平成23年度経済産業省委託事業 平成23年度戦略的技術開発委託費
Contents
1.2.
3.
4. 4
5. FDA
6. RNA
7. MAQC II
8. 6 7 5 8 5 10 k
9. 32 3
10. SPIDIA SPIDIA 3
11. http www fda gov cdrh modact leastburdensome html 2 ai FDA
12. i ii iii
13. DNA 4 18 FE
14. Web
15. SPIDIA 4 13 9 CEN DNA RNA
16. HS time to event
17. 7
18. CONFIDENTIAL JMAC 2007 2012 All Rights Reserved 28 n m
19. 6
20. OK
21. 4 1 1 E
22. validation GMO 4 1 9 2 4 1 10 3 160 4 1 11
23. 28
24. x 5 7 HE Sargent DJ Conley BA Allegra C Collette L Clinical trial designs for predictive marker validation in cancer treatment trials J Clin Oncol 2005 23 9 2020 2027 2 Class II Special Controls Guidance Document Instrumentation for Clinical Multiplex Test Systems 3 Class II Special Controls Guidance Document Instrumentation for Clinical Multiplex Test Systems 37 4Five years is u
25. SEER FIR SOP QC QC RNA
26. FDA FFPE 34
27. RNA FDA 2 RNA RNA 2 MAQC 2
28. 144 2 4 2 4 1 Reflection paper on methodological issues associated with pharmacogenomic biomarkers in relation to clinical development and patient selection 2 4 2 EMA 2 4 3 2011 3 EMA
29. 2 65 25C 7 2 8 4 2 1
30. RT PCR
31. FDA
32. re 9 ii e e 0 e JIS ISO SEJAS ol 9 os Do AT rr 89 1 2 DNA 3 3 1 DNA 3 2 23 DNA
33. 181 JMAC
34. 4 1 12 4 1 13
35. ICH EU JCCLS DNA RNA
36. RT PCR
37. Fe
38. 5 92 5 60 6 10 k 29
39. 36 Hn ul
40. CLSI CLSI EPS A CLSI EP12 A 31 BUA
41. 1 5 3 2 3 2 1 1 1 23 11 16 DNA DNA FDA RT PCR IVDMIA PGx DNA DNA
42. A
43. SPIDIA 70 2011 BRN 2011 3 28 29 _Uwe Oelmiiler EU SPIDIA in vitro _Sibylle Gidisch _Daniel Griz PAXgene http www brnsymposium com 7 2011 4 29 30
44. RNA RNA 18S 28S RNA 1
45. 3 RT PCR
46. Du 158 4 1 1 DNA DNAN DNA
47. 2011 6 13 17 qPCR SPIDIA SPIDIA SPIDIA SPIDIA SPIDIA Standardisation and improvement of generic pre analytical tools and procedures for in vitro diagnostics in vitro 4 SPIDIA
48. D DNA DNA
49. SPIDIA 3 2 5 SPIDIA PFPE PAXgene fixed and paraffin embedded PAXgene
50. ar x Be BA HT 1 H18 2007 amp Fuji Keizai USA DNA RNA 2006 25 2010 40 15 80 1217 2011 BBC DNA 47 5 2011 THY BRA DNA
51. FDA 21 CFR 58 CMS CLIA CLIA CLIA V
52. RNA RNA MHA BR RRA
53. VIL gt II IV A CDISC CDISC SDTM SEND SDTM http www cdisc org B
54. MAQC II MAQC II 150
55. DNA 182 2 3 2 3 DNA 100 8901 1 3 1 TEL 03 3501 1562 FAX 03 3501 0315 URL http www meti go jp T 305 8564 1 1 1
56. 2 3 4 2003 National Human Genome Research Institute 1 000 2 3 4 3 1 DNA DNA 4
57. RRACHHTORTCHODED 4 2 Global Biochip Markets Microarrays and Lab on a Chip BCC Research 2011 8 4 ARRAYIT CORPORATION Dr Mark Schena Ph D
58. sensitivity FRE 145 specificity HER 2
59. OD QA QC QC ERCC RNA MAQC DNA RNA CHS 12
60. DNA MAQC Web
61. 143 false negative
62. 2
63. GSTF 15 DNA FDA II validation GSTF
64. IHC BIOCARTIS POCT Point of care testing 1 4 2 5 AGENDIA BV Science Park 406 1098 XH Amsterdam The Netherlands Tel 31 20 462 1500 Fax 31 6 123 50044 Website www agendia com 2007
65. MAQC II 13 6 mature RALI MAQC II
66. 1 1 MAQC I 1
67. 5 DNA DNA RNA 2 4
68. NGS JMAC 4 2 3 PATHWORK DIAGNOSIS Dr David Craford Chief Commercial Officer 2012 02 10 2008 Tissue of Origin FDA IVDMIA 15 2010 FDA 2010 Redwood City CA 94063 164
69. 3 5 3 6 DNA 108 3 1 DNA
70. 510 k II
71. DNA 3 3 3 4
72. 1 CEL Affymetrix GeneChip ID GenBank ID 1 1 ID GenBank ID 1 ID p
73. space MAQC 1II MAQC II 149
74. 7
75. Q PTR RT PCR 48 I A Hl
76. RNA Afymetrix 4 RNA RNA 67 D RNA RNA EDTA RNA
77. _ 54 _ Lowess _ I ExpSumTable MIAME C CDISC SEND SDTM
78. PAXgene PAXgene OIVDMIA DX OFDA FDA LDT FDA Breast Cancer OFDA
79. 1 P 5 2 P 5 1 2 95 5
80. ER FDA
81. GMP LDT DNA CONFIDENTIAL JMAC 2007 2012 All Rights Reserved 122 27 m
82. DNA DNA e Loni i 1 0404002 20 4 4 http www meti go jp policy mono_ he Lend info_service service iryou_fukushi index html 2 0118 1 22 1 18 4 pate 3 0528 1 22 05 28 JMAC 68 19 10 2AB AMARIA h 4
83. RNA RNA RNA RNA
84. 3 77 DNA 1 3
85. O ICH FDA vs CLIA O FDA CLIA LDT O JCCLS DNA CONFIDENTIAL 40 JMAC 2007 2012 All Rights Reserved 129 JMAC Japan MicroArray Consortium CONFIDENTIAL 41 JMAC 2007 2012 All Rights Reserved 130 3 2 2 3 DNA
86. DNA E validation GMO CONFIDENTIAL JMAC 2007 2012 All Rights Reserved 26
87. DNA 3 2 1 1 PSS 3 2 1 2 DNA chip 3 2 1 3 DNA 1 JMAC 3 3 DNA
88. E CONFIDENTIAL JMAC 2007 2012 All Rights Reserved 123 29 SPIDIA SPIDIA Dr Uwe Oelmuller SPIDIA 4 2008 2012 6 7 8 1 300 EC 900 1 2 3
89. 48 1 DNA
90. SPIDIA 3 2 4 SPIDIA SPIDIA 3 RING TRIAL DNA RNA
91. MAQC II SPIDIA O MAQC I DNA MAQC DNA DNA MIAME MG FGD
92. FDA HIPAA Hhttp aspe os dhhs gov admnsimp
93. D NA MammaPrint Agendia WEEMS 9NA ea 70 Es ii tak amp SA Rp 3 te OWA 2 a1 a 3 Ce a X Na sua g 1 2 3 rna x wo HAMEMADE REL BEBOGROANCE et RNA 5DNA ONA RUR Y ONAOD RNA ee Sy OS RNA OT Ln 2 DNA SUR HAMEED B TUNENS D N A 2007 6 15 AS
94. RNA RNA RNase RNase RNA RNA RNase RNA RNA RNA RNA RNA
95. SPIDIA SPIDIA 3 in vitro DNA RNA in vitro
96. 1300 2 7 2 8 C 8 PAXgene PAXgene DNA mi RNA PAXgene RNA
97. 1
98. 3 2 EU SPIDIA 3 2 1 SPIDIA SPIDIA Dr Uwe 0elmuller SPIDIA Dr Oelmul ler Vice President R amp D SPIDIA Dr Oelmuller Dr Uwe Oelmuller Vice President R amp D QIAGEN Dr Ralf Wyrich Senior Scientist R amp D QIAGEN Dr Daniel Grolz Scientific Associate Director R amp D QIAGEN SPIDIA
99. IVDMIA MammaPrint Pathwork AlloMap Ovarian Cancer Testing 4 IVDMIA FDA LDT LDT FDA CMS FDA ISO GMO CD 10 TC SPIDIA 7 8 2008 2012
100. LDT V FDA LDT v FDA 1 3 FDA FDA 3 LDT 147 FDA LDT Agendia FDA 70 IVDMIA
101. 1 2 5 10 3 102 SPIDIA Newsletter SPTD1A 10 2011 6 8 SPIDIA Standardisation and improvement of generic pre analytical tools and procedures for in vitro diagnostics OI 4 2009 2012 1300 EC 900 7 8
102. 3 103 SPIDIA Newsletter SPIDIA 10 2011 6 8 PAXgene Tissue System CD2 CD3 ERa PR Her2 cytokeratin 7 Ki67 S100 vimentin 30 219 322 DNA RNA PAXgene Blood RNA RNA SPIDIA
103. MER 3
104. SPIDIA kia a SPIDIA Newsletter SPTD1A 10 2011 6 8 SPIDTA 3 1 DNA RNA or
105. 2 1 2 4 7 aaa verification
106. DNA 100 MicroArray Quality Control MAQC Project http www fda gov FDA 51 MAQC 1300 DNA DNA Phase I DNA 2005 2 2006 9 Nature Biotechnology 2006 9 Phase II 2006 9 2009 3 Nature Biotechnology 2010 8 Phase III 2008 12 Nature Biotechnology MAOQC II 28 pp810 812 News and Views DNA MAQC I MAQC II geese Classifier
107. 4 1 JMAC 14 ST TOO OO OSC Q O D D DIA DNA
108. Ol 30 24 Federal Register
109. T FDA 21 510K IVDMIA 2 3 IVDMIA
110. IND NDA BLA FDA FDA 2003 3 FDA FDA
111. 51 FDA RAEE oT WERIT
112. BASE BRA g ee eeeeeeeee o 3 ht Sa 96 2 DNA 1 97 23 DNA 1 23 11 16 DNA 3 DNA
113. 4 5 ADME 6 B
114. 2 2 1 3 17 DNA
115. WG 2010 SPIDIA 11 1 2010 MER 2010
116. 17 Halcyon Molecular TEM 1000 250 Helicos Genetic Analysis System Helicos Single Molecule Sequencer 1 Vertual Terminator 32 174 Intelligent Bio Max Seq Genome 4 0 Nucleotide reversible Systems Sequencer terminators Intelligent Bio SystemsSequencing By Synthesis Intelligent Bio Systems SBS 2 8 16
117. FDA should 40 I IND NDA BLA A RNA RNA 1 RNA
118. 2 DNA DNA T OF MS HPLC 3 OD260 260 nm 84 4 2 3 CDC Genetic Testing Reference Material Coordination Program
119. CTD 1 CTD 1 2 CTD 2 j 3 CTD 3 4 E CTD 4 5 CTD 5 CONFIDENTIAL JMAC 2007 2012 All Rights Reserved 116 1 2 0 0 0
120. SDTM CDISC SEND MWEE ll WESI EXPSUMTABLE ExpSumTable 3 1 2 ID ID ID 3 ExpSumTable
121. SPIDIA European Research Infrastructure BBBMRI Biobanking and Biomolecular Resources Research Infrastructure www bbmri cu SPIDIA CLSI Clinical and Laboratory Standards Institute www clsi org OBBR Office of Biorepositories and Biospecimen Research www biospecimens cancer gov caHUB cancer Human Biobank NIH GTEx Genotype Tissue Expression www commonfund nih gov gtex BRN Biospecimen Research Network 2011 6 13 17 qPCR SPIDIA 2011 6 13 17 qPCR PCR http www qpersymposium eu SPIDIA TA
122. MER 3 1 2 2 WG 1 24 1 12 A 15 00 17 00 2 4 LARE 3 Se BS 4 1 1 WG 2 PSS 3 2007 4 2010 4 1 2010
123. V amp V 10 k FDA FDA FDA http www fda gov cdrh ode 510kmod pdf 35 FDA http www fda gov cdrh ode guidance 585 pdf 21 CFR 820 30 Subpart C
124. 4 FDA FDA 4 4 1
125. FDA PMA 510k 141 5 Appendix
126. 3 1 3 3 WG 1 24 2 23 A 15 00 17 00 D 20 L 3 4 1 2 WG 2 DNA chip 3 IMAC DNA 4 2010 2010 5 1
127. TEL FAX 029 861 7840 E Mail human ws m aist go jp
128. DNA 4 MAQC 0 MAQC I DNA Lt MAQC I Classifier 6 13 6 Affymetrix Amersham Agilent DNA SPIDIA SPIDIA
129. 2 2 1 1 DNA RNA 2 DNA DNA Tm melting temperature GC PNA LNA 78 2 2 1 RNA RNA
130. MAQC II 5 10
131. SPIDIA SPIDIA 2008 2012 4 1 300 7 8 SPIDIA RNA PAXgene Tissue System 30 AHO 219 322 PAXgene Blood RNA QIAGEN
132. TEL FAX 029 861 7840 E Mail human ws m aist go jp The guideline in English has been prepared for providing information abroad and handling inquiries from foreign countries For more information please contact The Secretariat of R amp D Guideline for Medical Device Secretariat TEL FAX 029 861 7840 E Mail human ws m aist go jp 86 6 23 2006 400 JCCLS
133. ZMW DNA DNA SMRT 2 10 1 RNAP RNA RNAP RNA DNA RNAP 1
134. DNA WG 1 WG 23 11 16 2 WG 24 1 12 A 3 WG 24 2 23 A 1 1 2 2 DiS Do ol Dow 2 O a Sir aE E T bc Sa E EE rE Pe 2 2 3 4 3 DAFO AORE E i n a a A EE EE 6 ZI RAFS AOAR E ea a a a 6 3 W eh 6 3 1 2 2 WG i 10 3 1 3 3 OAA WO 13 E 2 r E A E E EA EAEE EES 17 EEE ee A D E OE EAE E E EE EN E OEE EEEE E 17 GD De Mee tre O annn en n aS 18 3235 RERE DE AO E NN NN NN 19 ge e E n r tac A 21 3 4 DNA eccecceeeeeeceeeeneeseeeneeeneeseeeneeseeneenneeees 23 3 4 1 FDA 1 23 3 4 2 FDA 2
135. GBM Predictive GBMs Prognostic GBMs single marker multimarker signature outside of scope 3 4 DNA RNA
136. IEC 62304 2006 2 DNA 2 6 ID DNA 2 7 1 DNA DNA DNA
137. DNA 5 1 1 2 3 4 DNA DNA DNA DNA 1 DNA1 DNA DNA 1 Post light 1 25 Gb day gt 100 Mb run hr Ion Torrent Systems 2000 1 695 000 Pac 45 000
138. 4000 5000 CLIA CAP MMWR FDA JMAC qPCR NGS FFPE JMAC 2014 KRAS
139. 1 DNA 1000 6 DNA F DNA C PCR C IL 28B AND rs8099917 we 2b B HBs
140. FDA SPIDIA 3 4 DNA DNA 13 5 DNA DNA F 2010 R 4 24
141. ee E E E pe JMAC JCCLS 22 3 4 DNA 3 4 1 FDA 1 1 23 11 16 FDA 22 TI 2007 4 9 1 Class II Special Controls Gene Expression Profiling Test System for Breast Cancer Prognosis May 9 2007 II 2007 5 9
142. PCR 8 cross linking RNA 72 RNA 5 LAL MicroRNA MicroRNA f Clustering 8 3 1 4 1 RNA 30 904 MicroRNA 63
143. DNA 2 8 Heliscope 1 1 polyA DNA extension 1 1 C 1 55 RNA 2 9 SMRT MRT DNA ZMWs
144. CEN ISO 5 RNA FDA FDA MAQC SOLID Roche 454 FEDA
145. 4 1 16 161
146. 10 k RNA RNA OD260 OD280 RNA 28S 18S RNA RUO 1 2 RNA 3 3 RNA
147. FDA 27
148. 83 4 2 1 1 AEAEE EATE AANEREN S IEA T EONA 2
149. DNA DNA F 4 1 2 1 4 1 1 4 1 3 DNA 2000 4 1 4 1
150. 4 in vitro in vivo BERETS CL 5 2 3 2 3 1 Draft Guidance for Industry and Food and Drug Administration Staff Factors to Consider when Making Benefit Risk Determinations in Medical Device Premarket Review 2 3 2 Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research 2 3 3 FDA
151. CONFIDENTIAL 38 JMAC 2007 2012 All Rights Reserved 128 Gene Analyzer lx BG 7 770 CRA 5 HiSeq1000 2000 1 540 600Gb 30x 2x 150bp 27 1 5 2 0Gb SOLiID SOLiD5500xl 1 20 30Gb DNA 1 2 eS di hahaa To ES y aa gpl RR A H18 454 5 asa 1 000 000 23 3 NIANZIE 1Gb 500 700 200bp e DNA nanoball DNA
152. 2011 178 CCR4 DT ATL 2011 4 2 4 PR MAGE A3 m2000 KRAS 2011 8 EGFR 2009 5 Rindopepimut EGFR EGFRv III RNA 2010 2 HER2 neu 4B5 INFORM DM1 HER2 Dual ISH DNA Probe Cocktail HER2 neu 4B5
153. DNA 1 RNA 1
154. 4 SPIDIA 7 8 CEN SPIDIA 1300 13 EC 900 9 3 2 3 154
155. 46 5 6 E
156. 12 DNA RNA DNA 3 3 RNA WG LDT 1 2 3
157. IVD EBT LDT 136 FDA 3 IVD 4 IVD 3 IVD IVD
158. RNA cDNA DNA R N A 4 2 2 1 DNA HP LC
159. O MAQC II SPIDIA O SPIDIA
160. E 2 2 3 1 DNA DNA
161. IVD IVD FDA IVD IVD IVD 510k FDA IVD FDA
162. 2 1 2 8 2 4
163. 3 109 DNA JMAC CONFIDENTIAL JMAC 2007 2012 All Rights Reserved nae He iHe RPAH ORME IMI RUM ICIS SIR f H19 RGF SARA RH OMA MT SONATA JBA CONFIVENTIAL 12 JMAC 2007 2012 All Rights Reserved 110 SPIDIA 2008 MAQC and Il 2005 RT PCR 2005 Class II Special Controls Guidance Document RNA Preanalytical Systems RNA Collection Stabilization and Purification Systems for RT PCR used in Molecular Diagnostic Testing lt gt Draft Guidance for Industry Clinical Laboratori dFDA WA 2007 Vitro Diagnostic Multivariate Index Assays NDMA lt gt Class II Special Controls Guid Do t Gene EX i 2 2007 profing Test
164. RNA RNA RNA RNA
165. qPCR in vitro SPIDIA
166. 10 RNA MicroRNA 20 MicroRNA RNA MicroRNA ORA DNA O3D Gene 100 3 3 DNA
167. oR FDA IVD a IW FDA FDA LDT Laboratory Developed Test FDA 3
168. FDA SPIDIA DNA DNA 2011 R JIS ISO DNA
169. RNA 30 RNA
170. f JIS EE 22325 RE mg it 7s em WG WG 93 WG METIS NEDO WG WG 13 WG 17 22
171. 2010 Royal Philips Electronics 2012 PCR DNA RNA DNA 165 Biocartis 4tlk Philips 2010 11 bioMerieux Biocartis 2012 2013
172. 3 8 4 4 1 DN A 4 2 DNA
173. SPIDIA SPIDIA SPIDIA SPIDIA SPIDIA SPIDIA 1 Ruth Chadwick Cardiff University and Anne Cambon Thompson INSERM PEC PEC OECI TuBaFrost Code
174. 1 21 CFR 807 E 2 3 FDA 3 10 k
175. 310 k FDA should EL
176. ID ID ppk 1 1 GtI_1 Ctl_1 cel 0 2 Ctl_2 CtI_2 cel 0 3 Ctl_3 CtI_3 cel 0 4 GtI_4 CtI_4 cel 0 5 Ctl 5 Ctl_5 cel 0 6 Ctl_6 Ctl_6 cel 0 7 Ctl_7 CtI_7 cel 0 8 Ctl_8 Ctl_8 cel 0 9 CtI_9 CtI_9 cel 0 10 CtI_10 CtI_10 cel 0 11 CtI_11 CtI_11 cel 0 12 Treat_1 Treat_1 cel 10 1 13 Treat_2 Treat_2 cel 50 1 14 Treat_3 Treat_3 cel 100 1 15 Treat_4 Treat_4 cel 10 2 16 Treat_5 Treat_5 cel 50 2 17 Treat_6 Treat_6 cel 100 2 18 Treat_7 Treat_7 cel 10 3 19 Treat_8 Treat_8 cel 50 3 20 Treat_9 Treat_9 cel 100 3 21 Treat_10 Treat_10 cel 10 4 22 Treat_11 Treat_11 cel 50 4 23 Treat_12 Treat_12 cel 100 4
177. PBMC RNA RNA mRNA 6 PBMC RNA RNA 2 4 RNA
178. 2012 PCR DNA RNA DNA Biocartis Philips 2010 11 bioMerieux 170 Biocartis DIAGNOSWISS S A Z Les llettes Secteur 4 CH 1870 MONTHEY Switzerland Tel 41 24 473 7540 Fax 41 24 473 7541 Website www diagnoswiss com diagnoSwiss 1999 ELISA
179. 2012 20 3 4 4 1 1 7 SOLiD 4 Roche454 3 FDA 3 ABRF PacBio RS Ion Torrent PGM
180. 41 RNA BF ait fala 2 RNA RNA RNA RNA
181. Reference DNA 20 Cancer Non cancer 95 RNA 60 clustering clustering 90 2 BH 1 RNA 19 4 20C 1 80 validation
182. 5 107 4 5 2 3 3 3 4
183. RNA 2 5 1
184. 2 o 45 1 QC QC 2 QC RERU QC 1
185. Pima CD4 test 2009 CE Mark HIV BNP MAS BNP ARRAY ON GMBH Am Schwabeplan 1b D 06466 Gatersleben Germany Tel 49 38482 79 9911 Fax 49 39482 7999 23 Website www array on com BIOSCORA Deutscher Platz 5c D 04103 Leipzig Germany Tel 49 341 2222 0310 Fax 49 341 2222 9320 Website www bioscora de 2003 SNPs 168 BOEHRINGER INGELHEIM MICROPARTS GMBH Hauert 7 D 44227 Dortmund Germany Tel 49 231 9799 0 Fax 49 231 9799 100 Website www microparts de 2004 Steag microParts Gm
186. CONFIDENTIAL JMAC 2007 2012 All Rights Reserved 30 SPIDIA DNA DNAplas RNA RING Trial Ring Trial Name What do you What do you What does receive extract SPIDIA evaluate SPIDIA DNA Whole blood Genomic DNA Quality sample Quantity SPIDIA Whole blood Genomic DNA Quality DNAplas sample Quantity sample Cell free DNA Quantity Integrity RNA Whole blood Quality sample Quantity Stability CONFIDENTIAL JMAC 2007 2012 All Rights Reserved 124 RING TRIAL Le Programme DNA Ring DNA Trial DNAplas as SPDIA LAB Ring Trial real time PCR RNase P DNA as SPDIA LAB DNA Isohelix Quality Check Kit MIDNA HEE Agilent DNA Kit DNA Kineret software RNA Ring RNA Trial K2EDTA
187. 131 2 3 DNA 132 Mi CPU 3 3 2 1 IVD a oo ccc eee 5 2 2 10 2 3 12 2 4 ee 16 2 5 ooa 18 18 NE 18 EUSPLDIA shes ewe Cv etat eh de kv nd et de on ed tt be dee ve 26 DNA a araara 32 4 1 32 4 2 37 51 DNA i 59 cd OO 63 133 DIA
188. 1 TII RNA RT PCR RNA
189. DNA mRNA paired mRNA Bz physiological significance exploratory development confirmatory development RCT 6
190. i organization code ii data set code iii endpoint code iv summary and normalization v feature selection method vi number of features used vii classification algorithm viii batch effect removal method ix type of internal validation x number of iterations of internal validation i MCC ii accuracy iii sensitivity iv specificity v AUC vi mean of sensitivity and specificity vii rm s e Nature Biotechnology MAQC I1 HEM 28 pp827 838 6 9 MAQC II 36 13 6 30 000
191. FDA 1 2 3 2 1 time to event 9 5 5
192. HFZ 220 1350 Piccard Drive Rockville MD 20850 4307 U S A http www fda gov cdrh ggpmain html dsma cdrh fda gov Fax 301 443 8818 800 638 2041 301 443 6597 301 827 3993 IL A RNA 1 RNA 2 RNA 3 ERU PBMC RNA 4 RNA 5 RNA QC B C D E F II A B DNA C 39 IV V VI A B C
193. IW 4 IVD REO FDA IVD 4 IVD IVD Act Act 505 351
194. 4 2 11 R DNA DNA 2 12 VisiGen Biotechnologies VisiGen Biotechnologies DNA 177 FRET
195. IVD IVD FDA IVD 138 C IVD IVD FDA IVD IVD
196. SPIDIA 3 SPIDIA http www efcclm eu spidia 2011 10 30 RNA SPIDIA SPIDIA
197. RNA QIAsymphony SP QIAGEN miRNA RNA miRNA RNA RNA RT PCR QIAsymphony AS QIAGEN
198. QIAGEN Spoorstraat 50 Venlo 511 KJ The Netherlands Tel 31 77 320 8400 Fax 31 77 320 8409 Website www giagen com DNA RNA 2007 Digene 2009 DxS RT PCR 7 DxS TheraScreen KRAS mutation kit EGFR KRAS CE Mark FDA DxS QIAsymphony Rotor Gene 167 SKYLINE DIAGNOSTICS B V Dr Molewaterplein 50 Ste Ee1971 3015 GE Rotterdam The Nether lands Tel 31 10 703 8410 Fax 31 10 704 3076 Website www skyline diagnostics nl AMLProfiler AML 2009 CE mark 2011 FDA Affymetrix ALERE TECHNOLOGIES GMBH Loebstedter Str 103 105 D 07749 Jena Germany Tel 49 3641 3111 0 Fax 49 3641 3111 120 Website www alere technologies com Epocal
199. RNA 1 4 DNA MammaPrint DNA RNA RT PCR Oncotype DX 1 DNA DNA DNA
200. x CHS 33 10 k 5
201. SEQC 5 FDA 1 2 3 BGI 500 4 5
202. CDNA CONFIDENTIAL JMAC 2007 2012 All Rights Reserved 127 MAQC SEQC N Sequencing Quality Control 2008 2011 Association of Biomolecular of Resource Facilities ABRF FDA 2012 5 1 2 3 BGI 4 5 CONFIDENTIAL 37 JMAC 2007 2012 All Rights Reserved SEQC 1 1 JMAC Coraormum EE SOLID Roche 454
203. 15 16 17 18 CONFIDENTIAL JMAC 2007 2012 All Rights Reserved 22 DNA
204. 2008 2012 9 4 6 SPIDIA CEN European Committee for Standardization 180 DIS Drafted International Standard CEN IS0 153 CEN
205. NIH CLSI Clinical and Laboratory Standards Institute SPIDIA FDA SPIDIA PFPE PAXgene fixed and paraffin embedded Kap M Smedts et al Histological Assessment of PAXgene Tissue Fixation and Stabilization Reagents PLOS ONE 2011 6 11 RING TRIAL DNA RNA DNA
206. m BD PreAnalytiX PAXgene BD QIAGEN PreAnalytX BD 104 DNA WG E Zz JCCLS 1 2 2 WG 3 2 2 1 0 4 2 2 1 1 2 9 2 3 2 1 4
207. ICH CTD CTD 140 1 2 0 0 0 3
208. SEND 11 http www cdisc org models send v2 3 SENDV2 3ImplementationGuide pdf 10 S X 6 1 6 SEND ER 2 56 1 WAREZ I SSPARMC SSSE D SSPAR SSVAL Q STTYP 1 LBNAM XYZ 2 LBLOC 3 SPECIES 4 STRAIN Sprague Dawley 5 DESIGN
209. 23 DNA DNA FDA 7 FDA 8 FDA 3 CLIA FDA JCCLS OECD CLIA 7
210. HHC FISH Daco Monogram Trofile CYP2D6 2 5
211. SPIDIA 2 QIAsymphony SP QIAGEN RNA PAXgene Blood RNA System PreAnalytix PreAnalytix BD QIAGEN BD QIAGEN 3 2007
212. FFPE EU SPIDIA PAXgene LT PFPE PAXgene LTY CEN ISO
213. mCRC 2 Bernini P Bertini I Luchinat C Nincheri P Staderini S Turano P Standard operating procedures for pre analytical handling of blood and urine for metabolomic studies and biobanks J Biomol NMR 2011 Apr 49 3 4 231 43 Bertini I Cacciatore S Jensen BV Schou JV Johansen JS Kruh Y ffer M Luchinat C Nielsen DL Turano P Metabolomic NMR fingerprinting to identify and predict survival of patients with metastatic colorectal cancer SPIDIA SPIDIA CEN European Committee for Standardization in Brussels in vitro
214. 2 1 DNA R2 1 FEE 2 2 SPIDIA 2008 MAQC I and II 2005 RT PCR 2005 Class II Special Controls Guidance Document RNA Preanalytical Systems RNA Col lection Stabilization and Purification Systems for RT PCR used in Molecular Diagnostic Testing IVDMIA 2007 Draft Guidance for Industry Clinical Laboratories and FDA In Vitro Diagnostic Multivariate Index Assays IVDMIA 2007 Class II Special Controls Guidance Document Gene Expression Profiling Test System for Breast Cancer Prognosis 2007 PGx 2007 2009 Good Labor
215. T SS T ocot e000 eee ee6 O ik ee oeee eeee 8 B 1 total RNA RNA cDNA DNA DNA 2 8 log 4 B 73 a RNA MCF 7 17B estradiol E2 10 nM
216. PacBio RS 1 SMRT by Polonator GO07 M 1 TAKN f F 2 1000 250 TEM NG Helicos Genetic 1 Analysis System Helicos Single Molecule Vertual Es quencer CONFIDENTIAL 39 JMAC 2007 2012 All Rights Reserved FDA
217. FDA CE IW CE IVD LIST A LIST B CE FDA PAXgene FDA510k RT PCR Affimetrix Agilent Illumina DNA FDA510k QIACUBE QIACymphony FDA SPIDIA 2012 9 2013 3 3 2 2 SPIDIA SPIDIA
218. IVD PMA 510k 139 2 2 2 2 1 Guidance for Industry E16 Biomarkers Related to Drug or Biotechnology Product Development Context Structure and Format of Qualification Submissions 2 2 2 ICH EU 2 2 3 ICH EU 1 20 PMDA http www pmda go jp ich e e16_11_1_20 pdf
219. JMAC Arrayit RNA Arrayit Arrayit 2 FDA 4 2 2 PHALANX BIO Dr Lester Lien President US Office
220. LDT AdvaMed CLIA FDA FDA FDA CMS 6 FDA CMS ao A O N AdvaMed FDA FDA CLIA
221. http www mdanderson org education and research education and training schools and programs cme conference management conferences cme conference management reverse phase protein array global workshop html 53 2011 10 12 15 _Sibylle Gidisch PAXgene http www helmholtz muenchen de histochemistry2011 ESBB 2011 11 16 19 _Uwe Oelmiiler EU SPIDIA http www esbb org nov2011 3 SPIDIA 2011 4 SPIDIA SPIDIA QIAGEN GmbH QIAGEN 1 40724 KineretTM Labonnet Ltd Agilent 4 Agilent Corporation Isohelix 1 Cell Projects Ltd Affymetrix 4 Affymetrix Inc 72 3 5 DNA 3 5 1 205
222. 1 DNA 1 SOLiID 5 2 4 Solexa DNA 4 RT bases DNA 1 3 DNA ADs 5 2 5 SOLID
223. DNA PFDA NimbleGen 2010 CapitalBio NimbleGen 2010 DNA IBM IBM NIH 454 Life Sciences 2010 Roche Applied Sciences Exiqon Roche Exidon miRCURY LNA Universal RT microRna gPCR system Exiqon FFPE
224. Affymetrix DNA DNA CONFIDENTIAL JMAC 2007 2012 All Rights Reserved 120 23 lt GMP
225. DNA 1 87 PCR SAGE DNA DNA DNA DNA FY FICK SBE 3 DNA DNA
226. DNA OR mRNA DNA B DNA DNA EDTA CPD ACD DNA DNA DNA DNA
227. Department of Pathology Josephine Nefkens Institute Erasmus MC Rotterdam EMC Institute of Pathology Medical University of Graz MUG Institute of Pathology Technical University Munich TUM 64 3500 PAXgene HE 40 CD2 CD3 CD5 CD10 ERo PR Her2 5 6 AE1
228. PCR RNase P DNA SPIDIA QIAGEN GmbH DNA Isohelix Quality Check Agilent 1 DNA DNA DNA KineretTM Version 1 0 5 Labonnet Ltd KD SPIDIA RNA DNA SPIDIA RNA RNA
229. 3 2 5 4 5mm DNA DNA MicroRNA MicroRNA MicroRNA 3D Gene RT PCR
230. DNA DNA DNA RNA DNA DNA
231. FDA IVD FDA FDA 137 A IVD IVD IVD FDA IVD IVD
232. 14 c 1 B FDA http www fda gov cdrh ode guidance 1131 pdf 310 k 310 k http www fda gov cdrh devadvice 3144 html 3 21 CFR 866 6040 NYI 21 CFR 866 6040 RNA
233. PCR DNA RNA DNA 2012 2013 Philips bioMerieux FDA BIOCARTIS SA CS Scientific Parc EPFL PSE C s CH 1015 Lausanne Switzerland CARTIS Website www biocartis com CONFIDENTIAL 35 JMAC 2007 2012 All Rights Reserved 36 LDT FDA FDA RNA qPCR DNA FFPE FBS
234. DNA RER validation Affymetrix Agilent Affymetrix Agilent
235. 6 On Off DNA 4 1 8 9 DNA
236. 18S 28S RNA RNA 28S 18S 2 RNA 2 RNA 18S 28S rRNA 28S 18S rRNA RNA 5 RNA RNA RNA RNA RNA RNA DNA B
237. 19 DNA TS DNA DNA IVDMIA 21 DNA 22
238. 510k PMA Premarket Approval LDT AE LDT ee FDA IVD FDA 2011 7 FDA LDT IVD FDA IVD v LDT
239. 2 5 1 2 5 2 JCCLS 2 5 3 DNA RNA 3 3 1 FDA MAQC 3 1 1 IVDMIA FDA IVDMIA 2006 2007 2 146 CD 3 FDA LDT Laboratory Developed Tests amp IVD
240. 2007 2 CLIA CLIA 21 FDA Genomic Health FDA FDA FDA LDT FDA LDT NIH FDA LDT IVD CMS CMS
241. 4 1 m 1 6 C 53
242. DNA DNA 2007 FDA MAQC a DNA DNA DNA 2007 2 FDA 3 WG DNA F DN A 2011
243. DNA 18 19 21 19 DNA 19 TS sxSPIDIA 2008 MAQC I and II 2005 RT PCR 2005 Class II Special Controls Guidance Document RNA Preanalytical Systems RNA Collection Stabilization and Purification Systems for RT PCR used in Molecular Diagnostic Testing eIVDMIA 2007 Draft Guidance for Industry Clinical Laboratories and FDA In Vitro Diagnostic Multivariate Index Assays IVDMIA SL DNA eA 2007 Class II Special Controls Guidance Document Gene Expression Profiling Test System for Breast Cancer Prognosis 2007 PGx 2007 lt 2009 Good Laboratory Practices for Molecular Genetic Testing for GLP Heritab
244. mRNA DNA microRNA MAQC II good model ing practice 3 1 3 FDA MAQC III FDA MAQC III SEQC Sequencing Quality Control MAQC Microarray Quality Control 2005 2008
245. ISO 14971 1 1 AAMI SW68 2001 9 21 CFR 807 87 ec 310 k 21 CFR 809 10 FDA 510 k http www accessdata fda gov 510 k
246. 2008 2012 4 1 300 7 SPIDIA RNA PAXgenc Tissue System 30 219 322 PAXgene Blood RNA QIAGEN
247. ChIP MeDIP ChIP 3 2 3 3 3 24 2 23 DNA chip DNA chip 2003 5 36 10 25 1999 25 35 3 6 Artificial Neural Net
248. MammaPrint Pathwork Tissue of Orgin AlloMap 3 DX MammaPrint FDA CLIA LDT 3
249. 2011 Guidance for Industry FDA 8 10 E16 Biomarkers Related to Drug or Biotechnology Product Development Context Structure and Format of Qualification Submissions 2011 Draft Guidance for Industry and FDA 8 15 Food and Drug Administration Staff Factors to Consider when Making Benefit Risk Determinations in Medical Device Premarket Review 2011 Reflection paper on methodological EMA 7 12 issues associated with pharmacogenomic biomarkers in relation to clinical development and patient selection AA ICH E16 23 FDA 2011 8 10 PMDA 1 20
250. mRNA mRNA PBMC RNA RNA 1 PBMC Ficoll Hypaque
251. 2011 Association of Biomolecular of Resource Facilities ABRF FDA 1 1 3 151 3 SEQC BGI SOLiD SedWright Roche 454 Roche 454 SedWright RNA seq Roche 454 Illumina Life Technology SOLID 3 2012 RNA MAQC 2011
252. Tzs 28 log 74 OH HO Enterodiol O H CO o HO OCH OH Enterolactone Matairesinol HO OH oH o _O Oo o 0 HO 0 OH Pinoresinol Lariciresinol HO CH O H C O OH OH Isolariciresinol Secoisolariciresinol 3 DNA 2 130 log 3 5 3 enterodiol enterolactone matairesinol pinoresinol lariciresinol isolariciresinol secoisolariciresinol
253. SPIDIA 2 QIAsymphony SP QIAGEN RNA PAXgene Blood RNA System PreAnalytix PreAnalytix BD QIAGEN BD QIAGEN QIAGEN 3 2007
254. k MAQC II Genome Wide Association Working Group MAQC II MAQC II MAQC II MAQC II
255. 2 22 5 2 2 22 3 5 4 2 22 5 5 IEC 62304 2006 5 2010 2 3 A
256. 7 SPIDIA 13 000 000 EC 9 000 000 SPIDIA 63 in vitro SPIDIA
257. SAK Agilenttt GAPDH IL1 beta c fos qPCR Kineret RNA RNA RNA RNA QIAsymphony SP QIAGEN RNA RT PCR PAXgene Blood RNA System PAXgene Blood RNA
258. AdvaMed 4 0 3 FDA FDA CAP FDA CLSI CDC CAP 2010 8 15 2011 8 FDA Factors to Consider when Making Benefit Risk Determinations in Me
259. CLIA LDT FDA LDT FDA FDA validation
260. RNA FDA 2007 7 in vitro De 380 000 2 DiVOMIAR EES z Pathwork Diagnostics CO GeneChip GCS 3000Dx LARRA 22 1 DNA DNA 2 GMP DNA
261. 69 Marcel Kap Claudio Orlando RNA Ales Tichopad qPCR Mikael Kubista SPIDIA 2011 6 13 qPCR SPIDIA DNA DNAplas RNA SPIDIA 3 SPIDIA SPIDIA RNA DNA DNAplas Agilent RIN
262. DNA CONFIDENTIAL JMAC 2007 2012 All Rights Reserved 24 On Off DNA CONFIDENTIAL JMAC 2007 2012 All Rights Reserved 121 25
263. SE tb hale IVD BAIAR 2011 7 12 23 1 20 23 12 ICHE16 CONFIDENTIAL JMAC 2007 2012 All Rights Reserved 2007 OECD OECD 2009 GLP CLIA CONFIDENTIAL JMAC 2007 2012 All Rights Reserved 112 Draft Guidance for Industry and Food and Drug Administration Staff In Vitro Companion Diagnostic Devices DRAFT GUIDANCE This guidance document is being distributed for comment purposes only Document issued on July 14 2011 2011 7 14 2011 9 10 60 CDRH CBER CDER B IED on device exemp
264. K Z 9 CONFIDENTIAL JMAC 2007 2012 All Rights Reserved IVD FDA CONFIDENTIAL JMAC 2007 2012 All Rights Reserved 114 Guidance for Industry E16 Biomarkers Related to Drug or Biotechnology ICH International Conference on Harmonisation of Technical P Requirements for Registration roduct Development Coutert Setire and of Pharmaceuticals for Human Format of Qualification Use Submissions 2011 8 10 ICH EU
265. CLIA less stringent Genomic Health OncoType Path FDA CLIA LDT CE 6 qPCR qPCR
266. DNA Cy3 DNA sesamin enterodiol enterolactone matairesinol pinoresinol lariciresinol isolariciresinol secoisolariciresinol 3 5 2 3 5 2 1 130 8 cDNA 1 11 3 5 2 2 DNA S25 or Ss Y cDNA cDNA DNA
267. 2 3 4 1 5 2 4 6 1 2 7 NMR SPIDIA
268. 2004 16 DNA AmpliChip CYP450 DNA FDA Agendia DNA MammaPrint 2007 19 2 FDA IVDMIA In Vitro Diagnostic Multivariate Index Assay 2 18 at 7 19 3 DNA 2007 DNA DNA DNA DNA DNA
269. _Peter Riegman http Imp upol cz workshop201 1 abstrakta_patologie pdf ISBER 2011 2011 5 15 18 _Marcel Kap PAXgene http www isber org mtgs 2011 IFCC 2011 5 15 19 _Uwe Oelm ler EU SPIDIA in vitro _Kurt Zatloukal _Mario Pazzagli http www berlin2011 org TIDES 2011 2011 5 22 25 _Uwe Oelmiiler http www ibchfesciences com TIDES overview x
270. FDA 21 CFR 807 87 25 10 k FDA http www fda gov cdrh devadvice 314 html 10 FDA 3 510 k 510 k 510 k http www fda gov cdrh ode parad510 html 510 k FDA FDA 310 k 10 k http www fda gov cdrh ode guidance 1567 html
271. IVD B IVUD FDA FDA IW IVD FDA IVD PMA 510k IW
272. aS SMB IVD 3 IVD 1 2 3 3
273. H L L 8 3 MAQC II k 478
274. MAQC DNA FDA DNA EU SPIDIA DNA DNA FDA MAQC DNA DNA 106 DNA 1 MAQC II
275. SPIDIA SPIDIA National Cancer Institute NCI PAXgenc NIH GTEx www commonfund nih gov gtex PAXgene 1 000 http www genome gov Pages About NACHGR September2011AgendaDocs NACHGR_Sep122011_GTExUpdate_Struewin g pdf SPID
276. classifier 13 13 1 oroductive MAQC II
277. 1627 Is A i EY 3 4 5 23 7 8 FDA II FDA FDA FDA FDA
278. 75 bp 1 30 456b 1 3 454 Genome Sequencer FLX 1 000 1 000 000 23 Ion P M 3 16b 500 700 200bp Complete Genomics DNA nanoball DNA PacBio RS 1 SMRT DNA 25kb 2000b Dover Systems Polonator G 007
279. DNA F DNA DNA DNA FDA MAQC EU SPIDIA FDA MAQC EU SPIDIA DNA DNA
280. FDA IVD 1 FDA IVD a IVD IVD 2 FDA IVD FDA
281. CONFIDENTIAL JMAC 2007 2012 All Rights Reserved ICH E16 RH ORRR UT o O RERE MY CHURN OM Lo gt a eee Cul ie see our of t sar a ae 4 ABT ROS B 23 1 20 0120 1 0120 1 CONFIDENTIAL JMAC 2007 2012 All Rights Reserved 115 ICH CTD CONFIDENTIAL JMAC 2007 2012 All Rights Reserved
282. 1 MAQC 1
283. 2 DNA 3 DNA 3 4 79
284. 2012 02 09 2004 99 160 250 Belmont CA 94002 validation 163 FISH FISH DNA KH
285. AYANDA BIOSYSTEMS SA PSE Parc Scientifique Building C EPFL CH 1015 Lausanne Switzerland Tel 41 21 693 8631 Fax 41 21 693 8631 Website www ayanda biosys com Ayanda Biosystems 2001 NucliPrep lab on a chip BARD1 BARD1 EU BIOCARTIS SA Scientific Parc EPFL PSE C CH 1015 Lausanne Switzerland Tel 41 21 693 9051 Fax 41 21 560 4291 Website www biocartis com Biocartis 2010 Royal Philips Electronics
286. FDA IVDMIA CLIA tH Genomic Health OncoType DX KONINKLIJKE PHILIPS ELECTRONICS N V Amstelplein 2 1096 BC Amsterdam The Nether lands 2008 Epigenomics AG DNA 2009 Moxtek 166 Tel 20 597 7777 Fax 31 20 591 7210 Website www philips com 2010 bioMerieux Magnotech LIONIX BV Hallenweg 6 7522 NH Enschede The Netherlands Tel 31 53 489 3827 Fax 31 53 201 1303 Website www ionixbv nl
287. 19 TS DNA 2 DNA DNA DNA DNA MammaPrint MAQC I MAQC 1 DNA MAQC Classifier 6 13 6 Affymetrix Amersham Agilent
288. IVD FDA LDT LDT IV IVD FDA
289. PAXgene as SPDIA LAB by integrity Agilent RIN PCR Kineret software CONFIDENTIAL JMAC 2007 2012 All Rights Reserved 32 ARRAYIT CORPORATION Dr Mark Schena CEO 1993 DNA OvaDx 2010 FDA PMA IVD LDT FDA 524 East Weddell Dr sss Arrayit Sunnyvale CA 94089 Website http arrayit com CONFIDENTIAL JMAC 2007 2012 All Rights Reserved 125 33 PATHWORK DIAGNOSTICS Dr David Craford Chief Commercial Officer 2008 Tissue of Origin FDA IVDMIA 15 2010 Tissue of Origin
290. GENEWAVE S A S XTEC Bat 404 Ecole Polytechnique Campus 91128 Palaiseau France Tel 33 1 6933 1575 Fax 33 1 6933 1576 Website www genewave com Genewave RNA RT PCR microarray ROCHE HOLDING AG Konzern Hauptsitz Grenzacherstrasse 124 Base Switzerland Tel 41 61 688 1111 Fax 41 61 691 9391 Website www roche com 2009 93 NimbleGen 454 Life Sciences 6Genentech 20 AmpliChip TaqMan real time PCR Ventana Medical Systems in situ Elecsys
291. IVD FDA IVD IVD B IVD FDA IVD 2 IVD FDA IVD IVD
292. 8 2 2 4 2 8 2 4 2 8 2 9 IEC62304
293. 3 MAQC SPIDIA 1 MAQC I SPIDIA WG WG WG O 2 WG 1 FDA
294. 44 SOP SOP C DNA QA QC DNA
295. K2EDTA RNA PAXgene RNA 2 RNA SPIDIA University of Florence RNA ME SB Agilent RIN GAPDH ILIB IL8 c fos qPCR Kineret 3
296. 2 DNA 0118 1 22 1 18 4 EEO 3 0528 1 22 05 28 2 4 1215 1 22 12 15 3 95 WG HP UP 19 GARR Seth ZE EA WG HP RE EPS ERMSR GRA k5 1088 BEI F 9 IN A http dmd nihs go jp jisedai Dy
297. 2007 5 31 HPV DNA oe 1 BAF 2009 7 30 99 DNA DNA Lataa 22 DNA Agendia MammaPrint pees of Origin Test MammaPrint sp 5 eRe FDA I Saree yh Ares da Tissue of Origin COMSNEMMICITO 0 Wx PORRE METS EERI S008 BILE Ae OR RRMORRELECC MEMOS 9 2007 2 MammaPrint A z FDA BEER DaceaeM aOR 9296 WO kare
298. SOLID DNA DNA PCR DNA 5 2 6 Ion Torrent Systems Inc DNA
299. INFORM HER2 Dual ISH DNA Probe Cocktail MUC 1 TG4010 MVA MUC1 IL2 AF802 cobas e 301 C PCR R7128 C PCR PCR SLE FLT 3ITD PMA AC220 FLT 3 179 hENT1 expression CP 4126 ALK FISH CISH AF802
300. RNA H amp E RNA cRNA RNA
301. FFPE FDA IVDMIA 2010 IVDMIA PMA LDT IVD FDA 595 Penobscot Dr P athwor k Redwood City CA 94063 Website pathworkdx com CONFIDENTIAL JMAC 2007 2012 All Rights Reserved 34 PHALANX BIOTECH GROUP Dr Lester Lien President US Office 2004 99 160 250 MAQC FDA CE 1301 Shoreway Rd Ste 160 i Belmont CA 94002 Phalanx Website See www phalanxbiotech com CONFIDENTIAL JMAC 2007 2012 All Rights Reserved 126 BIOCARTIS SA Mr Nader Donzel Chief Technical Officer Dr Nicolas Demierre Head of Engineering 2010 Royal Philips Electronics
302. PBMC RNA RNA RNA RNA RNA RNA 1 RBC RBC 0 2 42 RNA mRNA 70 mRNA RNA mRNA
303. 4 G O in Vvitro in vivo 5 CONFIDENTIAL JMAC 2007 2012 All Rights Reserved 2011 8 15 Draft Guidance for Industry and Food and Drug Administration Staff Factors to Consider when Making Benefit Risk Determinations in Medical Device Premarket Review DRAFT GUIDANCE FDA CONFIDENTIAL JMAC 2007 2012 All Rights Reserved 117
304. MAQC I SPIDIA MAQC SPIDIA 3 3 1 3 1 1 1 WG 1 23 11 16 15 00 17 00 2 2 3 Se BS KIR 4 1
305. 4 RNA DNA DNA DNA RNA 80 5 6
306. DNA 2 2 WG 1 1 1 DNA 1 2 1 3 1 4 2 2 1 1 DNA 2 2 2 1 2 2 3 1 2 3 4 5 2 4 1 2 3 4 5 105 2 5 1 2 2 6 2 7 1 DNA 2 3 3 1 3 2 3 3 3 4 3 5
307. FFPE PAXgene Tissue System 3 2 6 RING TRIAL RING TRIAL EFCC European Federation of Clinical Chemistry and Laboratory Medicine 30 219 322 2012 2 155 RING TRIAL Programme DNA Ring Trial BMI CMR MHS DNA DNAplas Ring Trial as SPDIA LAB real time PCR RNase P DNA as SPD
308. 14 1 3 0 OON OOF CONFIDENTIAL JMAC 2007 2012 All Rights Reserved 119 21 11 12 13 14
309. D N A 1 1 23 DNA DNA DNA FDAMAQC E SPIDIA DNA
310. 152 SEQC SEQC Standard Operating Procedures
311. DNA DNA 2007 19 5 18 19 21 22 23 22 DNA 2007 MAQC I SPIDIA DNA
312. IHC POR Met RG3638 MetMAb Met Gc 33 3 PCR LY2784544 RotorGene Q JAK2 V617F 2011 12 19 180 7 2011 7 FDA
313. RNA RNA RNA RNA RNA RNA SOP http www fda gov nctr science centers toxicoinformatics maqc docs MAQC_Sample_ Processing Overview_SOP pdf o 1 RNA RNA RNase RNase RNA
314. 0 70 0 79 2 3 DNA 75 3 5 4 1 Inoue A Yoshida N Omoto Y Oguchi S Yamori T Kiyama R and Hayashi S 2002 Development of cDNA microarray for expression profiling of estrogen responsive genes J Mol Endocrinol 29 175 192 2 Terasaka S Aita Y Inoue A Hayashi S Nishigaki M Aoyagi K Sasaki H Wada Kiyama Y Sakuma Y Akaba S Tanaka J Sone H Yonemoto J Tanji M and Kiyama R 2004 Expression profiling of the estrogen responsive genes for evaluation of estrogen activity among natural estrogens and industrial chemicals using a customized DNA microarray Environ Health Persp 112 773 781 3 Ise R Han D Takahashi Y Terasaka S Inoue A Tanji M and Kiyama R 2005 Expression Profiling of the Estrogen Responsive Genes in Response to Phytoestrogens Using a Customized DNA Microarray FEBS Lett 579 1732 1740 4 Terasaka S Inoue A Tanji M and Kiyama R 2006 Expression profiling of estr
315. 2011 2011 PAXgene Tissue System 2011 Deutsche Gesellschaft f r Pathologie PAXgene PAXgene RNA FFPE 2011 Biospecimen Research Network NCI PAXgene PAXge
316. 4 1 14 2 1 0 1 4 1 15 GMP LDT DNA
317. BIOCARTIS ELISA Enzyme Linked ImmunoSorbent Assay ELISA 2 3 BIOCARTIS 5 1 0 ELISA 10 15 BIOCARTIS 2 DNA RNA FDA PMA IVDMIA FDA 5 Ohm
318. wew 2b PCR HER2 HER2 PCR HLA B5701 BRAF V600 COBAS 4800 BRAF FDA V600 BRAF V600 27 2011 8 ALK Vysis ALK Break FDA Apart FISH Probe Kit ALK 2011 8 2011 3 CCR 4 KW 0761 EH
319. 2 DNA 3 DNA 4 4 1 WG 1 4 2 WG 2 4 3 FDA 5 DNA 2011 DNA 22 WG 6 DNA 6 1 II 2007 5 9 6 2 Class II Special Controls Gene Expression Profiling Test System for Breast Cancer Prognosis May 9 2007 6 3 Tin vitro 2007 7 26 6 4 In Vitro Diagnostic Multivariate Index AssayS July 26 2007 6
320. 6 TRMSAC 1 6 7 GLPTYP GLP FDA 8 QARPT QA 9 DURDOS 6 10 Sprague Dawley 6 STTITL 11 ALTSTDID ID ID 123456 12 SENDVER SEND 2 3 13 STDTC 2001 5 1 14 ENDTC 2001 7 1 15 2 RIFE USUBJI ARMC SCTESTC SCORRE SCSTRES D D D S SCTEST C SCSEQ 1 1 SEX Male 1 2 1 SEX Male 2 3 1 SEX Male 3 4 1 SEX Male 4 5 1 SEX Male 5 6 2 SEX Male 6 7 2 SEX Male 7 8 2 SEX Male 8 9 2 SEX Male 9 10 2 SEX Male 10 3 AEAFIE ARMCD GCTESTCD GSCORRES GCTEST GCSRESC GCSEQ GRPNAM Low dose 1 1 CTLGRPDFL N N 2 2 GRPNAM Control 3 2 CTLGRPDFL Y Y 4 57 4 Hee USUBJID ARMCD EXTRT EXIRIV EXDOSE EXDOSU EXDOSFRQ EXDOSFRI EXDOSTOT EXROUTE EXDUR EXGRPID EXSEQ STDY ENDY 1 1 X Labrafil 10 mg kg 1 1 10 PO 1 1 1 6 2 1 X Labrafil 10 mgg 1 10 P6D 1 2 1 6 3 1 X Labrafil 10 mgg 1 F 10
321. DNA FDA F 1 8 1 9 2 1 2 3 DN A 2 0 0 7 Eee 5 TS 1 9 DN A IVDMTIA 98 DNA DNA DNA DNA DNA 2009 FDA 2009 IVDMIA
322. DNA 81 ISO DIS16578 GMP QMS ISO13485 2 GMP QMS ISO13485 uji a bh DNA 1 2 3 6 7 3 2 DNA 1 RNA
323. FDA 2011 IVDMIA LDT FDA IVDMIA 1 2 FDA Ox LDT IVD FDA CMS LDT Laboratory Developed Tests CMS CLIA FDA IVD
324. MAQC 50 RNA MAQC RNA 2 A 3 A1 A2 A3 B 3 B1 B2 B3 RNA
325. 23 JCCLS 12 135 2 1 IVD 2 1 1 Draft Guidance for Industry and Food and Drug Administration Staff In Vitro Companion Diagnostic Devices DRAFT GUIDANCE 2 1 2 U S Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health CDRH Center for Biologics Evaluation and Research CBER Center for Drug Evaluation and Research CDER FDA 2 1 3 2 1 FDA FDA
326. NATURE BIOTECHNOLOGY 2 400 DNA DNA 1 5 cRNA Affymetrix HeLa MCF 7 1
327. 2 24 1 12 SPIDIA SPIDIA 2011 10 1 SPIDIA Newsletter 10 2011 October 2011 SPIDIA 2011 10 SPIDIA www SPIDIA eu SPIDIA SPIDIA SPIDIA SPIDIA Contact Us www SPIDIA_ eu SPIDIA
328. 3 A 1 2 3 STP Toxicologic Pathology 32 126 131 2004
329. 3 2 2 2 2 24 1 12 PSS 20 DNA OEM Roche QIAGEN 7 OEM RNA RNA
330. 4 2 2010 5 WG 5 1 2010 WG 22 DNA E WG 23 3 14 28 5 2 WG WG 6 DNA 6 1 DRAFT GUIDANCE Pharmacogenomic Data Submissions August 24 2007 6 2 DRAFT GUIDANCE Pharmacogenomic Data Submissions August 24 2007 6 3 SPIDIA Newsletter 10 2011 October 2011 6 4 SPIDIA Newsletter 10 2011 October 2011 6 5 The MicroArray Quality Control MAQC II study of common practices for the development and validation of microarray based predictive models Nat Biotechnol 2010 Aug 28 8 827 38 5 2007 2010 2007 2010 BE WG WG WG W
331. FDA JAD Bik
332. RNA RNA RNA 3 RNA RNA RNA 4 RNA DNA DNA DNA RNA
333. FDA PMA PMA gt CONFIDENTIAL JMAC 2007 2012 All Rights Reserved Reflection paper on methodological issues associated with EUROPEAN MEDICINES AGENCY pharmacogenomic biomarkers in relation to
334. RNA 47 F
335. microRNA Roche miRNA SCANDINAVIAN MICRO BIODEVICES APS Scandinavian Micro Biodevices SMB 2000 POC 171 Gammelgaardsvej 87C DK 3520 Farum Denmark Tel 45 7020 7303 Fax 45 2003 Alere 2006 7020 7304 Website www smb dk SMB 5 5 1 Sanger 1 50 L
336. Reena Philip 240 276 1286 reena philip fda hhs gov Division of Dockets Management Food and Drug Administration 5630 Fishers Lane Room 1061 HFA 305 Rockville MD 20852 http www fda gov dockets ccomments 2007D 0137 http www fda gov cdrh oivd guidance 1627 pdf dsmica fda hhs gov 240 276 3151
337. UK EGFR Pathwork FDA 2 1 Tissue of Origin 1 Tissue of Origin FFPE PMA FDA IVDMIA Tissue of Origin 2 5 Tissue of Origin FFPE 9 FDA IDE Investigation Device Exemption FDA Genomic Health t 0OncoType CLIA FDA FDA 4 2 4 BIOCARTIS SA Mr Nader Donzel Chief Technical Officer Dr Nicolas Demierre Head of Engineering 2012 02 13 Biocartis
338. DNA DNA BMP
339. FDA CDISC SDTM FDA Web 29 VI a 52 3 1 2
340. Lea lt lt lt haat 38 3 4 3 SPIDIA kk 63 3920NA REN 73 EERE ET EH A REA AE E EEA E A A A EA 73 RE T D A oto tn Dd TEE TE 73 5 3S tea eae Ove R hia a aa ana eee 75 3 5 4 76 Ae FA 227 teen Tir oe Sats sat edie ea ana yl Ra ea a anata 77 DNA 2011 R 5 86 6 23 kk 87 1 2 DNA 3 3 1 DNA 3 2 23 DNA 1
341. 90 1 1 91 The Guideline Program for Medical Device Development DNA hi ge an BETE 1 RGM EER DOH TOS 92 gt gt
342. 2 3 2 3 DNA WG 2 4 3 23 DNA 6 xz JCCLS DNA bb DNA WG
343. 2004 National Genetics Reference Laboratory Automated Extraction Methodologies DNA System type Chemistry Dimensions Presence Integrity E PCR OD260 280 Cross contamination RNA Qiagen
344. 6 7 3 8 4 1 4 2 4 2 1 1 2 4 2 1 1 2 3 4 2 2 DNA WG 23 WG JCCLS 23 WG 3
345. 82 Eis 3 5 24 11 20 1120 5 2 RNA 3 6 24 11 20 1120 5 2 RNA 3 7
346. 1 2 JIS 3 4 18 DNA
347. 1 RNA RNA RNA 2 RNA RNA RNA RNA RNA RNA 3 RNA RNA RNA
348. D N A nba ie salna of re i en EE wre DNA DNA P450 DNA P450 DNA AmpliChip CYP450 2007 2 5 P450 DNA Roche Diagnostics Affymetrix P450 2D6 32 2C19 2 34 2006 5 A Amplichip CYP450 20095 12 3 DNA DNA
349. DNA DNA PCR 2 21 DNA DNA DNA DNA DNA DNA DRO DNA
350. OECD GLP DNA SRL FDA
351. RNA 1 2 DNA DNA DNA DNA DNA DNA 2007 19 5 DNA DNA
352. 2004 5 2 2 Polony 2005 aired tag PCR 99 9999 10 1 Agencourt Biosciences Agencourt Personal Genomics Applied Biosystems SOLID 5 2 3 454 454 Life Sciences Roche Diagnostics PCR DNA 175 DNA 1 1 1 DNA
353. DNA 2009 FDA 2009 IVDMIA DNA MammaPrint HEI Agendia 70 DNA DN A DNA 2007 6 15 DNA
354. PO 1 3 1 6 4 1 X Labrafil 10 mgg 1 10 PO 1 4 1 6 5 1 X Labrafil 10 mgg 1 i 10 PO 1 5 1 6 6 2 Labrafil 10 mkg 1 10 PO 2 6 1 6 7 2 Labrafil 10 mg kg 1 a 0 PO 2 7 1 6 8 2 Labrafil 10 mg kg 1 0 PO 2 8 1 6 9 2 Labrafil 10 jnmgkg 1 0 PO 2 9 1 6 10 2 pe Labrafil 10 mg kg 1 F 0 PO 2 10 1 6 SDTM SDTM 225 http www fda gov cder regulatory erst Studydata v1_ 1 pdf 58 5 MAREE USUB CPTES CPST CPSTR CPSP CPC CPSC CPTE CPSTR CPOR CPORR CPGR CPS DY JID TCD ESN ESU EC AT AT ST ESC RES ESU PID EQ 1 MONO 0 48 10E 9 HEM BER 0 484 0 48 10E 9 1 1 6 4 L 4 L 2 MONO 0 41 10E 9 HEM BER 0 418 0 41 10E 9 1 2 6 8 L 8 L 3 MONO 0 42 10E 9 HEM BER 0 429 0 42 10E 9 1 3 6 9 9 L 4 MONO 0 44 10E 9 HEM BER 0 447 0 44 10E 9 1 4 6 7 L 7 L 5 MONO 0 47 10E 9 HEM ER 0 471 0 47 10E 9 1 5 6 1 L 1 L 6 M
355. QIAGEN RNeasy Plus Mini RNA DMSO b mRNA RNA RNA DNA RNA aRNA a RNA SuperScript RNA Amplification System mRNA c cDNA b RNA SuperScript Indirect cDNA Labeling System cDNA Cy3 cDNA cDNA 12 TE d DNA c cDNA DNA 65C FLA 8000 FujiFilm
356. SNP FDA FDA IND NDA BLA VGDS FDA FDA
357. 1 100 Gb 35 bp 55 bp 5 1 3 Roche454 MiSeq PacBio RS ion torrent 40Mb 1Gb 1 6Gb 0 175Gb 400bp 150bp 2 gt 1000 bp 1000bp 10 27 2 2 48 12 12 6 15 16 5 2 5 2 1 MPSS 3 amp Massively Parallel Signature Sequencing 1990 o MPSS Lynx Therapeutics 1 SBS MPSS MPSS cDNA
358. 21 DNA 2010 23 DNA 2011 R 4 2 3 3 3 DNA DNA DNA
359. 4 1 5 1 0 4 4 1 6 7 GMP 159 4 1 7
360. RNA RNA RNA 80 C RNA RNase 20 C RNA RNase 3 PBMC RNA RNA PBMC ET PBMC lt
361. RNase 0 1 mM EDTA TE RNA 80 C M RNA 80 C 1 RNA 20 C 5 RNA QC RNA 260nm 280nm RNA 2 RNA RNA 43 260nm 280 nm A260 A280 RNA 1 8 1
362. microfluidics optofluidics and integrated optics MDXHEALTH S A Tour 5 GIGA niveau 3 Av de Hopital 11 4000 Liege Belgium Tel 32 4 364 2070 Fax 32 4 364 2071 Website www oncomethylome com OncoMethylome Sciences SA 2010 CLIA LabCorp III DIA 2010 1500 PAMGENE INTERNATIONAL B V Nieuwstraat 30 5211 NL s Hertogenbosch The Netherlands Tel 31 73 615 8080 Fax 31 73 615 8081 Website www pamgene com 2000 PamGene 15 O 144 PEPSCAN PRESTO BV Zuidersluisweg 2 B243 RC Lelystad The Netherlands Tel 31 320 225300 Fax 31 320 225301 Website www pepscan com PepChip
363. Imperial College London Reveo Carbon nanotube Arizona State Univ Graphene California State Univ Univ of Pennsylvania Kavli Institute of Nanoscience http genaport genar is com GOC_sequencer_post php eid 00001 5 1 2 Gene Analyzer IIx 2x 150bp 5 HiSeq1000 2000 173 1 540 600G b 30x MiSeq 2x 150bp 27 1 5 2 0Gb SOLiD SOL i D5500x 1 1 20 30Gb DNA 1 2 24 12
364. classifier 2 SPIDIA 3 WG Ra 4 y 5 1 2 4 1 RNA RNA RNA 2 RNA RNA RNA
365. 310 k 4 26 FDA
366. DNA 1 1 5 2 7 DNA DNA DNA DNA 176 5 ol ol 1 ol DNA
367. ER 21 CFR 862 2570 FDA FDA II 510 k 310 k
368. RNA RNA 1 2 3 4
369. 3 9 11 1 2 3 JIS 88 DNA
370. DNA ISO O WG O
371. Bio lon Torrent Systems Pac lon Bio Torrent 1 25 400 1000 10 kb 100 200 lon Pac Bio Torrent 172 DNA 454 Ilumina Helicos Intelligent Bio Systems LaserGen Lightspeed Genomics DNA SOLiD Complete Genomics Danaher Motion Polonator GnuBio 1 DNA Pacific Biosciences Life Technologies VisiGen Cracker Columbia Univ Harvard Univ Mobious Biosystems GE Healthcare Univ of California San Diego Oxford Nanopore Univ of Washington Electronic Bio Sciences NABsys IBM NobleGen Biosciences Stratos Genomics Kavli Institute of Nanoscience on Torrent Systems GenaDSys DNA Caerus Molecular Diagnostics Halcyon Molecular ZS genetics Tunneling signal Arizona State Univ
372. FDA RES 5 6 O 1 3 O MAQC I SPIDIA
373. President PATHWORK DIAGNOSTICS Dave Craford CCO PHALANX BIOTECH GROUP Dr Lester Lien President US office BIOCARTIS Dr Nader Donzel CTO ONO 4 2 1 ARRAYIT CORPORATION Dr Mark Schena CEO 2012 2 9 1993 DNA 0OvaDx FDA PMA Sunnyvale CA 94089 162 Arrayit JMAC DNA 100gene JMAC
374. RNA RT PCR SPIDIA i ii microRNA 3 155 mCRC 139 IH NMR 68 1H NMR mCRC
375. false negative false positive false negative 4 3 100
376. gather the data needed and complete and review the information collection 2 An Analysis of Blood Processing Methods to Prepare Samples for GeneChip Expression Profiling Technical Note from Affymetrix http www affymetrix com support technical technotes blood_technote pdf 3 Fan H 2005 The transcriptome in blood challenges and solutions for robust expression profiling Current Molecular Medicine 5 3 10 4 Debey S et al 2006 A highly standardized robust and cost effective method for genome wide transcriptome analysis of peripheral blood applicable to large scale clinical trials Genomics 87 653 664 5 Burczynski M E and Dorner A J 2006 Transcriptional profiling of peripheral blood cells in clinical pharmacogenomic studies Pharmacogenomics 7 187 202 6 Baechler E C 2004 Expression levels for many genes in human peripheral blood cells are highly sensitive to ex vivo incubation Genes and Immunity 5 347 353 7 Debey S 2004 Comparison of different isolation techniques prior gene expression profiling of blood derived cells impact on physiological responses on overall expression and the role of different cell types The Pharmacologics Journal 4 193 207 8 http arrayconsortium tgen org np2 public qualitycontrol jsp 9 Dumur C I et al 2004 Evaluation of quality control criteria for microarray gene expression analysis Clinical Chemistry 50 11 1994 2002 10 Imbeaud S Graudens E Boulan
377. reference material Coriell CDC Genetic Testing Reference Material Coordination Program GeT RM QC CDC 85 5 DNA 2010
378. 1215 1 22 12 15 3 94 Ministry of Economy Trade and Industry gt gt gt HP http www meti go jp polic EPE mono_info_service service LDNAF Z pent 160K PI iryou_fukushi index html PDF 236KB E RBI 0404002 20 4 4 R RHR ODECLES A 4 0404002 20 4 4
379. 2 142 vv vv v false positive
380. AE3 7 Ki67 S100 pH OMB PAXgene HE FFPE Ergin et al J Proteome Res 2010 Oct 1 9 10 5188 96
381. Prediction Key esse no gt gt Treatment plan eee s We Tissue sample Microarray 1 Internal hn validation Process evaluated in MAQC II AE AUC 0 991 AUC 0 956 AUC 0 787 AUC 0 815 AUC Area under the receiver operating characteristic curve True positive rate sensitivity False positive rate 1 specificity 101 Nature Biotechnology MAQC II 28 pp827 838 6 9 6 13 6 Table 1 Microarray data sets used for model development and validation in the MAQC II project Training set Validation se Number Positives Negatives P N Number Posities Negatives of samples P N rath atio Hof samples P array MER COPA ESTE SAFER Affymetrix mouse amp human Amersham Agilent
382. System or Breast Cancer Prognosis 2007 PGx 2007 Good Laboratory Practices for Molecular Genetic Testing f a ale i ah eae tics 2000 oes ap craters Freres 28020 DNA NR 2007 TEEPE DNA z ol 2008 en EATENTADNANT INEN OECD 2007 OECD GUIDELINES FOR QUALITY ASSURANCE OECD IN MOLECULAR GENETIC TESTING Methods of analysis for the detection of genetically modified ISO GMO organisms and derived products 2010 NWIP CD General definitions and requirements for microarray detection of specific nucleic acid sequences 3 JMAC 2007 2012 All Rights Reserved DNA DNA OECD ISO rr CONFIDENTIAL JMAC 2007 2012 All Rights Reserved 111 201 1
383. 2005 Use of a mixed tissue RNA design for performance assessments on multiple microarray formats Nucleic Acids Res 33 e187 25 Reid LH et al 2006 Proficiency testing program for microarray facilities in preparation http www expressionanalysis com proficiency_test html 26 Shi L Reid LH et al 2006 MicroArray Quality Control MAQC Project A comprehensive survey demonstrates concordant results between gene expression technology platforms Nat Biotechnol 24 9 1151 1161 27 ICH guidance E3 Structure and Content of Clinical Study Reports 28 See http www fda gov oc datacouncil 29 The SDTM can be obtained from the CDISC Web site at http www cdisc org models sds v3 1 index html SDTM Implementation Guides The Study Data Tabulation Model Implementation Guide SDTM IG for clinical study data can be obtained from the CDISC web site at http www cdisc org models sds v3 1 index html The Study Data Specification for submitting SDTM datasets to CDER can be obtained at http www fda gov cder regulatory ersr Studydata v1 1 pdf 30 More information can be found at FDA Data Standards Council Web site http www fda gov oc datacouncil The Standard for Exchange of Nonclinical Data SEND Implementation Guide for Animal Toxicology Studies can be obtained from the CDISC Web site at http www cdisc org models send v2 3 SENDV2 3ImplementationGuide pdf 62 3 4 3 SPIDIA
384. 5 TI RNA RTF RT PCR RNA 2005 8 25 6 6 Class II Special Controls Guidance Document RNA Preanalytical Systems RNA Collection Stabilization and Purification Systems for RT PCR used in Molecular Diagnostic Testing August 25 2005 6 6 7 DRAFT GUIDANCE Pharmacogenomic Data Submissions August 24 2007 6 8 SPIDIA Newsletter 10 2011 October 2011 6 9 The MicroArray Quality Control MAQC II study of common practices for the development and validation of microarray based predictive models Nat Biotechnol 2010 Aug 28 8 827 38 5 3 O DNA DNA 18 19 21 19 DNA
385. 5 Food and Drug Administration 5630 Fishers Lane rm 1061 Rockville MD 20852 Federico Goodsaid CDER 301 796 1535 Raj Puri CBER 248 301 827 0471 CDER NCTR CBER CDRH 2007 8 38 HFD 240 5600 Fishers Lane Rockville MD 20857 301 827 4573 http www fda gov cder guidance index htm 1401 Rockville Pike Rockville MD 20852 1448 http www fda gov cber guidelines htm 800 835 4709 or 301 827 1800
386. CLIA IV FDA FDA
387. DNA 2007 19 20 DNA 2 2 DNA 18 19 21 22 23 22 DNA DNA DNA DNA
388. G WG WG 1 R WG WG 19 ISO MAQC DNA DNA DNA WG
389. IA DNA DNA RNA EQA SPIDIA EFCC European Federation of Clinical Chemistry and Laboratory Medicine http www efcclm eu 322 30 219 SPIDIA DNA DNAplas 66 SMPRZLTNTH MRELSMRBASSITMY SYAREORS DNA DNA DNA SPIDIA University of Florence DNA
390. IA LAB DNA Isohel ix Quality Check Kit DNA Agilent DNA Kit t DNA Kineret software RNA Ring Trial RNA K2EDTA PAXgene as SPDIA LAB by integrity Agilent RIN PCR Kineret software RING TRIAL SPIDIA LAB DNA RT PCR RNase P DNA nA mi DNA RNA K2EDTA PAXgene 156 DNA DNAplas RNA RING Trial Ring Trial Name What do you What do you What does SPIDIA receive extract evaluate SPIDIA DNA Whole blood sample Genomic DNA Qual ity Quantity SPIDIA DNAplas Whole blood sample Genomic DNA Qual ity Quantity Plasma sample Cell free DNA Quantity Integr ity SPIDIA RNA Whole blood sample RNA Qual ity Quantity Stability SPIDIA
391. ONO 0 44 10E 9 HEM BER 0 441 0 44 10E 9 2 6 6 1 L 1 L 7 MONO 0 40 10E 9 HEM BER 0 407 0 40 10E 9 2 7 6 7 L 7 L 8 MONO 0 44 10E 9 HEM BER 0 448 0 44 10E 9 2 8 6 8 L 8 L 9 MONO 0 40 10E 9 HEM ER 0 408 0 40 10E 9 2 9 6 8 L 8 L 10 MONO 0 41 10E 9 HEM BER 0 418 0 41 10E 9 2 10 6 8 L 8 L 1 ALT 57 U L CHE ALT 57 57 U L 1 11 6 M 2 ALT 44 UL CHE ALT 44 44 U L 1 12 6 M 3 ALT 42 U L CHE ALT 42 42 U L 1 13 6 M 4 ALT 39 U L CHE ALT 39 39 U L 1 14 6 M 5 ALT 45 U L CHE ALT 45 45 U L 1 15 6 M 6 ALT 39 U L CHE ALT 39 39 U L 2 16 6 M 7 ALT 40 U L CHE ALT 40 40 U L 2 17 6 M 8 ALT 40 U L CHE ALT 40 40 U L 2 18 6 M 9 ALT 39 U L CHE ALT 39 39 U L 2 19 6 M 10 ALT 38 UL CHE ALT 38 38 U L 2 20 6 M SOTM SDTM 2 2 http www fda gov cder regulatory ersr Stu
392. Systemi E PR MIRNA ROR Mb ZR KFS RNA 1 RT PCR RNA RNA PAXgene Blood RNA System mw RNA e RNA 18 25 C 3 2 8 C 5 20C 70C 50 e RNA
393. TAA SPIDIA 2 2 CTC 2 SPIDIA 2 SPIDIA SPIDIA SPIDIA SPIDIA 250 SPIDIA Uwe Oelmueller Mario Pazzagli Christian Viertler
394. VIL A B C I EXPSUMTABLE II FDA FDA FDA FDA I 2005 3 A
395. atory Practices for GLP Molecular Genetic Testing for 134 Heritable Disease and Conditions DNA 2007 DN A BE DNA DNA 2008 DNA OECD 2007 OECD GUIDELINES FOR QUALITY OECD ASSURANCE IN MOLECULAR GENETIC TESTING ISO GMO Methods of analysis for the detection of genetically modified organisms and derived products 2010 NWIP CD General definitions and requirements for microarray detection of specific nucleic acid sequences 2 2 2 IVD 2011 Draft Guidance for Industry and FDA 7 14 Food and Drug Administration Staff In Vitro Companion Diagnostic Devices DRAFT GUIDANCE
396. bH MEMS Lilliput Chip FEBIT BIOTECH GMBH Im Neuenheimer Feld 519 D 69120 Heidelberg Germany Tel 49 6221 6510 300 Fax 49 6221 6510 329 Website www febit com Geniom DNA sequence information miRNA ACT INOSTICS GMBH Falkenried 88 20251 Hamburg Germany Tel 49 40 413 373 90 Fax 49 40 413 383 99 Website www inostics com BEAMing technology PCR JPT PEPTIDE TECHNOLOGIES GMBH Volmerstrasse 5 UTZ 12489 Berlin Germany Tel 49 30 6392 5500 Fax 49 30 6392 5501 Website www jpt com PEPPERPRINT GMBH Rischerstrasse 12 D 69123 Heidelberg Germany Tel 49 6221 72644 88 Fax 49 6221 72644 75 Website www pepperpr int com 20 PROTAGEN AG BIOTECHNOLOGIE Otto Hahn Strasse 15 Dor
397. clinical development and patient selection 2011 7 12 EMA 2011 11 25 OMDNOAHRWAN CONFIDENTIAL JMAC 2007 2012 All Rights Reserved 118 JCCLS DNA RNA CONFIDENTIAL JMAC 2007 2012 All Rights Reserved 20 DNA JMAC
398. dical Device Premarket 148 Review 3 1 4 FDA MAQC II MAQC II MAQC II Dr Leming Shi 2012 3 MAQC II Nature Biotechnology 28 827 838 1 August 2010 DISCUSSION MAQC II
399. dydata v1 1 pdf 59 6 MRENA USUBJID MITESTC MISTA MIREASN MIGRPI MISE D D MITEST MIORRES T D D Q DY 1 LIVER 1 1 2 LIVER 1 2 3 LIVER 1 3 4 LIVER 1 4 5 LIVER 1 5 6 LIVER 2 6 7 LIVER 2 7 8 LIVER 2 9 9 LIVER 2 9 10 LIVER 2 10 60 gt Do DD gt 1 This guidance has been prepared by the Center for Drug Evaluation and Research CDER the National Center for Toxicological Research NCTR and the Center for Biologics Evaluation and Research CBER in cooperation with the Center for Devices and Radiological Health CDRH at the Food and Drug Administration For the purposes of this guidance the term drug or drug product includes human drug and biological products Paperwork Reduction Act Public Burden Statement According to the Paperwork Reduction Act of 1995 a collection of information should display a valid OMB control number The valid OMB control number for this information collection is 0910 0557 expires 12 31 2007 The time required to complete this information collection is estimated to average 10 hours per response including the time to review instructions search existing data resources
400. ger V Barlet X Zaborski P Eveno E Mueller O Schroeder A and Auffray C 2005 Towards standardization of RNA quality assessment using user independent classifiers of microcapillary electrophoresis traces Nucleic Acids Research 33 6 e56 External RNA Controls Consortium 2005 The External RNA Controls Consortium a progress report Nature Methods 2 731 734 http edkb fda gov MAQC e Shi L Tong W Su Z Han T Han J Puri R K Fang H Branham W S Chen J J Xu Z Harris S C Hong H Xie Q Perkins R G and Fuscoe J C 2005 Microarray scanner calibration curves characteristics and implications BMC Bioinformatics 6 Suppl 2 S11 4 Simon R Development and evaluation of therapeutically relevant predictive classifiers using gene expression profiling 2006 J Natl Cancer Inst 98 17 1169 71 5 Simon R 2006 A checklist for evaluating reports of expression profiling for treatment selection Clin Adv Hematol Oncol 4 3 219 24 6 Dobbin KK Simon RM 2007 Sample size planning for developing classifiers using high dimensional DNA microarray data Biostatistics 8 1 101 17 7 Varma S Simon R 2006 Bias in error estimation when using cross validation for model selection BMC Bioinformatics 7 91 8 Guo L Lobenhofer EK Wang C Shippy R Harris SC Zhang L Mei N Chen T Herman D Goodsaid FM Hurban P 61 Phillips KL Xu J Deng X Sun YA Tong W Dragan YP Shi L 2006 Rat
401. le Disease and Conditions lt DNA 2007 cue A DNA 5 ey t lt DNA 2008 J FE DNA OE D OECD SO GMO Methods of analysis for the detection of genetically modified organisms and derived products 2010 NWIP CD General definitions and requirements for microarray detection of specific nucleic acid sequences 2011 DNA 2 DNA DNA DNA DNA MammaPrint FDA
402. ml DGP 2011 2011 6 16 19 _ Sibylle Gidisch PAXgene http www pathologen kongress de 23 GCP2011 2011 8 27 9 1 71 _Christian Viertler _Marcel Kap PAXgene _Sibylle Gidisch http www esp congress org MipTec 2011 2011 9 19 22 _Uwe Oelmiiler SPDIA http www miptec ch 2011 10 10 11 _Sibylle Gidisch _Sibylle Gadisch
403. ne Hl 2011 Biospecimen Research Network 60 NCI 2010 AMP meeting AROS small RNA miRNA RIN miRNA SPIDIA not best tool QIAsymphony 2010 BBMRI Meeting BBMRI Biobanking and Biomolecular Resources Research Infrastructure 157 PAXgene 4 DNA DNA
404. of Conduct www tubafrost org PEC SPIDIA http www spidia eu SPIDIA SPIDIA SPIDIA SPIDIA PEC
405. ogen responsive genes in breast cancer cells treated with alkylphenols chlorinated phenols parabens or bis and benzoylphenols for evaluation of estrogenic activity Toxicol Lett 163 130 141 5 Dong S Inoue A Zhu Y Tanji M and Kiyama R 2007 Activation of rapid signaling pathways and the subsequent transcriptional regulation for the proliferation of breast cancer MCF 7 cells by the treatment with an extract of glycyrrhiza glabra root Food Chem Toxicol 45 2470 2478 6 Parveen M Inoue A Ise R Tanji M and Kiyama R 2008 Evaluation of estrogenic activity of phthalate esters by gene expression profiling using a focused microarray EstrArray Environ Toxicol Chem 27 1416 1425 7 Parveen M Zhu Y and Kiyama R 2009 Expression profiling of the genes responding to zearalenone and its analogues using estrogen responsive genes FEBS Letters 583 2377 2384 8 Dong S and Kiyama R 2009 Characterization of estrogenic activity of ginsenosides in MCF 7 cells using a customized DNA microarray Food Chem 113 672 678 9 Xu Q Hamada T Kiyama R Sakuma Y and Wada Kiyama Y 2008 Site specific regulation of gene expression by estrogen in the hypothalamus of adult female rats Neurosci Letts 436 35 39 10 Zhu Y Ogaeri O Suzuki J 1 Dong S Aoyagi T Mizuki K Takasugi M Isobe S i and Kiyama R 2011 Application of Fluolid Orange labeled probes for DNA microarray and immunological assay
406. pH EDTA 20 C 80 C DNA C 49 EM PM IM UM
407. s Biotechnol Letts 33 1759 1766 11 Dong S Furutani Y Suto Y Furutani M Zhu Y Yoneyama M Kato T Itabe H Nishikawa T Tomimatsu H Tanaka T Kasanuki H Masaki T Kiyama R and Matsuoka M 2012 Estrogen like activity and dual roles in cell signaling of an Agaricus blazei Murrill mycelia dikaryon extract Microbiol Res 167 231 237 76 4 DNA 2011 R 1 1 1 DNA DNA DNA HS CM DNA DNA DNA DNA
408. sed in this section as an example of a minimum time point It is possible that some studies may have endpoints exceeding five years 5 The use of banked leftover specimens is discussed in FDA s guidance Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable 6 Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices 3 4 2 FDA 2 2 24 1 12 FDA II DRAFT GUIDANCE Pharmacogenomic Data Submissions August 24 2007 Federal Register 90 Division of Dockets Management HFA 30
409. tion IND Investigational new drug CONFIDENTIAL JMAC 2007 2012 All Rights Reserved 7 IVD Bee NR Cra eae FDA FDA CONFIDENTIAL JMAC 2007 2012 All Rights Reserved 113 IVD O
410. tmund 44227 Germany Tel 49 231 9742 6300 Fax 49 231 9742 6301 Website www protagen de UNI chip UNIclone SIEMENS AG VERSANT HCV RNA 3 0 Assay bDNA 4 LJL4t OH 169 Healthcare Sector Henkestrasse 127 D 91052 Erlangen Germany Tel 49 69 797 6602 Fax 49 911 895 15 7999 Website www medical siemens com 2008 FDA V SIGNATURE DIAGNOSTICS AG Hermannswerder 20 A 14473 Potsdam Germany Tel 49 331 2000 200 Fax 49 331 2000 209 Website www signature diagnostics de Kinks Detector C Predictor C SIRS LABS GMBH Otto Schott Strasse 15 07745 Jena Germany Tel 49 3641 3103 100 Fax 49 3641 3103 102 Website www sirslab de DNA PCR microarray
411. toxicogenomic study reveals analytical consistency across microarray platforms Nat Biotechnol 24 9 1162 1169 19 Canales RD Luo Y Willey JC Austermiller B Barbacioru CC Boysen C Hunkapiller K Jensen RV Knight CR Lee KY Ma Y Magsodi B Papallo A Peters EH Poulter K Ruppel PL Samaha RR Shi L Yang W Zhang L Goodsaid FM 2006 Evaluation of DNA microarray results with quantitative gene expression platforms Nat Biotechnol 24 9 1115 22 20 Smythe et al BMC Infectious Diseases 2002 2 13 21 Yokota et al Journal of Clinical Laboratory Analysis 1999 13 133 140 22 Shi L Tong W Goodsaid F Frueh FW Fang H Han T Fuscoe JC and Casciano DA 2004 QA QC challenges and pitfalls facing the microarray community and regulatory agencies Expert Rev Mol Diagn 4 761 77 23 Shi L Tong W Fang H Scherf U Han J Puri RK Frueh FW Goodsaid FM Guo L Su Z Han T Fuscoe JC Xu ZA Patterson TA Hong H Xie Q Perkins RG Chen JJ and Casciano DA 2005 Cross platform comparability of microarray technology intra platform consistency and appropriate data analysis procedures are essential BMC Bioinformatics 6 Suppl 2 S12 24 Thompson KL Rosenzweig BA Pine PS Retief J Turpaz Y Afshari CA Hamadeh HK Damore MA Boedigheimer M Blomme E Ciurlionis R Waring JF Fuscoe JC Paules R Tucker CJ Fare T Coffey EM He Y Collins PJ Jarnagin K Fujimoto S Ganter B Kiser G Kaysser Kranich T Sina J and Sistare FD
412. work 2005 1 5 1 3 DNA DNA Imm 2mm 2006 RHO RNA
Download Pdf Manuals
Related Search