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What is Precision Medicine? Comprehensive genomic profiling
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FoundationOne® offers comprehensive genomic profiling

Our approach

Our approach is designed to improve operation efficiency when compared with multiple, narrower tests1

The Roche Foundation Medicine platform leverages NGS technology to examine regions of the tumour genome, which common diagnostic techniques such as PCR/IHC/FISH, and multigene hotspot NGS tests may miss.2–11 CGP detects the four main classes of genomic alterations – base substitutions, insertions or deletions, copy number alterations and gene rearrangements – in a comprehensive set of over 300 cancer‑relevant genes, and reports TMB and MSI.*2,6,7,12,13–16

How is CGP different to existing diagnostic tests?

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
Clear in-depth reports

The FoundationOne® report provides clear, detailed information to support treatment decision-making†17

Our clear, detailed report supports clinical decision-making by providing insights into the patient’s genomic profile and using these to inform the use of immunotherapies, identify alternative therapy options and identify trial opportunities. The FoundationOne® CDx report may also highlight important disease-relevant genes that have no alterations but are particularly relevant for the specific tumour type,17 and identify European Medicines Agency (EMA)‑validated therapies,17† which have been assessed and authorised before being made available to patients.18

Detailed patient profile reports17

Gene alterationsClinically relevant alterations inanalysed cancer-related genes Genomic signaturesTMB and MSI status* used to inform immunotherapy treatment decisions Clinical trialsRelevant trials that your patient may beeligible for, based on their genomicprofile and geographical location Therapies with clinical benefitApproved targeted therapies andimmunotherapies that your patient may be eligible for, based on the biology of the individual tumour 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 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 Drug Name Drug Name Drug Name Drug Name Drug Name Drug Name Drug Name Drug Name 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 3 3 4 2 1 4 2 1 Report provided for demonstration purposes only. The biology of individual tumours may lead to no drugs being identified within the report; results are dependent on the patient's individual genomic profile.
REPORTWITHAPPROVEDTHERAPIES

View a sample report:

FoundationOne CDx FoundationOne CDx
FoundationOne Liquid CDx FoundationOne Liquid CDx

Validation

Quality and validation of evidence with FoundationOne® CDx aims to provide service confidence

FoundationOne® CDx has been approved as a companion diagnostic by the FDA for 17 different therapies, as well as featuring in over 250 publications in peer-reviewed journals.19,20 This level of validation should provide confidence that the information you are acting upon is well-informed, accurate and reliable.

 

All services are analytically and clinically validated

All testing procedures should be validated prior to being introduced into routine clinical care. Analytical validation is the ability to detect and measure the presence of a specific biomarker of interest with high sensitivity, accuracy and robustness.21–23 Clinical validation is the ability to divide one population into two or more groups on the basis of outcomes, such as treatment response.21–23

Based on our analytically and clinically v alid a t ed pl a t f orm ‡2 – 7 Validation published in alid a tion published in Plos One Sept 2020 11

View validation:

FoundationOne CDx FoundationOne CDx
FoundationOne Liquid CDx FoundationOne Liquid CDx

*TMB and MSI reported in FoundationOne® CDx and FoundationOne® Liquid CDx.

†Therapies contained in the report may have been approved through a centralised EU procedure or a national procedure in an EU Member State.

‡ Analytical validation based on demonstrated concordance with the following companion diagnostics: cobas® EGFR Mutation Test, Ventana ALK (D5F3) CDx Assay, Vysis ALK Break-Apart FISH Probe Kit, therascreen® KRAS RGQ PCR Kit, Dako HER2 FISH PharmDx® Kit, cobas® BRAF V600 Mutation Test, THxID® BRAF kit.

For more information, please see the FoundationOne® CDx Technical Specifications [Hyperlink to CDx Tech Specs] and the FoundationOne® Liquid CDx  Technical Specifications [Hyperlink to Liquid Tech Specs].

CGP: comprehensive genomic profiling; EMA: European Medicines Agency; FISH: fluorescence in situ hybridisation; IHC: immunohistochemistry; MAF: mutant allele fraction; MSI: microsatellite instability; NCCN: National Comprehensive Cancer Network; NGS: next-generation sequencing; NHS: National Health Service; PCR: polymerase chain reaction; TMB: tumour mutational burden.

M-GB-00001593 September 2020

References

  1. Munoz J, et al. Am Soc Oncol Educ Book. 2013;127–134.
  2. Frampton GM, et al. Nat Biotechnol. 2013;31:1023–1031.
  3. Drilon A, et al. Clin Cancer Res. 2015;21:3631–3639.
  4. Rankin A, et al. Oncologist. 2016;21:1306–1314.
  5. Ross JS, et al. Cancer. 2016;122:2654–2662.
  6. Suh JH, et al. Oncologist. 2016;21:684–691.
  7. Hirshfield KM, et al. Oncologist. 2016;21:1315–1325.
  8. Schrock AB, et al. Clin Cancer Res. 2016;22:3281–3285.
  9. He J, et al. Blood. 2016;127:3004–3014.
  10. Rozenblum AB, et al. J Thorac Oncol. 2017;12:258–268.
  11. Woodhouse R et al. Plos One Sept 2020.
  12. Cheng DT, et al. J Mol Diagn. 2015;17:251–264.
  13. Le DT, et al. N Engl J Med. 2015;372:2509–2520.
  14. Rizvi NA, et al. Science. 2015;348:124–128.
  15. Chalmers ZR, et al. Genome Med. 2017;9:34.
  16. Hall MJ, et al. J Clin Oncol. 2016;30(15_suppl):1523.
  17. FoundationOne Liquid CDx Technical Specifications M-GB-00000169 September 2020
  18. European Medicines Agency. Authorisation of medicines. 2017. Available at: https://www.ema.europa.eu/en/about-us/what-we-do/authorisation-medicines
  19. 503 results, as of July 2020. Available at: https://pubmed.ncbi.nlm.nih.gov/?term=%22Foundation+Medicine%22+%5BAffiliation%5D
  20. Food and Drug Administration. Approved medical devices: FoundationOne® CDx. Available at: https://www.fda.gov/medical-devices/recently-approved-devices/foundationone-cdx-p170019
  21. Merker JD, et al. J Clin Oncol. 2018;36:1631–1641.
  22. Scheerens H, et al. Clin Transl Sci. 2017;10:84–92.
  23. Masucci GV, et al. J Immunother Cancer. 2016;4:76.