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BackgroundCRC:majorcauseofdeathanddiseaseBackgroundProcessesofcolorectalcarcinogenesislendthemselvestoscreeningBackgroundAsubstantialproportionnevertested!ScreeningforCRCiscost-effectiveAsimple,noninvasivetestmightimproveclinicalout-comes28%BackgroundColorectalcancerarisesfromaccumulatedgeneticandepigeneticalterationsAimEvaluatethemultitargetstoolDNAtestasatoolforscreeningAimPrimaryaim:DNAtestinthedetectionofCRCSecondaryaims:DNAtestinthedetectionofadvancedprecancerouslesionsandtocompareitwithacommerciallyavailablefecalimmunochemicaltest(FIT)DNAtestVSMethodsStudyPopulation:2011.6-2012.1190sites

AsymptomaticpersonsAgesof50to84ataverageriskforCRCScheduledtoundergoscreeningcolonoscopySecondaryaims:DNAtestinthedetectionofadvancedprecancerouslesionsandtocompareitwithacommerciallyavailablefecalimmunochemicaltest(FIT)Asimple,noninvasivetestmightimproveclinicalout-comesAsubstantialproportionnevertested!digestivecancer,orinflammatoryboweldiseasepreviouscolonoscopy,bariumenema,CT,sigmoidoscopyundergonecolorectalresectionAdvancedprecancerouslesions:Advancedadenomashigh-gradedysplasiafamilyhistorySessileserratedpolypsmeasuring1cmormoreindiameterundergonecolorectalresectionStudyPopulation:Agesof50to84ataverageriskforCRCpreviouscolonoscopy,bariumenema,CT,sigmoidoscopyConclusionsSessileserratedpolypsmeasuring1cmormoreindiameterCRC,stagedeterminedwiththeuseoftheAJCCstagingsystempositiveresultsonfecalbloodtesting,rectalbleedingSecondaryaims:DNAtestinthedetectionofadvancedprecancerouslesionsandtocompareitwithacommerciallyavailablefecalimmunochemicaltest(FIT)CRC,stagedeterminedwiththeuseoftheAJCCstagingsystemMethodsExcluded

personalhistory:colorectalneoplasia,digestivecancer,orinflammatoryboweldisease

previouscolonoscopy,bariumenema,CT,sigmoidoscopy

positiveresultsonfecalbloodtesting,rectalbleedingundergonecolorectalresectionfamilyhistoryMethodsPrimaryandSecondaryOutcomesCRC,stagedeterminedwiththeuseoftheAJCCstagingsystem

Advancedprecancerouslesions:

Advancedadenomashigh-gradedysplasiawith≥25%villoushistologicfeaturesmeasure≥1cminthegreatestdimension

Sessileserratedpolypsmeasuring1cmormoreindiameteraberrantlymethylatedBMP3andNDRG4promoterregionsmutantKRASimmunochemicalassayforhumanhemoglobinFITMultitargetstoolDNAtestResults127760.7%7.6%ResultsResultsResultsFigure3.ReceiverOperatingCharacteristic(ROC)CurvesComparingDNATestingandFITfortheDetectionofColorectalCancerandAdvancedColorectalNeoplasia.ResultsMultitargetDNAtestingdetectedclinicallysignificantlesionsmoreefficientlythanFIT.ConclusionsAstooltestcombiningalteredhumanDNAandfecalhemoglobinshowedhighersensitivitythanacommercialFITforbothCRCandadvancedprecancerouslesions,althoughwithlowerspecificity.TranslationalResearchAug.12,2014FDAApprovesCologuardFirstandOnlyStoolDNANoninvasiveColorectalCancerScreeningTestReceivedaproposedcove-ragememorandumfromtheCentersforMedicareandMedicaidServices(CMS)ProcessesofcolorectalcarcinogenesislendthemselvestoscreeningAdvancedprecancerouslesions:CRC,stagedeterminedwiththeuseoftheAJCCstagingsystem1190sitesundergonecolorectalresectionAdvancedprecancerouslesions:familyhistoryAstooltestcombiningalteredhumanDNAandfecalhemoglobinshowedhighersensitivitythanacommercialFITforbothCRCandadvancedprecancerouslesions,althoughwithlowerspecificity.positiveresultsonfecalbloodtesting,rectalbleedingpositiveresultsonfecalbloodtesting,rectalbleedingMultitargetstoolDNAtestMultitargetDNAtestingdetectedclinicallysignificantlesionsmoreefficientlythanFIT.Aneasy-to-usescreen-ingtestEvaluatethemultitargetstoolDNAtestasatoolforscreeningColorectalcancerarisesfromaccumulatedgeneticandepigeneticalterationsCRC,stagedeterminedwiththeuseoftheAJCCstagingsystempositiveresultsonfecalbloodtesting,rectalbleedingAsymptomaticpersonsAdvancedadenomashigh-gradedysplasiaColorectalcancerarisesfromaccumulatedgeneticandepigeneticalterationsStudyPopulation:PeopleataverageriskforcolorectalcancerAneasy-to-usescreen-ingtest599$BackgroundAsubstantialproportionnevertested!ScreeningforCRCiscost-effectiveAsimple,noninvasivetestmightimproveclinicalout-comes28%MethodsStudyPopulation:2011.6-2012.1190sites

AsymptomaticpersonsAgesof50to84ataverageriskforCRCScheduledtoundergoscreeningcolonoscopyMethodsPrimaryandSecondaryOutcomesCRC,stagedeterminedwiththeuseoftheAJCCstagingsystem

Advancedprecancerouslesions:

Advancedadenomashigh-gradedysplasiawith≥25%villoushistologicfeaturesmeasure≥1cminthegreatestdimension

Sessileserratedpolypsmeasuring1cmormoreindiameterResultsFigure3.ReceiverOperatingCharacteristic(ROC)CurvesComparingDNATestingandFITfortheDetectionofColorectalCancerandAdvancedColorectalNeoplasia.ConclusionsAstooltestcombiningalteredhumanDNAandfecalhemoglobinshowedhighersensitivitythanacommercialFITforbothCRCandadvancedprecancerouslesions,althoughwithlowerspecificity.1190sitesAstooltestcombiningalteredhumanDNAandfecalhemoglobinshowedhighersensitivitythanacommercialFITforbothCRCandadvancedprecancerouslesions,althoughwithlowerspecificity.CRC,stagedeterminedwiththeuseoftheAJCCstagingsystemAsymptomaticpersonspositiveresultsonfecalbloodtesting,rectalbleedingdigestivecancer,orinflammatoryboweldiseaseAgesof50to84ataverageriskforCRCpreviouscolonoscopy,bariumenema,CT,sigmoidoscopyPrimaryandSecondaryOutcomesmeasure≥1cminthegreatestdimensionAdvancedadenomashigh-gradedysplasiaSessileserratedpolypsmeasuring1cmormoreindiameterCRC,stagedeterminedwiththeuseoftheAJCCstagingsystemFDAApprovesCologuardSecondaryaims:DNAtestinthedetectionofadvancedprecancerouslesionsandtocompareitwithacommerciallyavailablefecalimmunochemicaltest(FIT)Asimple,noninvasivetestmightimproveclinicalout-comespositiveresultsonfecalbloodtesting,rectalbleedingpositiveresultsonfecalbloodtesting,rectalbleedingPrimaryandSecondaryOutcomesScheduledtoundergoscreeningcolonoscopyAdvancedprecancerouslesions:ReceiverOperatingCharacteristic(ROC)CurvesComparingDNATestingandFITfortheDetectionofColorectalCancerandAdvancedColorectalNeoplasia.undergonecolorectalresectionAdvancedadenomashigh-gradedysplasiaMultitargetDNAtestingdetectedclinicallysignificantlesionsmoreefficientlythanFIT.undergonecolorectalresectionAsubstantialproportionnevertested!CRC,stagedeterminedwiththeuseoftheAJCCstagingsystemFDAApprovesCologuardCRC,stagedeterminedwiththeuseoftheAJCCstagingsystemCRC,stagedeterminedwiththeuseoftheAJCCstagingsystemCRC,stagedeterminedwiththeuseoftheAJCCstagingsystemwith≥25%villoushistologicfeaturesCRC,stagedeterminedwiththeuseoftheAJCCstagingsystemFirstandOnlyStoolDNANoninvasiveColorectalCancerScreeningTestSecondaryaims:DNAtestinthedetectionofadvancedprecancerouslesionsandtocompareitwithacommerciallyavailablefecalimmunochemicaltest(FIT)Sessileserratedpolypsmeasuring1cmormoreindiameterConclusionsdigestivecancer,orinflammatoryboweldiseasepersonalhistory:colorectalneoplasia,Advancedprecancerouslesions:Colorectalcancerarisesfromaccumulatedgeneticandepigeneticalterationspreviouscolonoscopy,bariumenema,CT,sigmoidoscopyPrimaryaim:DNAtestinthedetectionofCRCEvaluatethemultitargetstoolDNAtestasatoolforscreeningCRC,stagedeterminedwiththeuseoftheAJCCstagingsystempreviouscolonoscopy,bariumenema,CT,sigmoidoscopyPrimaryandSecondaryOutcomesAsymptomaticpersonsMultitargetDNAtestingdetectedclinicallysignificantlesionsmoreefficientlythanFIT.positiveresultsonfecalbloodtesting,rectalbleedingMultitargetstoolDNAtestpositiveresultsonfecalbloodtesting,rectalbleedingAsymptomaticpersonsfamilyhistoryAsubstantialproportionnevertested!Advancedprecancerouslesions:Processesofcolorectalcarcinogenesislendthemselvestoscreeningpositiveresultsonfecalbloodtesting,rectalbleedingPrimaryandSecondaryOutcomesMultitargetDNAtestingdetectedclinicallysignificantlesionsmoreefficientlythanFIT.Advancedprecancerouslesions:Advancedprecancerouslesions:measure≥1cminthegreatestdimensionAdvanc

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