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FoundationOne® CDx: the only FDA-approved broad companion 
diagnostic19

Summary

FoundationOne® CDx is a next-generation sequencing-based diagnostic test, which should be used to inform the use of immunotherapies, identify alternative options or identify trial opportunities.1–6

What is FoundationOne® CDx?

06_foundationOne CDx_02_what is CDx_v2 Analyticallyvalidated†Demonstrated specificity (>99%) and sensitivity (95–99%) when assessing formalin-fixed paraffin-embedded (FFPE) cancer specimens compared with current diagnostic tests 1 Potentially expands treatment optionsPotentially expands your patient’s treatment options §1–6 Informs the use of immunotherapies, identifies alternative therapy options and identifies trial opportunities §8–11 Supports clinical decision-makingExperts analyse the data and provide a clear, detailed report to summarise insights on the genomic profile of your patient, and link these to associated targeted therapies, immunotherapies and relevant clinical trials 7 324 genes,TMB and MSIAnalyses 324 known cancer-relevant genes, across the four main classes of genomic alterations, in addition to TMB and MSI 7* Detailed reportThe report provides clear, detailed information to inform treatment decision-making and may include therapies that are approved by the European Medicines Agency (EMA) for alterations identified in an individual patient’s tumour‡
Genes and biomarkers

Comprehensive assessment in a single test

FoundationOne® CDx provides a detailed analysis of the tumour genome, analysing 324 known cancer-relevant genes across the four main classes of genomic alterations, in addition to TMB and MSI, to inform treatment decision-making.1,7,12,13*

FoundationOne® CDx should be used proactively, at the first point of clinical uncertainty in any metastatic solid tumour

FoundationOne® CDx is a single tissue test suitable for most patients with malignant solid tumour cancers.7 It is most frequently used in patients with advanced, recurrent or metastatic cancers who have exhausted standard of care treatment options. A validated testing process, led by scientists and academics, produces a genomic report, typically within 14 days of receiving a suitable tumour sample. The FoundationOne® test (a prior version of FoundationOne® CDx) has been analytically validated with high sensitivity scores of 95–99% across the range of genomic alterations and a high specificity (positive predictive value >99%).1
MSI TMB Base substitutions Insertions and deletions Copy number alterations Tumour mutationalburden Microsatellite instability Rearrangements Analyses324known cancer-relevant genes
FoundationOne CDx gene list
Learn more about comprehensive genomic profiling
Validation

The Roche Foundation Medicine platform has been analytically validated

FoundationOne® CDx is based on our analytically and clinically validated comprehensive platform.1 A practical validation strategy to determine accuracy, including sensitivity and specificity, was applied to the prior FoundationOne® platform. Results demonstrated that the platform had a test sensitivity of 95–99% across alteration types and a high specificity with a positive predictive value of more than 99%. Application of the test to 2,221 clinical cases revealed clinically actionable alterations in 76% of tumours, three times the number of actionable alterations detected by existing diagnostic tests.1

 

What is the difference between analytical and clinical validation?

06_foundationOne CDx_05_analytical and clinical validation_v2 Analytical validation defines how accurately and reliably the test measures the cancer genes of interest in the patient specimen 14 Clinical validation should demonstrate how robustly and reliably the genomic profiling results compare with the clinical outcome of interest. The profiling should be able to separate a population into two or more distinct groups with different biological characteristics or clinical outcomes 14 Analytically validated to identify alterations across the entire coding region of EGFR 1,2,5,7 Clinically validated to identify specific alterations and approved therapies (e.g. to identify patients for whom EGFR tyrosine kinase inhibitors are indicated) 1,2,5,7
In-depth Report

The FoundationOne® CDx report provides a clear and concise view of the important information needed to support your clinical decision-making‡

The report gives detailed information on clinically relevant alterations across 324 cancer-relevant genes to inform the use of immunotherapies, identify alternative therapy options or identify trial opportunities.7
06_foundationOne CDx_06_foundationOne CDx sample report_v2 F o u n d a t i o nO n e® 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 fi 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 e® 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 fi 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 Genomic findings 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 DRUG NAME DRUG NAME DRUG NAME DRUG NAME DRUG NAME DRUG NAME DRUG NAME None DRUG NAME DRUG NAME DRUG NAME DRUG NAME DRUG NAME DRUG NAME DRUG NAME 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 fi 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 Genomic alterations 2 5 6 1 3 4 2 5 6 1 3 4
REPORTWITHAPPROVEDTHERAPIES
FoundationOne CDx sample report
Novel Insights

The FoundationOne® platform provides clear, detailed information to support confident clinical decision-making

FoundationOne® CDx may detect clinically relevant genomic alterations that common diagnostic techniques such as polymerase chain reaction (PCR) / immunohistochemistry (IHC) / fluorescence in situ hybridisation (FISH), and multigene hotspot next-generation sequencing tests may miss, which could help direct clinicians to treatment options not previously considered.§2,3,5,15,16
06_foundationOne CDx_07_novel insights_v2 ALK EGFR BRAF HER2 RET MET ROS1 KRAS ALK EGFR BRAF HER2 RET MET ROS1 ALK EGFR
Efficient Testing

FoundationOne® CDx is a single tissue test

The FoundationOne® CDx report delivers a complete set of results from a single test sample, thereby saving tissue.7
06_foundationOne CDx_08_efficient testing_v2