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1. WG DN2. TDNA FDA 3
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30. RZE C 1 2 Warfarin MOP VHB 2 88 PubMed ID 16444443 10718793 8913415 TPMT Var iants 1PM TPMT TPWT
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34. DNWA FDA CYP450 2 CYP2D6 CYP2C19 DNA IW DA Amalyte Specific Reagent ASR ee AR FDA FDA CLIA
35. 280 390 950 A 41 cDNA 1 2 Clontech 3 4 Stratagene 1 3 03 cDNA 2 4 Alexa bbb cDNA 914m 570m B Fluolid Orange cDNA 1 Clontech 2 Stratagene 488m 590m 33 4 2 cDNA DA A Cy3 cDNA 532m 570m 8 Fluolid Orange cDNA 473m 570m Clontech Atlas PowerScript Fluorescent Label ing Kit 34 5 4 WG
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37. 4 2 DA m Cy3W Mono reactive dye pack Amersham 550 570 20 Biosciences Cy5W Mono reactive dye pack Amersham 649 670 20 Biosciences Alexa Fluor 555 reactive dye Invitrogen 555 565 10 decapack Alexa Fluor 647 reactive dye Invitrogen 650 670 10 decapack DY 550 NHS Ester Dyanics 553 578 1 mg DY 635 NHS Ester Dyanics 647 671 1 me Fluol id Orange IST 460 594 1 me 4 4 1 3l 2 1 Clontech Stratagere cDNA cDNA 6 5 IE 0 5 Fluolid Orange 5 29 6 FluorImagerW595 Molecular Dynamics
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50. DA http ww kurabo co jp nbd array index html http ww kurabo co jp nbd array specif ication html 109 http Ww kurabo co jp nbd array human html 114 http Ww kurabo co jp nbd array rat html VORA L4 BRET 132 http ww kurabo co jjp nbd array mouse html DA 9 A 3 DMAA 9 http news genk i book jp 3diseases prp 29 002210 php
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63. QLONTEH Atlas PowerScript Fluorescent Label ing Kit Stratagene Fair Microarray Labeling Kit Oy3 Alexa 555 Fluolid Orange 3 Clontech 4 3 4 2 Q3 5 Alexa Cy dwe y dye Fluolid IST 120 140 m DNA
64. DNA 2005 14 12007 amp Fuji Keizai US DNA a 1 2 OWN 1 2 1 10K 1 PMA 2 IE 1 7 4
65. PD 5 DPD 3 Capecitabine 5 Fluorouraci Cream m26 Fluorouracil Topical Solution amp Cream m27 2 88 PubMed ID 16428499 16163233 15377401 15093568 15083629 EGFR expression EGR EGFR EGFR pharmaDxIM pharm Dx 1 EGFR 109653 EGFR ER 0 68 24
66. e 11 2 2 6 11 227 HH HH Hh 12 2 2 8 tterrrrererererrrrererererererrrrerrrererrererererererrerese 12 2 3 mH HH Hn 12 231 v n n n nnn m Henn 12 2 3 2 Hn 12 2 3 3 cmm mn 13 2 3 4 pp 13 235 RII 13 2 3 6 1 13 2 3 7 13 2 3 8 cttm Hn 13 239 14 NG ae ER Aes UA RE a a eee Dea gait 14 242 S nnn 14 2 5 15 3 DNMA 16 3 1 DNA eee e In nnn 16 dd BPI ee od A tene ee ad ee ere re eee ere Te 16 3 1 2
67. ApliChip FDA 2 3 2
68. Alexa Fluor Alexa Fluor Alexa Fluor Alexa Fluor pH http Aww invitrogen co jp catalogue molecular probes alexa alexa index html DMA Alexa Fluor 546 Cy3 3 Alexa Fluor Cy Alexa Fluor dye swap y
69. Cy Dye QNIP cDNA CDNA Cy Dye 30 mA cDNA cDNA dUTP cDNA NN oDN cDNA 2
70. IM 2 Azathioprine Thioguanine m33 Mercaptopurine m34 27 PubMed ID 16409140 16267626 15792824 15571264 15570193 15316356 15226673 14985890 12465143 10628931 1857117 UGTIAT Variants UTIA UGTIAK28 allele 2 Irinotecan 288 PubMed ID 15297419 15280927 15007088 15084617 28 3 3 3
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72. FDA NR 2003 11 DNA FDA DAR DNA AS DA FDA DNA AR DNA DW
73. 288 PubMed ID 12851888 16226710 16294026 2 CYP2C19 Var iants CYP2C19 3 Poor Metabolizers PM Extensive Metabol izers B In vivo CYP2C19 15 2096 PM PM 3 59 6 P ACT 4 2 3 Voriconazole Oneprazole mi Pantoprazole m2 Esameprazole m3 diazepamlm MNelfinavir mb Rabeprazoleln6 Aa PubMed ID 12867215 11866669 CY
74. SMPs DNA 45 DNA FDA SNPs
75. OC WA DC 5 2 5 1 Guidance for Industry and FDA Staff Class Special Controls Guidance Document Drug Metabol izing Enzyme Genotyping Systen U S Food and Drug Adninistration 2 AT 16 8 3 0803002 3 The First Genetic Testing Quality Control Materials Program GIQO Expert Panel Meeting November 29 2005 Turnhout Belgium 4 PR 1997 6 15 5 Genetic Testing Quality Control Materials ProgranDevelooment of verified QC materials for genetic testing April 5 2005 6 The Condensed Protocols 467 7 1 8 DW 3 DNA DM
76. 4 1 2 1 cDOW 65C FLA 8000 FujiFilm 4 2 3 CyG Alexa 555 Fluolid Orange cDW 4 1 Alexa 555 cDW Qy3 Cy3 Alexa 555 cDW Fluolid Orange cDNA Tzs 4 2 Oy3 cDNAN DNA Fluolid Oranee Cy 4 Clontech
77. DNA CYP2C19 2D6 SNPs DNA FDA DNA 2 2 2 1 DNA DNA DNA DNA 2 2 3 DN DM DNA
78. DMA DM DNA DNA 3 1 DNA 3 1 1 DNA 3 1 2 2006 11 H 2007 2 H 3 1 3 DNA DM F
79. MammaPrint multiplex POR DNA DMA 2 DNA 1
80. SNP 2 4 2 DNA 2 4 2 1 1 SNP SNP S NP
81. DNA 3 DM OR http Aww 3d gene coWpoint basis html S 1 mRNA DNA
82. DNA gold standard method 1 3 DNA DNA DA
83. Alexa Fluor Cy DNA 17 DNA UIP 21664 dP DA Alexa Fluor 555 Alexa Fluor 647 421677 21676 Cy3 Cyd Alexa Fluor Cy DNA 21 110 4 DM Fy De ARES DNA
84. EGR 1 Cetuximeb SOON Gefitinib n28 2 88 PubMed ID 16354869 16336755 16336752 16117976 16061873 15962524 15863375 15946581 15677699 15217966 G6PD Deficiency glucose phosphate dehydrogenase G6PD G6PD COPD Rasburicase G6PD Contradictions Warnings Hemolysis 3 Rasburicase Dapsone m9 2 88 PubMed ID 16204390 11842483 G6PD Deficiency with alternate Context 25
85. 10096 10096 10096 MPs DNA C 0 9 50 500 3 2007 amp Affwretrix 39 4 DNA
86. 3 3 2 FDA Genomics Biomarker FDA Valid Genanic Biomarkerk 18 Table of Valid Genanic Biomarkers in the Context of Approved Drug Labels http Aww fda gov cder genanics genomic_biomarkers_table htm o Genomic Biomarker FDA 6Genomic Biomarker Genomic Biomarker 1 2 3
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89. Q DNA DNA DNA 3 DA DA DAN OEE DNA DA DNA
90. FDA 510 8 Modern Drug Discovery ASR FDA SHOW
91. 288 PubMed ID 16445668 16277882 16137435 15725114 15143970 14990641 MT Variants NF AT OD slow acetylator fast acetylator slow acetylation 3 Rifampin isoniazid and pyrazinamide Isosorbide dinitrate and Hydralazine hydrochloridelm31 2 88 PubMed ID 12669770 12715953 2224079 12271964 11259359 11677864 15951616 Philadelphia Chramosame Deficiency 2 4 27T 74 X RAAB LISSE Z4 DTI 4 PRA PhD ML Ph1 M CML 3 26 Busulfan 2006
92. HY ME RNA MgmmaPrint DNA FDA 70 DNA
93. DNA DNA DMA DM DNA 5
94. pp 16 21 3 e n e e III 16 3 1 4 pp 16 3 1 41DNA c 16 3 1 4 2 DNA e 18 3 1 4 3 DNA e III 18 3 1 5 ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee 1 9 3 1 5 1 19 3 1 5 2 19 3 1 5 3 PC 1 9 3154 20 32 ee 20 22 BM rc rerum 20 3 2 2 DNA S 20 32 3 DMNA 20 3 3 II Hh hn 22 331 Bl hh hh hh hr 22 3 3 2 FDA 6Genomics Biomarker sem 22 3 3 3
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96. MA 1 8 20 FDA 9 19 NATURE BIOTECHNOLOGY 2006 9 AS Vol 24 No 9 21 J Natl Cancer Inst 2007 99 147 157 1 FDA 5 DM 2004 3 16 A Guidance for Industry and FDA Staff Class Special Controls Guidance Document Factor V Leiden DNA Mutation Detection Systems 2 CYP2C19 Aml iChip CYP450 Test 510 k 2005 1 10 H Aplihip CYP450 Test for CYP2C19 510 k Summary 3 510 510 Substantial Equivalence Determination Decision Summary Assay only Template 4 510 510 k Substantial Equivalence Determination Decision Summary Assay and instrument Combination Temlate 5 FDA 2005 3 108 Guidance for Industry and FDA Staff Class Special Contro
97. FDA MAQC DW JBA 1 4 3 DNA W 19 1 18 1 DNA
98. ttp ww fda gov cdrh oivd guidance 1210 html FDA DNA htto Ww fda gov oc initiatives criticalpath Wnitepaper html DMA DNA F DNA DNA
99. Modern Drug Discovery FDA 2004 6 1 2 3 FDA II FDA Class Special Controls Guidance Document Drug Metabol izing Enzyme Genotyping System 1 Class Special Control http ww fda gov cdrh devadvice 3132 html 2 FDA 1040
100. 0 42 2 NSCLC 326 4596 EGFR EGFR 3 Erlotinib PubMed ID 16354309 16011858 EGFR expression with alternate Context ETR SOON EGR 3 Cetuximab SOON Gefitinib m8 2 88 PubMed ID 16354869 16336755 16336752 16117976 16061873 15962524 15863375 15946581 15677699 15217966 EGFR expression with alternate Context ETR DakoCytomation EGFR pharmDx
101. 1 3 2 DNA W 18 11 29 1 5 11 24 DNA WG 38 3 WG tzo 2 DA
102. Al oMap XDx 20 2 950 ChemoFx Precision 450 Therapeutics IHC ManmaPr int Agendia DNA gt 3 000 70 Oncotype DX Genomic RI PCR 3 460 Health ILO 21 Phenosense GT Monogram HIV HIV HIV 1 460 Biosciences Newwave diagnostics Nature Biotechnology Volume 24 Nurber 8 August 2006 29 4 4 1 aRW DA
103. DNA DNA DN 20 0 60 212 DNA DNA
104. G6PD G6PD G6PD nicotinamide adenine dinucleotide NADH methemoglobin reductase deficiency 3 Primaouine Chloroquine m0 PubMed ID 15330059 P15117307 P12643993 9685977 2 Her2 neu Over expression Her2 neu Her2 neu INDICATIONS HR PRECATIONS HER2 HH Testing 1 Trastuzumb
105. The MicroArray Quality Control MAGC project shows inter and intraplatform reproducibility of gene expression measurements MAQC Consortium 18 NATURE BIOTECHNOLOGY Vol 24 No 9 2006 1123 1131 RNA Richard Shippy Stephanie Fulmer Smentek Roderick V Jensen Wendell D Jones4 Paul K Wolber Charles D Johnson P Scott Pine Cecilie Boysen Xu Guo8 Eugene Chudin Yongming Andrew Sun James C Willey Jean 50 Thierry Mieg Danielle Thierry Mieg Robert A Setterouist Mike Wilson Anne Bergstrom Lucas Natalia Novoradovskaya Adan Papallo Yaron Turpaz Shawn C Baker Janet A Warrington Lening Shi amp Danir Herman Using RNA sample titrations to assess microarray platform performance and normal ization techniques 19 NATURE BIOTECHNOLOGY Vol 24 No 9 2006 1140 1150 WAQCOO 2 Tucker A Patterson Edward K Lobenhofer Stephanie B Fulmer Smentek Patrick J Collins Tzu Ming Chu Wenjun Bao Hong Fang Ernest S Kawasaki Janet Hager Irina R Tikhonova Stephen J Walker Liang Zhang Patrick Hurban Francoise de Longueville James C Fuscoe Weida Tong Leming Shi amp Russell D Wolfinger Performance compar
106. DMA DMA 4 2 DMA 19 3 2 0 35 1 OA WG 1 1 1 OWN NG 18 10 3 1 WG WG
107. CX Valid Biomarker Guidance for Industry Pharmacogenomic Data Submissions A biomarker that is measured in an analytical test system with well established performance character istics and for which there is an established scientific framework or body of evidence that elucidates the physiologic toxicologic pharmacologic or clinical significance of the test results The classification of biomarkers is context specific tGenomic Biomarker ICH Current Step 2 version dated 25 Oct 2006 A genomic biomarker is defined as A measurable DNA or RNA characteristic that is an indicator of normal biologic processes pathogenic processes and or response to therapeutic or other intervention CD C KIT expression 22 cKit In vitro c kit GIST KIT CO117 GIST 3 Imatinib mesylate KIT 017
108. 10 PubMed ID 11919388 PML RAR alpha gene expression Retinoic acid receptor responder and non responders PL RARo APL APL t 15 17 PML RARw ML 3 Tretinoin Arsenic Oxide m32 2 88 PubMed ID 15735696 11114710 Protein C Deficiencies hereditary or acquired C S S
109. NACB National Academy of Clinical Biochemistry Pharmacogenetics Practice Guidelines
110. 41 DNA RW 1 2
111. Total RNA cDNA cDNA 20 1 W 3 Alexa Fluor 555 Alexa Fluor 647 R 0 9956 0 9915 0 9906 Cy3 Cy5 R O 9380 0 9654 0 9566 http ww invitrogen co jp catalogue molecular probes microarray contentO2 index html 3 3 3 3 1 DNA FDA 6Genomics Biomarker DNA
112. DA 2006 12 14 DNA QOL http Aww sysmex co jp news press 2006 061214 html 3 1 43 DA CD LAP LAWP 6 4 DM 65C 1 DNA 15 1 1W 10
113. DNA DNA 5 2 2 6 1 D
114. Labs Devi ipment PerkinElmer Devi L amp AS led ca umen avn 8 E EN m 2 3 kag virgen Reasons 5 1 885 ee fae 1 s we Fass ser ee PT pe TIS m 2 c 7 ment Caliper Life Devi 87 Sciences kud Somas pode mes oevee 2 735 i Clontech 13 Takara Bio Whatman S amp S 6 9 Biosciences Telechem Private International Array it Private Pubic 31 122 ve 26 Srono me Sawer Deves me eo p pmomes Doves 10 61 7 7 0 7 ejej 8 8 2 z e o Rege 3j elle sse eles ng 1 me epe cl Biochip Affymetrix Device DNA biochips Scanner Semiconductor manufacturing methods Biochip GE Healthcare Device CodeLink biochips reagents 858 Bioscience equipment methods Equipment PerkinElmer L amp AS Device Equipment reagents used in DNA eee Content Sigma Aldrich Reagents Reagents for sample prep ee Equipment Applied Biosystems Device Biochips reagents equipment 228 Equipment Tecan Device Scanning automated hybridizing Biochip Whatman S amp S Coatings to glass slides arraying Biosciences glass making Equipment Caliper Life Sciences Lab automation robotics integration to liquid handling equipment Biochip Device Bead based biochip methods scanner design optical detection Oligator oligo synthesis meth
115. 6 1 1 1 4 MG 7 WG
116. HAR SH Me ABE PAAR U ANI 7 A S s e gie dt DR Have BE NP ZEE SR DR aN amp 1t 44 TORS S em De HRANE modom sec gt HITE 18 1 8 DNA WG 19 3 DN A WG x te GE DM WG
117. NA microarray results with quantitative gene expression platforms 15 NATURE BIOTECHNOLOGY Vol 24 No 9 2006 1132 1139 RA Weida Tong Anne Bergstrom Lucas Richard Shippy Xiachui Fan Hong Fang Huixiao Hong Michael S Orr Tzu Ming Chu Xu Guo Patrick J Collins Yongning Andrew Sun Sue Jane Wang Wenjun Bao Russell D Wolfinger Svetlana Shchegrova Lei Guo Janet A Warrington amp Leming Shi Evaluation of external RNA controls for the assessment of microarray performance 16 NATURE BIOTECHNOLOGY Vol 24 No 9 2006 1162 1169 Lei Guo Edward K Lobenhofer Charles Wang Richard Shippy Stephen C Harris Lu Zhang Nan Mei Tao Chen Damir Herman Federico M Goodsaid Patrick Hurban Kenneth L Phillips Jun Xu Xutao Deng Yongming Andrew Sun Weida Tong Yvonne P Dragan amp Leming Shi Rat toxicogenamic study reveals analytical consistency across microarray platforms 17 NATURE BIOTECHNOLOGY Vol 24 No 9 2006 1151 1161 MO MAQC
118. P209 Var iants CYP2C9 PM EM P450 209 PM PM 3 Celecoxib 00X 2 Warfar inim 88 PubMed ID 16118328 15637526 15714076 15037866 14558433 CYP2D6 Var iants CYP2D6 CYP2D6 PMs EMs 23 3 Atomoxetine Venlafaxine m8 Risperidone m9 Tiotropium bromide inhalation m1O Tamoxifen m11 Timolol Maleate m12 PubMed ID CYP2D6 with alternate Contex
119. atory setting COMVENTARY 11 NATURE BIOTECHNOLOGY Vol 24 No 9 2006 1105 1107 Nurber of submissions FDA Felix W Frueh Impact of microarray data quality on genomic data submissions to the FDA 12 NATURE BIOTECHNOLOGY Vol 24 No 9 2006 1108 1111 David J Dix Kathryn Gallagher William H Benson Brenda L Groskinski J Thomas McClintock Kerry L Dearfield amp William H Far land A framework for the use of genomics data at the EPA 13 NATURE BIOTECHNOLOGY Vol 24 No 9 2006 1112 1113 Hanlee Ji amp Ronald W Davis 49 Data quality in genamics and microarrays 14 NATURE BIOTECHNOLOGY Vol 24 No 9 2006 1115 1122 DA v Roger D Canales Yuling Luo James C Willey Bradley Austermiller Catalin C Barbacioru Cecilie Boysen Kathryn Hunkapiller Roderick V Jensen Charles R Knight Kathleen Y Lee Yunging Ma Botoul Magsodi Adam Papallo Elizabeth Herness Peters Karen Poulter Patricia L Ruppel Raymond R Samaha Leming Shi Wen Yang Lu Zhang amp Feder ico M Goodsaid Evaluation of D
120. ison of one color and two color platforms within the MicroArray Quality Control WAQO project 20 2006 11 Recomendations for the Generation and Submission of Genomic Data Concept Paper 21 J Natl Cancer Inst 2007 99 147 157 Critical Review of Published Microarray Studies for Cancer Outcome and Guidelines on Statistical Analysis and Reporting Alain Dupuy Richard M Simon 51 22 2007 amp Fuji Keizai USA nnet s DNA Biochip DNA Biochips Service Centers Commercial DNA RNA YA Commercial amp Core Labs SOx Genotypi y Biochips Catalog Deom Splice Variant aCGH ChIP on Chip CPG Island miRNA Reagent Kits 52 xar 24767 27813 amaa snas ra vo 1 DNAZRNA 1 205 4 1 513 7 8 896 d n lla bs 2DNAZRNA 268 7 279 8 394 0 439 8 10 7 E pene b b E E E b 4
121. ls Guidance Document Drug Metabol izing Enzyme Genotyping Systen 6 FDA 2005 3 10H 48 Rx Guidance for Industry and FDA Staff Class Special Controls Guidance Document Instrumentation for Clinical Multiplex Test Systens 7 FDA CIR 2005 10 26 A Guidance for Industry and FDA Staff Class Special Controls Guidance Document CFTR Gene Mutation Detection Systens 8 FDA 2006 2 9 Draft Guidance for Industry and FDA Staff Pharmacogenetic Tests and Genetic Tests for Heritable Markers 9 NATURE BIOTECHNOLOGY Vol 24 No 9 2006 1039 Making the most of microarrays EDITORIAL 10 NATURE BIOTECHNOLOGY Vol 24 No 9 2006 1103 Daniel A Casciano amp Janet Woodcock Empowering microarrays in the regul
122. ods Biochip Clontech Takara Bio Device Biochips reagents equipment consumables 54 2 23 Biochip Oxford Gene Device Manages the intellectual property Technology of microarray pioneer Edwin Southern Equipment Bio Rad Labs Device Equipment reagents used in DNA 45 lian ape bea Biochip CombiMatrix Device Software controlled fluidic based 31 biochip method for benchtop production reagents content equipment Biochip Panomics Device Molecular biology methods to 26 make biochips reagent development i 23 3 3 Biochip NimbleGen Device Optical array design reagents scanning Agilent Tech LSCA Biochips reagents equipment Biochip Telechem International Device Biochips reagents consumable Biochip Oxford Gene Device Manages the intellectual property Technology of microarray pioneer Edwin Southern Array it scanner design arrayers Spotfire Inc Analytical software methods 8 Source Public company documents European Patent Office Takeda Pacific assessments amp 2005 Molecular Diagnostics 155 6 Biosecurity 42 4 Personal Identity 42 4 Agriculture 14 1 Environmental 14 1 Source Takeda Pacific Estimates 55 3 31 2 DN A WG 3 2
123. t CYP2D6 PM EM CYP2D6 Fluoxetine P450 2D6 PM 5 Fluoxetine CYP2D6 3 Fluoxetine HCL Fluoxetine HCL and Olanzapine mi3 Cevimeline hydrochloridelm14 Tolterodine m15 Terbinafine m16 Tramadol Acetamophen mi7 Clozapinelm18 Aripiprazole Im19 Metoprolol m20 Propranolol m21 Carvedi lol m22 Propafenone m23 Thior idazine m24 Protriptyline HCI m25 PDMed ID 16472103 16384813 15063083 16271013 16236141 15828850 15492763 15037866 14639062 10431214 1302039 DPD Deficiency DP
124. tion 4 10wg and Labeling System Pak CDNA OM cDNA OAR DM aRNA RW RNA total RM total RW 42 DNA RM RA RW cDNA O Dye cDNA
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