MDx alpha gene 1 kit 132
Table 68: BioRad's MDx BeTa gene kit 132
Table 69: Wako Diagnostics's CETP test 133
Table 70: Nanogen's Cardiac Status 134
Table 71: Nanogen's 3 in 1 Cardiac Status 134
Table 72: American Diagnostica's Imuclone 135
Table 73: American Diagnostica's D-dimer ActiScreen XI-FDF assay 135
Table 74: Clinical data's Famillion test 136
Table 75: Celera's Cystic fibrosis genotypic assay 137
Table 76: Third Wave's InplexCF 138
Table 77: XDx's AlloMap 139
Figure 1: The four key areas covered in this report 3
Figure 2: PharmaVitae's MDx classification scheme 4
Figure 3: The US vs. EU regulatory pathways 6
Figure 4: The IVD and MDx market size 2007 and 2013f 8
Figure 5: The key MDx tests 10
Figure 6: Datamonitor's classification of 'molecular diagnostics' 17
Figure 7: MDx subclassification 21
Figure 8: The connection of diagnostics with prescription pharmaceuticals 24
Figure 9: US classification of medical devices 27
Figure 10: The global IVD and MDx markets ($m), 2001-13 38
Figure 11: Historical absolute growth of the IVD and MDx sectors ($m), 2001-07 41
Figure 12: Approximate market share of IVD and MDx markets, 2007 42
Figure 13: Forecast absolute growth of the IVD and MDx sectors ($m), 2007-13 47
Figure 14: The increasing importance of MDx to the total IVD market 48
Figure 15: Split of MDx test function 49
Figure 16: Count of MDx companies with multiple tests 60
Figure 17: Count of MDx tests by therapy area 62
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