b'Partnerwith UsCDx Commercialization Phasing PlanningPre-Launch Launch Post-LaunchDevelop plan in collaboration Identify and nurture key Establish lab networkExpand lab network and with partner opinion leaders (KOLs) physician awareness after reimburement establishedShare market insights and Align CDx development studies Create physician awarenessand guidelines updatedcollective knowledge with commercialization studiesContinue to nurture KOLs Align Rx / Dx commercial Voice of customer to drive Activate KOL network to start objectives product requirements andcommercialization studies Monitor and adjust activitiescommercialization to achieve market adoptionDefine commercialization considerations Complete HEOR studies,strategy and country levelprepare HTAs, requestTransition to maintenance prioritization/timing Prepare marketing message reimbursement coverage campaignsfor PMA submissionDetermine activities requiringInitiate PR and marketing partner support campaignsExamples of FLT3 CDxPartnerships:NOVARTIS ASTELLASDAIICHI-SANKYOFLT3 CDx for RYDAPT (midostaurin)FLT3 CDx for XOSPATA (gilteritinib fumarate) FLT3 CDx for VANFLYTA(quizartinibhydrochloride)Breakthrough designation in the USA 140 international collection sites Bridging study for multiple labs in theFDA, Swissmedic & EU approval in 2017PMDA approval in Japan in 2018 USA, Europe and AsiaPMDA approval in Japan in 2019ARTG-inclusion in AUS Reimbursement approved in Japan FDA approval in USA in 2018 EU approval in 2019 LabPMM Services Catalog 2021|9'