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A leading comprehensive genomic profiling approach

Our approach

Foundation Medicine approach broadly examines the tumour genome

The Foundation Medicine comprehensive genomic profiling approach· leverages next generation sequencing (NGS) technology to examine regions of the tumour genome that other tests miss.1-13 It detects both novel and known variants, including the four main classes of genomic alterations - base substitutions, insertions or deletions, copy number alterations and gene rearrangements - in a comprehensive set of cancer-relevant genes, and reports Tumour Mutational Burden (TMB) or blood Tumour Mutational Burden (bTMB), and Microsatellite Instability (MSl).†1-7

Multigene hotspot NGS tests

Multigene hotspot tests risk missing genomic alterations while comprehensive genomic profiling broadly analyses the genome to identify all relevant alterations

Comprehensive genomic profiling

Multigene hotspot tests risk missing genomic alterations while comprehensive genomic profiling broadly analyses the genome to identify all relevant alterations

*TMB reported by FoundationOne CDx and FoundationOne Heme. bTMB reported by FoundationOne Liquid CDx. MSI reported by FoundationOne CDx and FoundationOne Heme, MSI-H reported by FoundationOne Liquid CDx.

Clear in-depth reports

Clear, in-depth report supports clinical decision-making

Our clear, in-depth report supports clinical decision-making by providing insights on the patient's genomic profile as well as associated targeted therapies, immunotherapies and relevant clinical trials. Approved therapies are ranked alphabetically within NCCN therapy categories (for additional information on the NCCN categories please refer to the NCCN Compendium® at www.nccn.org). Reports vary according to regional differences, e.g. EU reports list EU-approved therapy options to support clinical decision-making.‡14

The report also highlights important disease-relevant genes with no reportable alterations identified and genomic alterations associated with potential resistance to therapy to help rule out potentially ineffective treatment.14

When using different Foundation Medicine services across the patient journey, consistency of the reports aids comparison of the results.

2213Genomic signaturesTMB/bTMB and MSI status†, which may help inform immunotherapy treatment decisionsClinical trialsRelevant trials that your patients may be eligible for, based on their genomic profile and geographical locationGene alterationsClinically relevant alterations in analysed cancer-related genesTherapies with clinical benefitApproved targeted therapies and immunotherapies (ranked alphabetically within NCCN therapy categories)§ for your patients gene alterations and genomic signatures1344

View a sample report:

Validation

Extensively validated and supported by clinical evidence

Our services are supported by a large and growing body of clinical evidence with over 450 publications since the founding of Foundation Medicine.15-16 The validations of Foundation Medicine's comprehensive genomic profiling services are published in top-tier peer-reviewed journals.4-7

ARTICLESDevelopmentandvalidationofaclinicalcancergenomicprofilingtestbasedonmassivelyparallelDNAsequencingGarrettM Frampton1,9,AlexFichtenholtz1,9,GeoffAOtto1,KaiWang1,SeanRDowning1,Jie He1,MichaelSchnall-Levin1,JaredWhite1,EricMSanford1,PeterAn1,JamesSun1, FrankJuhn1,KristinaBrennan1,KielIwanik1,AshleyMaillet1,JamieBuell1,EmilyWhite1,MandyZhao1,SohailBalasubramanian1,SelmiraTerzic1,TinaRichards1,VeraBanning1,LazaroGarcia1,KristenMahoney1,ZacZwirko1,AmyDonahue1,HimishaBeltran2,3,JuanMiguel Mosquera3,4,MarkARubin3,4,SnjezanaDogan5,CyrusV Hedvat5,MichaelFBerger5,LajosPusztai6,MatthiasLechner7,ChrisBoshoff7,MirnaJarosz1,ChristineVietz1,Alex Parker1,VincentAMiller1,JeffreySRoss1,8,JohnCurran1,MaureenTCronin1,PhilipJStephens1,DoronLipson1&RomanYelensky1Asmoreclinicallyrelevantcancergenesareidentified,comprehensivediagnosticapproachesareneededtomatchpatientsto© rights reserved.Validation published in Nature Biotechnology 20134(predecessor to FoundationOne CDx)
Based on our analytically and clinically validated, FDA-approved comprehensive platform¥17,18
AnalyticalValidationofaHybridCaptureeBasedNext-GenerationSequencingClinicalAssayforGenomicProlingofCell-FreeCirculatingTumorDNATravisA.Clark,*JonH.Chung,*MarkKennedy,*JasonD.Hughes,*NiruChennagiri,*DanielS.Lieber,*BernardFendler,*LaurenYoung,*MandyZhao,*MichaelCoyne,*VirginiaBreese,*GenevaYoung,*AmyDonahue,*DeanPavlick,*AlyssaTsiros,*TimothyBrennan,*ShanZhong,*TariqMughal,*MarkBailey,*JieHe,*StevenRoels,*GarrettM.Frampton,*JillM.Spoerke,yStevenGendreau,yMarkLackner,yEricaSchleifman,yEricPeters,yJeffreyS.Ross,*SirajM.Ali,*VincentA.Miller,*JeffreyP.Gregg,zPhilipJ.Stephens,*AllisonWelsh,*GeoffA.Otto,*andDoronLipson*jmd.amjpathol.orgTheJournalofMolecularDiagnostics,Vol.20,No.5,September2018Validation published inJournal of MolecularDiagnostics 20186
Based on our analytically and clinically validated, FDA-approved comprehensive platform¶5, 19
RegularArticleLYMPHOIDNEOPLASIAIntegratedgenomicDNA/RNAprolingofhematologicmalignanciesintheclinicalsettingJieHe,1,*OmarAbdel-Wahab,2,3,*MichelleK.Nahas,1,*KaiWang,1,*RaajitK.Rampal,2,3AndrewM.Intlekofer,4,5JayPatel,3AndreiKrivstov,4,6,7GarrettM.Frampton,1LaurenE.Young,1ShanZhong,1MarkBailey,1JaredR.White,1StevenRoels,1JasonDeffenbaugh,1AlexFichtenholtz,1TimothyBrennan,1MarkRosenzweig,1KimberlyPelak,1KristinaM.Knapp,6KristinaW.Brennan,1AmyL.Donahue,1GenevaYoung,1LazaroGarcia,1SelmiraT.Beckstrom,1MandyZhao,1EmilyWhite,1VeraBanning,1JamieBuell,1KielIwanik,1JeffreyS.Ross,1DeborahMorosini,1AnasYounes,5AlanM.Hanash,8ElisabethPaietta,9KathrynRoberts,10CharlesMullighan,10AhmetDogan,11ScottA.Armstrong,4,6,7TariqMughal,1,12Jo-AnneVergilio,1ElaineLabrecque,1RachelErlich,1ChristineVietz,1RomanYelensky,1PhilipJ.Stephens,1VincentA.Miller,1MarcelR.M.vandenBrink,8,13GeoffA.Otto,1DoronLipson,1andRossL.Levine2,3,61FoundationMedicine,Cambridge,MA;2LeukemiaService,DepartmentofMedicine,3HumanOncologyandPathogenesisProgram,4CancerBiologyandGeneticsProgram,5LymphomaService,DepartmentofMedicine,6LeukemiaCenter,7DepartmentofPediatrics,and8BoneMarrowTransplantService,DepartmentofMedicine,MemorialSloanKetteringCancerCenter,NewYork,NY;9DepartmentofMedicine(Oncology),