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A leading comprehensive genomic profiling approach

CGP 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 (MSI).†1–7

*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). The EU report includes therapies approved in the EU.‡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.

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
RFMI_F1LCDx launch_Blueprint EU_image 5.1 version editable A R TICLE S D e vel o pm e n t a nd v a lid at io n o f a cli n ic a l c a nc e r g e nomic profilin g t es t b ase d o n m a ssiv e ly p a r alle l DN A seq ue n c i n g G a r r e t t M F r a m p t o n 1 , 9 , A l e x F i c h t e n h o l t z 1 , 9 , G e o ff A O t t o 1 , K a i W a n g 1 , S e a n R D o w n i n g 1 , J i e H e 1 , M i c ha e l S c h n a l l - L e v i n 1 , J a r e d W h i t e 1 , E ri c M S a n f o r d 1 , P e t e r A n 1 , J a me s S u n 1 , F r a n k J u hn 1 , K r i s t ina B r e n n a n 1 , K i e l I w a n i k 1 , A s h l e y M a i l l e t 1 , J a m i e B u e l l 1 , E m i ly W h i t e 1 , M a n d y Zha o 1 , S o h a i l B a l a s u b r a m a n i a n 1 , S e lmi r a T e r z i c 1 , T ina R i c h a r ds 1 , V e r a B a nn i n g 1 , L az a r o G a r c i a 1 , K r is t e n M a h o n e y 1 , Z ac Z w ir k o 1 , A m y D o n a h u e 1 , H i mis ha B e l t r a n 2 , 3 , J u a n M ig u e l M o s q u e r a 3 , 4 , M a rk A R u b i n 3 , 4 , S n j e z a na D o g a n 5 , C y r u s V H e d v a t 5 , M i c ha e l F B e rg e r 5 , L a jo s Pus z t a i 6 , M a t t h i a s L e ch n e r 7 , C h r i s B o s h o ff 7 , Mi r na J a r o sz 1 , C h r i s t ine V i e t z 1 , A l e x P a r k e r 1 , V in c e n t A M i l l e r 1 , J e ff r e y S R o ss 1 , 8 , J o h n C u r r a n 1 , M a u r e e n T C r o n i n 1 , P h i l i p J S t e p h e ns 1 , D o r o n L i p s o n 1 & R o m a n Y e l e n s ky 1 As more clinically relevant cance r genes a re identified, comprehensive diagnostic ap proaches are nee ded to match patients to © rights reserved. Validation published in Nature Biotechnology 2013 4 (predecessor to FoundationOne CDx)
RFMI_F1LCDx launch_Blueprint EU_image 5.2 version editable Based on our analytically and clinically validated, FDA-approved comprehensive platform ¥17,18
RFMI_F1LCDx launch_Blueprint EU_image 5.3 version editable Analyti c a l V alidati o n o f a Hybrid Capture e Base d Next-G e neratio n Sequencing Clinica l Assa y fo r Genomi c Pro lin g o f Cell-Fre e Cir c ulating T um o r DN A T rav i s A . Cla r k, * Jo n H . Chung, * Mar k Kenned y , * Jaso n D . Hu g hes, * Nir u Chenn a giri, * Dan i e l S . Liebe r , * Bernar d Fendl e r , * Laur e n Y o u ng, * Mand y Zha o , * Micha e l Coy n e, * V irg i ni a Breese, * Genev a Y oung, * Am y Donahue, * Dea n Pavlic k , * A l yss a T sir o s, * T i m oth y B r ennan, * Sh a n Zhong, * T ar i q Mu g hal, * Mar k Bail e y , * Ji e He, * Steve n Roel s , * G a rret t M . Frampto n , * Jil l M . Spo e rke, y Stev e n Gendr e au, y Mar k Lackn e r , y Eric a Schl e ifman, y Eri c Peters, y Je f fr e y S . Ross, * Sira j M . Ali, * V inc e n t A . Mille r , * Je f fre y P . Gregg, z Phili p J . Stephens, * Alliso n W el s h, * Geo f f A . Otto, * an d Doro n Lipson * jmd.amjpa t hol.org Th e Journa l o f Molecula r Diagnostics , V ol . 20 , No . 5 , Septembe r 2018 Validation published in Journal of Molecular Diagnostics 2018 6
RFMI_F1LCDx launch_Blueprint EU_image 5.4 version editable Based on our analytically and clinically validated, FDA-approved comprehensive platform ¶5, 19
RFMI_F1LCDx launch_Blueprint EU_image 5.5 version editable Regula r Article L YMPH O I D NEOPLASI A Integrate d genomi c DNA/RN A pro lin g o f hematologi c malignancie s in th e clinica l setting Ji e He, 1, * Oma r Abdel- W ahab, 2,3, * Michell e K . Nahas, 1, * Ka i W ang, 1, * Raaji t K . Rampal, 2,3 Andre w M . Intlekofe r , 4,5 Ja y Patel, 3 Andre i Krivsto v , 4,6,7 Garret t M . Frampton, 1 Laure n E . Y oung, 1 Sha n Zhong, 1 Mar k Baile y , 1 Jare d R . White, 1 Steve n Roels, 1 Jaso n De f fenbaugh, 1 Ale x Fichtenholtz, 1 T imoth y Brennan, 1 Mar k Rosenzweig, 1 Kimberl y Pelak, 1 Kristin a M . Knapp, 6 Kristin a W . Brennan, 1 Am y L . Donahue, 1 Genev a Y oung, 1 Lazar o Garcia, 1 Selmir a T . Beckstrom, 1 Mand y Zhao, 1 Emil y White, 1 V er a Banning, 1 Jami e Buell, 1 Kie l Iwanik, 1 Je f fre y S . Ross, 1 Debora h Morosini, 1 Ana s Y ounes, 5 Ala n M . Hanash, 8 Elisabet h Paietta, 9 Kathry n Roberts, 10 Charle s Mullighan, 10 Ahme t Dogan, 1 1 Scot t A . Armstrong, 4,6,7 T ari q Mughal, 1,12 Jo-Ann e V ergilio, 1 Elain e Labrecque, 1 Rache l Erlich, 1 Christin e V ietz, 1 Roma n Y elensk y , 1 Phili p J . Stephens, 1 V incen t A . Mille r , 1 Marce l R . M . va n de n Brink, 8,13 Geo f f A . Otto, 1 Doro n Lipson, 1 an d Ros s L . Levine 2,3,6 1 Founda t io n Medi c ine , Ca m bridge , MA; 2 L e ukemi a Service , Departmen t o f Medicine, 3 Huma n Oncolog y an d Pathogen e si s Prog r am, 4 Cance r Biolog y and Ge n etic s Pr o gram, 5 L ymphom a Service , Departmen t o f Medicine, 6 Leukemi a Cente r , 7 Departmen t o f Pediatri c s , and 8 Bon e Marro w T ran s plan t S e rvice, Depar t men t o f Medicine , Memoria l Sloa n Ketter i n g Can c e r Center , Ne w Y o rk , N Y ; 9 Departmen t o f Medicin e (Oncology) , Alber t Einstei n Colleg e o f Medicine, Y eshi v a University , Ne w Y o rk , N Y ; 10 Departmen t o f Pathology , St . Jud e Childr e n s Researc h Hospital , Memphis , TN; 1 1 Departmen t o f Pathology , Me m orial Sloa n Ketter i n g Cance r Center , Ne w Y ork , N Y ; 12 Divisio n o f Hematolo g y a n d Oncology , T uft s Universi t y Medic a l Cen t er , B o ston , M A ; and 13 Divisio n of Hematolo g i c Oncology , Departmen t o f Medicine , Memoria l Sloa n K e tterin g Cance r Center , Ne w Y ork , N Y Ke y Points Nove l clinica l l y avail a ble comp r ehen s iv e geno m ic Th e spectru m o f somati c alteration s i n hematol o gi c malignan c ie s include s substitut i ons, insertion s /deletion s (indels) , cop y numbe r alteration s (CNAs) , an d a wid e rang e o f gene fusions ; n o curren t clinicall y availabl e singl e assa y captu r e s th e di f feren t type s of alteration s . W e develope d a nove l next-gener a tio n sequencin g -base d assa y t o identif y all For personal use onl y . on March 26, 2018. by guest ww w .bloodjournal.org From Validation published in Blood 2016 7

Patient testimonials

Your patients, their perspectives

PLACEHOLDER FOR LOCALLY DEVELOPED CONTENT

*Comprehensive genomic profiling provides prognostic, diagnostic and predictive insights that inform treatment decisions for individual patients across all cancer types.

†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.

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

§For additional information on the NCCN categories please refer to the NCCN Compendium® (www.nccn.org).

¥Clinical validation demonstrated concordance with the following companion diagnostics: cobas® EGFR Mutation Test. Ventana ALK (DSF3) CDx Assay, Vysis ALK BreakApart FISH Probe Kit, therascreen® KRAS RGQ PCR Kit, Dako HER2 FISH PharmDx® Kit, cobas® BRAF V600 Mutation Test, THxlD® BRAF kit. For more information, please see the FoundationOne®CDx Technical Specifications available at: www.rochefoundationmedicine.com/f1cdxtech.

¶Clinical validation demonstrated concordance with the following diagnostics: cobas® EGFR Mutation Test v2, a tumor tissue polymerase chain reaction-based clinical trial assay (CTA), and an externally validated circulating cell-free DNA-based next-generation sequencing assay. For more information please see the FoundationOne Liquid®CDx Technical Specifications available at: www.eifu.online/FMl/190070862.

bTMB, blood Mutational Tumour Burden; FDA, US Food and Drug Administration; MSI, Microsatellite Instability; NCCN, Nat ional Comprehensive Cancer Network; NGS, next generation sequencing; TMB, Tumour Mutational Burden.

M-IE-00000628
References
  1. FoundationOne®CDx Technical Specifications, 2018. Available at: www.rochefoundationmedicine.com/f1cdxtech (Accessed August 2020).
  2. Data on file: FoundationOne Liquid CDx Technical Specifications, 2020. Available at: http://www.eifu.online/FMI/190070862 (Accessed August 2020).
  3. FoundationOne®Heme Technical Specifications, 2017. Available at: www.foundationmedicine.com/genomic-testing/foundation-one-heme (Accessed August 2020).
  4. Frampton GM et al. Nat Biotechnol 2013; 31: 1023–1031.
  5. Data on file: Clinical and analytical validation data file for FoundationOne Liquid CDx.
  6. Clark TA et al. J Mol Diagn 2018; 20: 686–702.
  7. He J et al. Blood 2016; 127: 3004–3014.
  8. Suh JH et al. Oncologist 2016; 21: 684–691.
  9. Chalmers ZR et al. Genome Med 2017; 9: 34.
  10. Rozenblum AB et al. J Thorac Oncol 2017; 12: 258–268.
  11. Schrock AB et al. Clin Cancer Res 2016; 22: 3281–3285.
  12. Ross JS et al. Gynecol Oncol 2013; 130: 554–559.
  13. Hall MJ et al. J Clin Oncol 2016; 34: 1523–1523
  14. FoundationOne®CDx Sample Report. Available at: https://www.foundationmedicine.nl/content/dam/rfm/sample-reports/f1cdx/eu_version_-_ema_without_page_1/F1CDx%20EU%20Sample%20Report%20(Lung).pdf (Accessed August 2020).
  15. A search for "Foundation Medicine"[Affiliation] on the NCBI database resulted in 518 publications, as of April 2020. Available at: https://www.ncbi.nlm.nih.gov/pubmed/?term=%22Foundation+Medicine%22%5BAffiliation%5D (Accessed August 2020)
  16. Foundation Medicine Publications. Available at: https://www.foundationmedicine.com/publications (Accessed August 2020).
  17. FoundationOne®CDx FDA Approval, 2017. Available at: 
    https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170019a.pdf (Accessed August 2020).
  18. FoundationOne®CDx Clinical Validation, 2017. Available at: http://www.foundationmedicine.com/genomic-testing/foundation-one-cdx (Accessed August 2020).
  19. FoundationOne Liquid CDx FDA Approval, 2020. Available at: www.foundationmedicine.com/press-releases/445c1f9e-6cbb-488b-84ad-5f133612b721 (Accessed August 2020).