200PCRCRO12PCRQPCRddPCR323andMeFDA23andMeB2C4PCRDNAPCRDNA20700201420142CFDA2014320141220151108NIPT1320153CFDA201563302400/108NIPT13CFDAEGFRKRASBRAFC-KITCYP2C9CYP2C19CFDANIPTLDTsPCRqPCRddPCRFISHPCRFISHPCRLDT3CLIA/CAPLDTCFDANIPTCFDABGISEQ-100lifeIonTorrentBGISEQ-1000CompleteGenomicsDAProtonlifeIonTorrentBioelectronSeq4000lifeIonTorrentIlluminaNextSeqCN500NIPT131821LDTspanelLTDsCFDApanelCLIA/CAPCLIACLIAClinicalLaboratoryImprovementAmendmentsLDTsFDACLIACLIAFDACLIACLIAFDAFDAFDAFDACLIADNADNADNACLIALTDsNIPTNIPT1500NIPT2400NIPT131821lifeiontorrent53iontorrentNIPTNIPT450panel82panel5IlluminaHiseq/nextSeq15ctDNACTCLiquidBiopsyNIPTNIPTDNActDNACTC4.1ctDNActDNA(circulatingtumorDNA)DNADNA(cell-freeDNAcfDNActDNADNActDNActDNActDNANGSPCRddPCRctDNAcfDNA1%DNActDNAqPCRctDNANGSddPCRddPCRqPCRctDNA1cfDNAQiagenctDNAQiagenctDNA5mLNIPTDNAcfDNA10%0.1mL2cfDNActDNAcfDNActDNActDNA70%3ctDNA2000x20000xIlluminaHiseq/NextSeqlifeionProtonIlluminaLifeIlluminaNextSeqlifeionProtonCFDActDNA1ctDNA,NGSctDNA2ddPCRqPCR3ctDNAMRD4ctDNA80%ctDNA2014IressactDNActDNActDNA4.2CTCCTCCirculatingtumorcell,CTCCTC1001mL1CTCCTCCTCCTCCTCCTCCTCCTC2007ASCOCTCCTC1CTCPCRctDNACTCCTCCTCTNMCTCCTCCTCCTCCTCCTC7.5mlCTC5,7.5mlCTC3CTCCTCCTCCTCCTCCellCullector/CTCEPISPOT,CAMCTCWGASOPQCCTCCTCCTCCTCCTC4.3DNARNARNACTCctDNA(CD9CD63Alix),pHCTCDNARNACTCNGSDNA/DNA//CFDAPCRCROFoundationMedicineFoundationMedicineFoundationMedicine10DNA14-21FoundationMedicineFoundationOneFoundationOneHemeIlluminaHiSeq2000systemLifeTechnologies'IonTorrentFoundationOne31528$5800FoundationOneHeme40531265RNA$7200FoundationOne201310NatureBiotechnologyFoundationCORE201412ICE2FoundationCOREICE2PatientMatchFoundationCOREFoundationOneFoundationOneHemePatientMatchICE22015FoundationCORE6FoundationMedicine2014FoundationMedicineGoogleDNAFoundationMedicineMcKessonZ-codeFoundationMedicineJasonRyanFoundationMedicine2015117075%137040%1CompleteGenomicsBGISEQLifeTechnologiesIronProtonBIGIS20142.548NIPTDNAPCR34%CROPVP