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2018
ABloodTestforRiskStratificationofIndeterminatePulmonaryNodules
Aidsinrisk stratificationofpulmonary nodulesEarlyCDT®-Lung
AsimplebloodtestthatcomplementsCT scans
Measuresapanelof7autoantibodiesassociatedwithalltypes/stagesoflung cancer
Strongclinicaldatademonstratinghighspecificityand PPV
Determinesmalignancy riskofindeterminatenodulesbeyondcurrentrecommendedrisk calculators
Mayrecategorizenodulestointerventionriskallowingearlierinterventionandbetter outcomes
HealeyGF,etal.JCancerTher. 2017;8:506-517.MassionPP,etal.JThoracOncol. 2017;12(3):578-584.HealeyGF,etal.JThorac Dis.2013;5(5):618-625.
WhatisEarlyCDT®-Lung?
PerformanceofEarlyCDT®-LungForPulmonaryNodulePopulation
HealeyGF,etal.JCancerTher. 2017;8:506-517.MassionPP,etal.JThoracOncol. 2017;12(3):578-584.
HealeyGF,etal.JThorac Dis.2013;5(5):618-625.NationalLungScreeningTrialResearchTeam,etal.,NEngl JMed. 2013;368(21):1980-91.
PPVbasedon20%lungcancerprevalence.
<10%riskoflung cancer*
HighorModerateEarlyCDT-Lung testresult -> riskraisedtoIntermediate risk
10-65%risk oflung cancer*
High EarlyCDT-Lung testresultraisesrisktoInterventionrisk forallpatients.Moderate EarlyCDT-Lungtestresult>25%increaseinrisk,soInterventionrisk forsomepatients.
>65%riskoflung cancer*
OccasionaluseofEarlyCDT-Lungfollowingbiopsyorbronchoscopywhereitisdeemedfurtherriskevaluationisof value.
INTERMEDIATERISK
INTERVENTIONRISK
LOWRISK
1.ApplytheSwensen/Mayo noduleriskcalculatorasrecommendedinACCP guidelines
2.TakeasampleofbloodfortheEarlyCDT-Lungandgetpatient’srevisedmalignancyrisk viaadetailedtestreport.Determineclinicalfollowupaccordingtoguidelinesforthatlevelofrisk.
Swensen SJ,etal.ArchInternMed. 1997;157:849-855.HealeyGF,etal.JCancerTher. 2017;8:506-517.Massion PP,etal.JThorac Oncol. 2017;12(3):578-584.
*RiskcategoriesaccordingtotheACCPguidelines
RiskStratificationofPatientswithIndeterminatePulmonaryNodules
Swensen/Mayorisklevel RiskadjustedbyEarlyCDT-Lungtestresults
Massion PP,HealeyGF,PeekLJ,etal.JThorac Oncol.2017;12(3):578-584HealeyGF,MacdonaldIK,ReynoldsC,etal.JCancerTher.2017;8:506-517.
EarlyCDT®-LungfitsinwithACCPguidelinesbyhelpingtoassesstheprobabilityofmalignancyofanodule
“Moderate”or“High”Level• Indicatesthatapatient’sriskof
havinglungcancer issignificantlygreaterthanthatpredictedbytheirgender,age,smokinghistory,nodulecharacteristicsandotherriskfactors
“NoSignificantLevelofAutoantibodies Detected”• Patient’sriskoflungcancer
doesnotchangefromthecalculated risk
• Addsconfidenceinpreviouslyselectedtreatmentpathway
• Patientexperienceslessanxietyifnextstepsarewatchfulwaiting
Completeinformationata glance:
EarlyCDT®-LungEasy-To-ReadTestResults
SummaryInformation Individual
autoantibodyresults
Linktoriskcalculator
CommentsfromLaboratoryDirector
Detailedbreakdownofcutofflevelsandfurthereducationonresultsforpatients
AutoantibodyCut-offs
§ EachAutoantibody(Aab)has2cut-offs:amoderateandahighcut-off
§ Positiveresults:• If1ormoreAAb isabovetheHighcut-offà HighLevelresult
• If1ormoreAAb isabovetheModeratecut-offandnoneareabovethehighcut-offàModerateLevelresult
§ IfallAAbs arebelowtheModeratecut-offà NoSignificantLevelofAutoantibodiesDetectedresult
§ Cut-offswereoptimizedforeachAAb tomaximizespecificityofthe7-AAbpanelincase-controlstudiesusinghighrisksubjects• Specificity@HighLevel=98%• Specificity@ModerateLevel=93%
NoSignificantLevelof
AutoantibodiesDetected
ModerateLevel
HighLevel
Autoantib
odyLevel
HighCut-off
ModerateCut-off
*GouldMK,etal.Chest2013;143(5):e93S-e120S.
EarlyCDT®-Lung PublicationsforRiskAssessmentofPulmonaryNodules
EarlyCDT-LungsignificantlyincreasesthePPVofCTscanningandofnodule-basedriskcalculators1
§ EarlyCDT-Lungusedincombinationwiththeinitialassessmentofnoduleprobabilityofmalignancyprovidesinvaluableadditionaldata:• Mayleadtoearlierintervention,and• Betterpatientoutcomes
§ TheSwensen/MayoriskcalculatortocalculatethemalignancyriskofanodulewiththeaddedvalueofEarlyCDT-Lungisavailableviaourwebsite,orourmobileApp
Massion P.,HealeyG.,etal:AutoantibodySignatureEnhancesthePositivePredictivePowerofComputedTomographyandNodule-basedRiskModelsforDetectionofLungCancerJThorac Oncol.2017March;12(3):578-584/j.tho.2016.08.143
OureasytouseRiskCalculatorAppisavailableforAndroidandiOSandonourwebsite
EarlyCDT-LungforNodulesApp
§ FortheAppsimplysearchforEarlyCDT orOncimmune
§ ForAndroid:https://play.google.com/store/apps/details?id=com.oncimmune§ ForApple:https://itunes.apple.com/gb/app/earlycdt-lung-for-nodules/id1310399708?mt=8§ Web:§ www.oncimmune.com/
EarlyCDT®-Lung nowavailablewithasimplefingerstickblooddraw
EarlyCDT®-Lungnowavailablewithfingerstickblooddrawthatthepatientcanusetogiveaspecimen
Itis:• simple• quick• convenient
ThespecimencollectionkitmakesEarlyCDT®-Lungsimpletoorder
• EarlyCDT®-Lung specimencollectionkitcontainseverythingneededtoorderthetestforbothfingerstickandtraditionalblooddraw
• Choosethedrawoptionthatworksbestforyouandyourpatient.
• Orderspecimencollectionkitscall1-877-745-5342oremailinfo@legacyscientific.com
