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Our extensively validated, tissue-based comprehensive genomic profiling service for all solid tumours that helps guide efficient, personalised treatment decisions.1,2

Extensively validated Based on our analytically and clinically validated, FDA-approved comprehensive platform† 1,5 A single, tissue- and time-saving test Delivers all insights at once in a single test, thus saving tissue and time versus sequential biomarker testing 3,4,7 Opens possibilities Potentially expands your patient’s treatment options ‡4,7–11 Provides insights that can help support treatment decisions and may improve clinical outcomes ‡12–15 Supports clinical decision-making Clear, in-depth report provides insights on the genomic profile of your patient as well as associated targeted therapies, immunotherapies and relevant clinical trials 6 324 genes, TMB and MSI Assesses the four main classes of genomic alterations* in 324 cancer-relevant genes and reports TMB and MSI 3,4
Genes and biomarkers

Comprehensive assessment in a single test

FoundationOne CDx comprehensively examines the tumour genome, assessing the four main classes of genomic alteration in 324 known cancer-relevant genes, while also reporting TMB and MSI, which can help inform the use of immunotherapies.3,4
MSI TMB Base substitutions Insertions and deletions Copy number alterations Tumour mutationalburden Microsatellite instability Rearrangements Analyses324known cancer-relevant genes

Validation

Based on FDA-approved comprehensive platform

FoundationOne CDx is based on our analytically and clinically validated, FDA-approved comprehensive platform.1,5 You can be confident in the insights generated by FoundationOne CDx thanks to the review and approval of the workflow by the FDA, including analytical and clinical validation, and bioinformatics.3

Review and approval of the FoundationOne CDx platform workflow by the FDA

Analytical validation Clinical validation Bioinformatics




What is the difference between analytical and clinical validation?

What does it mean? Analytical validation Clinical validation Ability to detect and measure the presence of a biomarker of interest accurately, reproducibly and reliably 16,17 Ability to divide one population into two or more groups on the basis of outcomes, such as treatment response 16,17 Example for FoundationOne CDx for EGFR gene in NSCLC Analytically validated to identify alterations across the entire coding region of EGFR 3 Clinically validated to identify specific alterations and approved therapies, e.g. to identify patients for whom EGFR   TKIs are indicated 1,3
In-depth report

Supports clinical decision-making

A clear, in-depth report provides insights on your patient’s genomic profile as well as associated targeted therapies, immunotherapies and relevant clinical trials. 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.6

F o u n d a t i o nO n C Dx is a n e xt- g e n e r a t i o n s e q ue n ci n g ( N GS) ba s e d a s s a y t h a t i d e n t i es g e n o m i c fi n di n g s w i t hin h u n d r e ds o f ca n c e r - r e l a t e d g e n e s . ABOUT THE TE S T X X XX X XX X QRF # 0 1 Jan 2 0 18 RE P O R T D A T E Lung adenoca r cinoma TU M OR TYP E Sample, Jane P A TIE N T P A TIENT SEX F emale MEDICAL R E C ORD # Not Gi v en D A TE OF BI R TH Not Gi v en DISEASE Lung adenoca r cinoma NAME Not Gi v en PH Y SICIAN ORDERING PHYSICIAN Not Given PATHOLOGIST Not Given MEDICAL FACILITY ID Not Given MEDICAL FACILITY Not Given ADDITIONAL RECIPIENT Not Given SP E CIMEN SPECIMEN SITE Not Given DATE OF COLLECTION Not Given SPECIMEN RECEIVED Not Given SPECIMEN ID Not Given SPECIMEN TYPE Not Given Ele c t r onically Signed b y Julia A . Elvin, M. D ., Ph. D . • J e ff r e y S . R o s s, M. D ., Medical Di r e c t or • 30 N o v ember 2 0 17 F ound a tion Medicine, Inc. • 1-888 - 9 88 - 3 6 39 S ample P r e p a r a tion: 150 Se c ond S t., 1 s t F loo r , Cambrid g e, MA 0 2 1 4 1 • CLIA: 2 2D2 0 2 7 5 31 S ample Anal y sis: 150 Se c ond S t., 1 s t F loo r , Cambrid g e, MA 0 2 1 4 1 • CLIA: 2 2D2 0 2 7 5 31 o f P A GE G e n o m i c F i n di n g s B i o ma r k e r F i n di n g s Tumor Mutational Burden - TMB-Intermediate (11 Muts/Mb) Microsatellite status - MS-Stable 7 Disease relevant genes with no reportable alterations: KRAS, ALK, BRAF, MET, RET, ERBB2, ROS1 EGFR amplification, L858R PTCH1 T416S CDKN2A/B loss RBM10 Q494* TP53 R267P F o r a c o m p l e t e li s t o f t h e g e n e s a s s a y e d , p l e a s e r e f e r t o t h e A p p e n di x . see p . 1 7 5 Trials THERAPIES WITH CLINICAL BENEFIT (IN OTHER TUMOR TYPE) THERAPIES WITH CLINICAL BENEFIT (IN PATIENT’S TUMOR TYPE) GE N OMIC F I N DI N G S amplification, L858R E GFR T 4 16S P T CH1 Erlotinib Afatinib Atezolizumab Avelumab Nivolumab Durvalumab Pembrolizumab None Gefitinib Osimertinib Cetuximab Sonidegib Lapatinib Vismodegib Panitumumab see p . 1 6 4 Trials see p . 1 4 9 Trials T MB-In t ermedia t e (11 Muts / M b ) T umor Mutational Bu r den THERAPIES WITH CLINICAL BENEFIT (IN OTHER TUMOR TYPE) THERAPIES WITH CLINICAL BENEFIT (IN PATIENT’S TUMOR TYPE) BIOMAR K E R FI N DI N G S No therapies or clinical trials. MS - Stable Mic r osa t elli t e status see B io m ar k er F in d ings sectio n C linical T rials 18 T he r apies with Lack of R esponse 0 T he r apies with C linical Benefit 14 F o u n d a t i o nO n C Dx is a n e xt- g e n e r a t i o n s e q ue n ci n g ( N GS) ba s e d a s s a y t h a t i d e n t i es g e n o m i c fi n di n g s w i t hin h u n d r e ds o f ca n c e r - r e l a t e d g e n e s . ABOUT THE TE S T X X XX X XX X QRF # 0 1 Jan 2 0 18 RE P O R T D A T E Lung adenoca r cinoma TU M OR TYP E Sample, Jane P A TIE N T P A TIENT SEX F emale MEDICAL R E C ORD # Not Gi v en D A TE OF BI R TH Not Gi v en DISEASE Lung adenoca r cinoma NAME Not Gi v en PH Y SICIAN ORDERING PHYSICIAN Not Given PATHOLOGIST Not Given MEDICAL FACILITY ID Not Given MEDICAL FACILITY Not Given ADDITIONAL RECIPIENT Not Given SP E CIMEN SPECIMEN SITE Not Given DATE OF COLLECTION Not Given SPECIMEN RECEIVED Not Given SPECIMEN ID Not Given SPECIMEN TYPE Not Given Ele c t r onically Signed b y Julia A . Elvin, M. D ., Ph. D . • J e ff r e y S . R o s s, M. D ., Medical Di r e c t or • 30 N o v ember 2 0 17 F ound a tion Medicine, Inc. • 1-888 - 9 88 - 3 6 39 S ample P r e p a r a tion: 150 Se c ond S t., 1 s t F loo r , Cambrid g e, MA 0 2 1 4 1 • CLIA: 2 2D2 0 2 7 5 31 S ample Anal y sis: 150 Se c ond S t., 1 s t F loo r , Cambrid g e, MA 0 2 1 4 1 • CLIA: 2 2D2 0 2 7 5 31 o f P A GE G e n o m i c F i n di n g s B i o ma r k e r F i n di n g s Tumor Mutational Burden - TMB-Intermediate (11 Muts/Mb) Microsatellite status - MS-Stable 7 Disease relevant genes with no reportable alterations: KRAS, ALK, BRAF, MET, RET, ERBB2, ROS1 EGFR amplification, L858R PTCH1 T416S CDKN2A/B loss RBM10 Q494* TP53 R267P F o r a c o m p l e t e li s t o f t h e g e n e s a s s a y e d , p l e a s e r e f e r t o t h e A p p e n di x . see p . 1 7 5 Trials THERAPIES WITH CLINICAL BENEFIT (IN OTHER TUMOR TYPE) THERAPIES WITH CLINICAL BENEFIT (IN PATIENT’S TUMOR TYPE) GE N OMIC F I N DI N G S amplification, L858R E GFR T 4 16S P T CH1 Erlotinib Afatinib Atezolizumab Avelumab Nivolumab Durvalumab Pembrolizumab None Gefitinib Osimertinib Cetuximab Sonidegib Lapatinib Vismodegib Panitumumab see p . 1 6 4 Trials see p . 1 4 9 Trials T MB-In t ermedia t e (11 Muts / M b ) T umor Mutational Bu r den THERAPIES WITH CLINICAL BENEFIT (IN OTHER TUMOR TYPE) THERAPIES WITH CLINICAL BENEFIT (IN PATIENT’S TUMOR TYPE) BIOMAR K E R FI N DI N G S No therapies or clinical trials. MS - Stable Mic r osa t elli t e status see B io m ar k er F in d ings sectio n C linical T rials 18 T he r apies with Lack of R esponse 0 T he r apies with C linical Benefit 14 F o r m o r e i n f o rmat i o n r e g a r d i ng bi o l o g i c al a n d c l i n i c al signi c a n c e , i n c l u d i ng p r o g n o s t i c , di a g n o s t i c , g e rml i n e , a n d p o t e ntial c h e m o se nsiti v i i m p l i c at i o n s , s e e t h e G e n o m i c F i n d i ngs s e ct i o n. GE N OMIC FI N DI N GS W ITH N O REPO R T ABLE THERAPEUTIC OR CLI N I C AL T R I A LS OPTIO N S p . 5 lo s s CDK N 2A/ B p . 5 Q 4 9 4 * R B M1 0 p . 6 R 2 6 7 P T P 5 3 Genomic al t e r a tions de t e c t ed m a y be a s s oci a t ed with a c tivi t y o f c e r tain app r o v ed the r api e s; h o w e v e r , the a g en t s li s t ed in this r epo r t m a y h a v e v aried clinical e viden c e in the p a tient s tumor t ype. T he r api e s and the clinical trials li s t ed in this r epo r t m a y n o t be c omple t e and e xhau s ti v e. Neither the the r apeutic a g en t s nor the trials identified a r e r an k ed in o r der o f p o t ential or p r edi c t ed e ffica c y f or this p a tient, nor a r e th e y r an k ed in o r der o f l e v el o f e viden c e f or this p a tient s tumor t ype. T his r epo r t should be r e g a r ded and u s ed as a supplementa r y s ou r c e o f in f orm a tion and n o t as the single basis f or the making o f a the r a p y decision. All t r e a tment decisions r emain the full and final r e sponsibili t y o f the t r e a ting p h y sician and p h y sicians should r e f er t o app r o v ed p r e s cribing in f orm a tion f or all the r api e s. N O TE T he r api e s c ontained in this r epo r t m a y h a v e been app r o v ed b y the U S F D A . X X XX X XX X QRF # 0 1 Jan 2 0 18 RE P O R T D A T E Lung adenoca r cinoma TU M OR TYP E Sample, Jane P A TIE N T 2 5 6 1 3 4 2 5 6 1 3 4 Genomic findings Clinically r el e v ant al t e r a tions in 3 2 4 t e s t ed can c er- r el a t ed genes Biomar k er findings TMB and MSI s t a tus, which m a y p r edict r esponse t o immunothe r a p y Clinical trials R el ev ant trials th a t y our p a tient m a y be eligible f o r , based on their genomic p r ofile and geog r aphical loc a tion T he r apies w i t h c lini ca l bene t App r o v ed the r apies f or y our p a tien t s biomar k ers and genomic al t e r a tions G eno m i c n ding s w i t h no r epo rta ble option s T o help y ou rule out un c ertainty and de t ermine the mo s t app r opri a t e c ourse of action P ertinent neg a ti v e r esults Rules out important al t e r a tions th a t a r e not p r esent
Novel insights

Opens up treatment possibilities

FoundationOne CDx may detect clinically relevant genomic alterations missed by other tests, thereby opening up new treatment options.‡10,18,19

Key alterations in NSCLC