你所需-我所有-肿瘤液体活检方案有Thermo-Fisher就够%

Theworldleaderinservingscience,ProprietarybroadmolecularprofilingisakeycomponentoftheimprovementtocareofpatientswithNSCLC2,多基因检测为相关指南所推荐,精准治疗方案的制定离不开多基因检测，多种相关指南均建议实体肿瘤患者可尝试多基因检测。,JournalofMolecularDiagnostics,MolecularTestingGuidelineforSelectionofLungCancerPatientsforEGFRandALKTyrosineKinaseInhibitors.GuidelinefromtheCollegeofAmericanPathologists,InternationalAssociationfortheStudyofLungCancer,andAssociationforMolecularPathology15(4),July2013.NCCNClinicalPracticeGuidelinesinOncology(NCCNGuidelines),Non-SmallCellLungCancer,v8.2017,NCCN.org.Forinvitrodiagnosticuse.,实时的肿瘤分子分型有助于选择最为合适的治疗策略,Therapy1,Therapy2,Therapy3,EGFRExon19EGFRExon19(20%)EGFRExon19(29%)EGFRExon19(20%)KRASp.G13D(55%)T790M(6%)T790M(2%)METp.N375S(40%)P53p.G245V(10%)P53p.G245V(3%)METp.T1010I(20%)METp.N375S(59%)METp.N375S(55%),Baseline,Time1TBB/TTB,Time2Pleuraerguss(90%),Time3Liquidbiopsy(ctDNA),EGFR(Exon19),肿瘤分子分型的时空特异性治疗压力可能会导致肿瘤发Th变异，产Th耐药突变或者驱动基因的改变,3,2016ThermoFisherScientificCorporation.Allrightsreserved.,ForResearchUseOnly.Notforuseindiagnosticprocedures,液体活检可作为组织活检的有效补充,液体活检非侵入性的实时取样：为需要实时监控疗效的靶向治疗患者提供耐药监测的可能取样容易：为无手术样本或难以穿刺的肿瘤患者提供精准靶向治疗方案的可能,4,2016ThermoFisherScientificCorporation.Allrightsreserved.,ForResearchUseOnly.Notforuseindiagnosticprocedures,NCCNGuideline和CSCO指南的建议,中国临床肿瘤学会（CSCO）原发性肺癌诊疗指南2017.V1,5,2016ThermoFisherScientificCorporation.Allrightsreserved.,ForResearchUseOnly.Notforuseindiagnosticprocedures,液体活检的临床意义,治疗方案选择,疗效监控,复发监控,血液样本、手术样本及术后三天样本,3weeks为周期取样，持续6-8轮,3-6个月为周期取样,Solidtumorsample,中等灵敏度价格适中,高灵敏度低价,最高灵敏度低价,市场需求,适用平台,肿瘤患者疾病周期,一代测序：组织NGS(0.1%to1%LOD)：组织4:1269-1280,12,2016ThermoFisherScientificCorporation.Allrightsreserved.,晚期结直肠癌的靶向治疗：CSCO指南2017版,13,2016ThermoFisherScientificCorporation.Allrightsreserved.,OncomineColoncfDNAAssay：结直肠癌液体活检,Panel设计热点突变基因（14基因）,涵盖基因,KRAS,NRAS,BRAF,PIK3CAAKT1,CTNNB1,EGFR,ERBB2,FBXW7,GNAS,MAP2K1,SMAD4,TP53,APC,14,2016ThermoFisherScientificCorporation.Allrightsreserved.,不同分子亚型乳腺癌的辅助治疗方案选择,15,2016ThermoFisherScientificCorporation.Allrightsreserved.,OncomineBreastcfDNAAssay：乳腺癌突变和CNV液体活检,cfDNA,IonTorrentOncomineBreastcfDNAResearchAssayv2(单管检测),AKT1CCND1EGFRERBB2,ERBB3ESR1FBXW7FGFR1,KRASPIK3CASF3B1TP53,12,76,10,152,16,2016ThermoFisherScientificCorporation.Allrightsreserved.,Genes,Amplicons,Geneswithkeyhotspotmutations,HotspotSNVsandindels,SNVLODdownto0.1%with20nginputsamesensitivityandspecificityCNVsCCND1,ERBB2,FGFR1detectfoldchangeof1.21.4xTP53Morecompletecoverage;0.5%LODondenovosequencing,OncominePan-CancerCell-FreeAssay：泛癌种液体活检,适用多癌种,ForResearchUseonly.Notforuseindiagnosticprocedures.2016ThermoFisherScientificCorporation.Allrightsreserved.,17,ForResearchUseOnly.Notforuseindiagnosticprocedures,Bladder（膀胱癌）BrainandCNS（脑癌）Breast（乳腺癌）Cervical（颈椎）Colorectal（结直肠癌）Endometrial（子宫内膜癌）Esophageal（食道癌）Gastric（胃癌）HeadandNeck（头颈癌）Kidney（肾癌）Liver（肝癌）Lung（肺癌）Melanoma（黑色素瘤）Ovarian（卵巢癌）Pancreatic（胰腺癌）Prostate（前列腺癌）Sarcoma（肉瘤）Thyroid（甲状腺癌）,精心选择的基因列表为更多患者提供精准治疗的可能,如何选择靶基因？OncominePan-CancerCell-FreeAssay,ForResearchUseonly.Notforuseindiagnosticprocedures.2016ThermoFisherScientificCorporation.Allrightsreserved.,18,ForResearchUseOnly.Notforuseindiagnosticprocedures,试剂盒效能：使用标准品检测灵敏度和特异性,ngofinputcfDNA,Minimumcoverage,HighSensitivityandSpecificity,0.1%LimitofDetection,19,2016ThermoFisherScientificCorporation.Allrightsreserved.,ForResearchUseOnly.Notforuseindiagnosticprocedures,1ngcfDNA0.6%LOD5ngcfDNA0.25%LOD10ngcfDNA0.15%LOD20ngcfDNA0.1%LOD30ngcfDNA0.05%LOD,效能如何？,20,高通量测序方案：按需选择合适的IonS5TM芯片,Ion540Chip6080Mreads,Ion530Chip1520Mreads,OncomineLungcfTNAAssay,6-plex,24-plex,OncomineBreastcfDNAAssayv2,5-plex,20-plex,OncomineColoncfDNAAssay,6-plex,24-plex,OncominePan-CancerCell-FreeAssay1-plex4-plex*Thecontentprovidedhereinmayrelatetoproductsthathavenotbeenofficiallyreleasedandissubjecttochangewithoutnotice.2016ThermoFisherScientificCorporation.Allrightsreserved.,8-plex,Ion550Chip100130Mreads,需要多大通量的仪器？,21,基于IonReporter服务器的数据过滤流程,280,totalvariantstoexamine,8,totalfusionsdetected,2,Oncominefusionsdetected,插件自动过滤数据：OncomineVariantAnnotatorplug-inannotatesandfiltersvariantstofindtherelevantfew,20F1or6RTesheearrcmhoUsFeiOshnley.rNSotcfioernutsieficinCdiaogrnpoosrtiactpiroonce.dAurlelsr.ightsreserved.,如何过滤突变信息？,软件配套：提供靶向治疗研究报告，打通最后一公里,如何出具报告？基于OncomineKnowledgebase给出汉化版靶向用药指导建议,22,2016ThermoFisherScientificCorporation.Allrightsreserved.,实验室Th成报告,OncomineKnowledgebaseReporter,快速的两日OncominecfTNAAssay流程助力临床研究需求,模板制备,测序,cfTNA分离提取MagMAXcfTNA分离提取试剂盒,IonS5andIonS5XLSystemsAlsoenabledonIonPGMandIonProtonSystems,数据分析,VariantcallerinTorrentSuiteandIonReporterSoftware,文库制备,OncominecfTNAAssays,IonChefSystem,cfTNAAssays包括文库制备和数据分析,整体实验流程需要多久时间？一管血，两日工作流程(32hours)实现0.1%低频突变检测，单管检测突变、融合及CNV轻松导出突变及相关用药指导信息,23,2016ThermoFisherScientificCorporation.Allrightsreserved.,24,2016ThermoFisherScientificCorporation.Allrightsreserved.,全方位的实体肿瘤精准医疗支持方案让癌症临床研究更精准,适用FF/FFPE/胸腹水等,OncomineComprehensiveAssay:143genes泛癌种靶向治疗研究，用于美国NCI-MATCH临床试验,OncomineFocusAssay:52genes：泛癌种靶向治疗研究，Dx版本获得FDA批准上市,OncomineOncomineSolidTumorKits：肺癌&结直肠癌靶向治疗研究,OncomineBRCAResearchAssay:卵巢癌&乳腺癌易感检测及PARP抑制剂靶向治疗研究,OncomineImmuneResponseResearchAssay:寻找免疫治疗bio-markers,AmpliSeqImmuneRepertoireAssayPlus,TCRbeta：免疫治疗研究,OncomineTumorMutationLoadAssay:免疫治疗研究,MSI检测(CE平台):免疫治疗用药指导,OncomineLungcfTNAAssay：肺癌靶向治疗研究,OncomineColoncfDNAAssays：结直肠癌靶向治疗研究,On