オンコマイン™ Dx Target Test マルチ CDxシステム（テンプ …

1 PT0002-ODxTT-Package Insert-E 23000 BZX00089000 17 71059003 Dx Target Test CDx DNA DNA DNA 1. 1) Oncomine Dx Target Test and Controls (1) Oncomine Dx Target Test - DNA and RNA Panel DNA 6 32 L RNA 6 32 L (2) Oncomine Dx Target DNA Control Oncomine Dx Target DNA Control 8 7 L (3) Oncomine Dx Target RNA Control Oncomine Dx Target RNA Control 8 7 L (4) Oncomine Dx Target RNA Control Diluent Oncomine Dx Target RNA Control Diluent 8 88 L (5) Ion Torrent Dx No Template Control Kit No Template Control 8 30 L 2) Ion PGM Dx Library Kit (1)

2 Ion PGM Dx Library Reagents LIB HiFi Mix 6 252 L LIB FuPa 6 32 L LIB Switch Soln 6 64 L LIB DNA Ligase 6 32 L BC1~16 12 L (2) Ion PGM Dx Library Equalizer LIB AMPure Reagents mL LIB Beads 6 48 L LIB Primers 6 36 L LIB Capture 6 160 L LIB Wash Soln 30 mL LIB Elution Soln mL 3) ion onetouch Dx Template Kit (1) ion onetouch Dx Template Reagents TMPL Enzyme Mix 400 L TMPL Rgnt Mix 8 500 L TMPL ISP 800 L TMPL CF-1 40 L (2) ion onetouch Dx Template ES Beads TMPL ES Beads 104 L (3) ion onetouch Dx Template Solutions TMPL Oil 450 mL TMPL Reaction Oil 22 mL TMPL Water 320 L TMPL Recovery Solution 280 mL TMPL Wash Solution mL TMPL Rgnt B 2 mL TMPL ES Rsp Soln mL TMPL Neutral Soln 80 L TMPL Tween Solution mL (4)

3 ion onetouch Dx Template Supplies 1 TMPL Amplification Plate 8 TMPL Recovery Router 8 TMPL Recovery Tubes 16 TMPL Sippers 2 TMPL Reagent Tube 2 TMPL ES Tip 8 TMPL ES Strip Tube 1 TMPL Cleaning Adapter 8 TMPL Emulsion Cartridge 8 TMPL Reagent Tube Labels 1 TMPL Sample Collection Tube 1 1 2. 1) Oncomine Dx Target Test - DN A and RN A Pa nel LIB HiFi Mix DNA DNA Oncomine Dx Target DNA Control Ion Torrent Dx No Template Control Kit RNA RNA Oncomine Dx Target RNA Control Ion Torrent Dx No Template Control Kit cDNA VRTi Dx 13B1X10227000004 LIB FuPa P1 16 A BC1 16 LIB DNA Ligase

4 P1 A LIB AMPure Reagents 100 pM LIB HiFi Mix LIB Primers LIB Beads LIB Wash Soln 100 pM LIB Elution Soln 2) ion onetouch Duo Dx 13B1X10227000006 ion onetouch Dx Template Kit 100 pM TMPL **2019 10 28 5 * 2019 4 16 4 PT0002-ODxTT-Package Insert-E Enzyme Mix dNTP TMPL Rgnt Mix TMPL Rgnt B TMPL ISP 2 TMPL CF-1 A P1 A P1 B ISP

5 B B P1- B TMPL Emulsion Cartridge ion onetouch Duo Dx Ion One Touch Dx DNA TMPL Amplification Plate Ion One Touch Dx PCR ISP Ion One Touch Dx ISP TMPL ES Beads 2 DNA dNTP ion onetouch Duo Dx ion onetouch ES Dx DNA 1 DNA ISP ISP TMPL Neutral Soln pH TMPL Sample Collection Tube 2 CF-1 A P1 2 CF-1 A CF-1 **3)

6 BRAF V600E EGFR ALK ROS1 EGFR COSMIC ID 18 >A E709K 12988 18 >C E709A 13427 18 >G E709G 13009 18 >T E709V 12371 18 >A G719S 6252 18 >T G719C 6253 18 >C G719A 6239 18 >A G719D 18425 19 del15 K745_E749del 26038 19 del15 K745_A750 delinsT 1190791 19 del10 E746_E749del 28517 19 del15 E746_A750del 6223 19 >AAT E746_T751 delinsI 13551 19 del15 E746_A750del 6225 19 del18 E746_T751del 12728 19 del15 E746_T751 delinsA 12678 19 >TTGCT E746_T751 delinsVA 12416 19 >T E746_S752 delinsV 12384 19 >GC L747_A750 delinsP 12422 19 >GCA L747_T751 delinsQ 12419 19 del18 E746_S752 delinsD 6220 19 del9 L747_E749del 6218 19 TTAAGAGAAG>C L747_A750 delinsP 12382 19 >C L747_T751 delinsP 12383 19 del18 L747_S752del 6255 19 >CA L747_P753 delinsQ 12387 19 del12 L747_T75 delinsS 6210 19 del15 L747_T751del 12369 19 del18 L747_P753 delinsS 12370 20 >T S768I 6241 20 >T T790M 6240 21 >G L858R 6224 21 >A L861Q 6213 21 >G L861R 12374 ** BRAF

7 V600E EGFR ALK ROS1 *1. 1) (1) DNA RNA DNA 10 ng RNA 10 ng PT0002-ODxTT-Package Insert-E DNA ng/ L RNA ng/ L (2) Torrent Suite Dx Software (3) Ion Torrent Dx FFPE Sample Preparation Kit Ion Torrent Dx cDNA Synthesis Kit RNA Oncomine Dx Target RNA Control Diluent Oncomine Dx Target Test RNA Control No Template Control VRTi Dx 13B1X10227000004 2)

8 (1) Torrent Suite Dx Software (2) DNA RNA LIB HiFi Mix DNA Oncomine Dx Target Test DNA Control No Template Control RNA VRTi Dx 13B1X10227000004 (3) LIB FuPa VRTi Dx (4) LIB Switch Soln BC1~16 LIB DNA Ligase VRTi Dx (5) LIB AMPure Reagent (6) LIB HiFi Mix LIB Primers VRTi Dx (7) LIB Wash Soln LIB Beads (8) LIB Capture (9) LIB Beads LIB Wash Soln (10) LIB Elution Soln 3) (1) Torrent Suite Dx Software Planned Run (2) (3) ion onetouch Duo Dx 13B1X10227000006 ion onetouch Dx (4) ion onetouch Dx Template Reagents ion onetouch Dx Template Solutions ion onetouch Dx Template Supplies ion onetouch Duo Dx ion onetouch Dx Planned Run (5)

9 ion onetouch Dx Template ES Beads ion onetouch Dx Template Solutions ion onetouch Dx Template Supplies ion onetouch Duo Dx ion onetouch ES Dx (6) ISP 4) 2. 1) 2) 15 30 C 3) *1. 1) (1) DNA RNA FFPE Ion Torrent Dx FFPE Sample Preparation Kit (2) FFPE 10 6 48 dsDNA FFPE