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Our liquid biopsy comprehensive genomic profiling service for patients with solid tumours.1,2
  

FoundationOne® Liquid: A next-generation liquid biopsy test

FoundationOne® Liquid is an additional CGP service for patients with solid tumours.1,2 FoundationOne® Liquid provides an alternative biopsy service for patients that are not suitable candidates for CGP with FoundationOne® CDx.2 Liquid biopsy may provide an opportunity to perform non-invasive, blood-based genomic profiling when: 

  • Insufficient or inadequate tissue from a recent biopsy is obtained
  • The tumour is “difficult to reach”
  • Biopsy poses an unacceptable risk to the patient or is contraindicated
  • Progression or recurrence are suspected, repeat biopsy is infeasible or intratumour heterogeneity is suspected4

FoundationOne® Liquid allows for a blood-based genomic profiling approach to help support treatment decisions for patients with solid tumours

W he r e ti s sue biop s y is not possible or sample is insufficient for analysis 3 Granted breakthrough device designation by the FDA 8 Incorporates results from a prior analytically validated version of the FoundationOne® platform2† and utilises a knowledge base of over 200,000 genomic profiles 7 R eports MSI-High s t a tus 6 De t ects the f our main cla s ses of genomic al t e r a tions in 7 0 genes 6* T w o t u b e s o f 8 .5 mL p e riph e r a l who le blo o d 5 Clear,in-depth report Measures 70 genesand reports MSI-High status Singleblood draw ComplementsFoundationOne®CDx Supports your clinical decision-making by identifying clinically relevant alterations and may match these to targeted therapies, immunotherapies or clinical trials 1
Clinical uses

Identifies actionable results using peripheral blood from a single draw5‡

FoundationOne® Liquid extends the benefits of CGP to additional clinical situations with a single blood draw. 5‡ Liquid biopsies are a non-invasive tool for biomarker testing, which may replace the use of invasive solid tumour biopsies (associated with complications and increased morbidity). As liquid biopsies can be scheduled more frequently during treatment, measurements of tumour burden and early evidence of recurrence or resistance can be identified across several time points. Liquid biopsy may also better reflect the genetic profile of an individual tumour as it provides a full snapshot of information, unlike tissue biopsies which only reflect the specific area of the tumour biopsied.9

Clinicians should primarily use FoundationOne® CDx where tissue is available; when tissue biopsy is not feasible, there is insufficient tissue for analysis and/or when disease progression is suspected, FoundationOne® Liquid may offer a suitable alternative.2–4

Disease progressionsuspected Treatment draw If tissue insufficient for analysis Tissue biopsy not feasible Tissue biopsy feasible Solid tumour patient Single blood
Genes and biomarkers

Analyses 70 genes and reports MSI-High status

FoundationOne® Liquid leverages the CGP approach and detects the four main classes of genomic alterations in 70 genes plus MSI-High status from a single test.1,5,6* High specificity and sensitivity ensure you can be confident in the alterations reported.1,2
MSI Base substitutions Insertions and deletions Copy number alterations Microsatellite instability Rearrangements Analyses70known cancer-relevant genes

ctDNA

Examines circulating tumour DNA (ctDNA)

When people have cancer, their blood contains circulating cell-free DNA released from both healthy tissue and tumour tissue (ctDNA).3 ctDNA is highly fragmented, occurs in very low amounts and varies between tumour type and individual patients.10,11 FoundationOne® Liquid utilises ctDNA extraction to accurately identify unique ctDNA fragments from a single blood draw.‡1,2,5
Tumour TissueApoptosisNecrosisSecretion Healthy TissueMain source of cell-free DNA Releasecell-free DNA Apoptosis Release ctDNA
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, which may have been approved by the FDA.1
Biomarker findingsIdentifies MSI-High if present Mutant allele frequency percentage (MAF%)For base substitutions, insertions and deletions (indels) Therapies and clinical trialsClinically relevant targeted therapiesand clinical trials for identifiedalterations to help guide treatmentstrategies Genomic findingsClinically relevant alterations in 70tested cancer-related genes Gene alterations with noreportable optionsTo help rule out uncertainty anddetermine the most appropriate courseof action Tumour evolutionIncorporates results from priorFoundation Medicine services.The possibility to include results fromprior Foundation Medicine servicesvaries by region. We are working onmaking this feature broadly available.Please contact your localrepresentative for more information Lung A denoca r cinoma TU M OR TYP E Sample, Jane P A T I EN T RE P O R T D A T E 0 1 Jan 2 0 18 X X X X X X X X CRF # F o u n d a t i o n A CT® is a n e xt g e n e r a t io n s e q ue n ci n g ( N GS) a s s a y t h a t i d e n t i es c lin i cal l y r e l e v a n t g e n o m i c al t e r a t io n s in ci r c u l a t i n g t u m o r D N A. ABOUT THE TE S T P A TIENT SEX Not Gi v en MEDICAL R E C ORD # Not Gi v en D A TE OF BI R TH Not Gi v en DISEASE Lung A denoca 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 DATE OF COLLECTION Not Given SPECIMEN RECEIVED Not Given SPECIMEN ID Not Given SPECIMEN TYPE Blood 0 . 20% e x on 19 deletion (L 7 4 7_A 7 50> P ) E GFR Afatinib Erlotinib Gefitinib Osimertinib Cetuximab Lapatinib Panitumumab see p . 8 10 Trials EGFR exon 19 deletion (L747_A750>P) TP53 C242G 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 . G e n o m i c F i n di n g s B io ma r k e r F i n di n g s No reportable biomarker findings were detected. C linical T rials 10 T he r apies with Lack of R esponse 0 T he r apies with C linical Benefit 7 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 io 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 E A L TER A TION S W ITH N O RE P O R T A BLE THER AP EUTIC OR CLI N I C A L TR IA L S O P TION S p . 3 C 2 4 2 G 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 F D A - app r o v ed drugs; 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. 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. In the app r opri a t e clinical c on t e x t, g ermline t e s ting o f A P C , B R C A1, B R C A2, CDH1, NF1, P ALB2, RB1, RE T , S TK11, and TP 5 3 is r e c ommended. N / A= N o t Applicable; Mutant Allele F r equen c y is n o t applicable f or c o p y number amplific a tions or r e ar r an g emen t s. N O TE 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 A CTIO NA BIL I T Y BIOM AR KER FI N DI N G S There are no Biomarker Findings for this sample THERAPIES WITH CLINICAL BENEFIT (IN OTHER TUMOR TYPE) THERAPIES WITH CLINICAL BENEFIT (IN PATIENT’S TUMOR TYPE) GE N OMIC FI N DI N G S MAF % F oundationOneLiquid ® is a n e xt g ene r ation sequencing (NGS) a s s a y that identifies clinically r el ev ant g enomic al t e r ations in ci r culating tumor DNA. Lung A denoca r cinoma TU M OR TYP E Sample, Jane P A T I EN T RE P O R T D A T E 0 1 Jan 2 0 18 X X X X X X X X CRF # F o u n d a t i o n A CT® is a n e xt g e n e r a t io n s e q ue n ci n g ( N GS) a s s a y t h a t i d e n t i es c lin i cal l y r e l e v a n t g e n o m i c al t e r a t io n s in ci r c u l a t i n g t u m o r D N A. ABOUT THE TE S T P A TIENT SEX Not Gi v en MEDICAL R E C ORD # Not Gi v en D A TE OF BI R TH Not Gi v en DISEASE Lung A denoca 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 DATE OF COLLECTION Not Given SPECIMEN RECEIVED Not Given SPECIMEN ID Not Given SPECIMEN TYPE Blood 0 . 20% e x on 19 deletion (L 7 4 7_A 7 50> P ) E GFR Lorem ipsum DRUG NAME DRUG NAME DRUG NAME DRUG NAME DRUG NAME DRUG NAME DRUG NAME see p . 8 10 Trials EGFR exon 19 deletion (L747_A750>P) TP53 C242G 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 . G e n o m i c F i n di n g s B io ma r k e r F i n di n g s No reportable biomarker findings were detected. C linical T rials 10 T he r apies with Lack of R esponse 0 T he r apies with C linical Benefit 7 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 io 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 E A L TER A TION S W ITH N O RE P O R T A BLE THER AP EUTIC OR CLI N I C A L TR IA L S O P TION S p . 3 C 2 4 2 G 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 F D A - app r o v ed drugs; 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. 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. In the app r opri a t e clinical c on t e x t, g ermline t e s ting o f A P C , B R C A1, B R C A2, CDH1, NF1, P ALB2, RB1, RE T , S TK11, and TP 5 3 is r e c ommended. N / A= N o t Applicable; Mutant Allele F r equen c y is n o t applicable f or c o p y number amplific a tions or r e ar r an g emen t s. N O TE 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 A CTIO NA BIL I T Y BIOM AR KER FI N DI N G S There are no Biomarker Findings for this sample THERAPIES WITH CLINICAL BENEFIT (IN OTHER TUMOR TYPE) THERAPIES WITH CLINICAL BENEFIT (IN PATIENT’S TUMOR TYPE) GE N OMIC FI N DI N G S MAF % F oundationOneLiquid ® is a n e xt g ene r ation sequencing (NGS) a s s a y that identifies clinically r el ev ant g enomic al t e r ations in ci r culating tumor DNA. Solid tumor bio p s y 2 5 F eb 2 0 17 Liquid bio p s y 7 Apr 2 0 17 Liquid bio p s y 12 Jun 2 0 17 N o t De t ec t ed Mu t ant Allele F r eq u ency P e r c en t a g e (MAF%) Mic r o s a t elli t e s t a tus de t ec t ed Cann o t Be De t ermined 2 3 . 00% n / a e x on 19 deletion (L 7 4 7_A 7 50> P ) E GFR Cann o t Be De t ermined T umor Mut a tional Bu r den T E S T 1 T E S T 2 MA F % 0 . 20% n / a T E S T 3 MA F % - 2 2.8% N o t T es t ed N o t T es t ed C H AN G E F R O M PR E V . HI S T O R IC P A TIE N T FI N DI N G S 2% 40% 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 de t ec t ed 12 . 50% C 2 42G TP53 0 . 10% - 12 . 40% Lung A denoca r cinoma TU M OR TYP E Sample, Jane P A T I EN T RE P O R T D A T E 0 1 Jan 2 0 18 X X X X X X X X CRF # Solid tumor bio p s y 2 5 F eb 2 0 17 Liquid bio p s y 7 Apr 2 0 17 Liquid bio p s y 12 Jun 2 0 17 N o t De t ec t ed Mu t ant Allele F r eq u ency P e r c en t a g e (MAF%) Mic r o s a t elli t e s t a tus de t ec t ed Cann o t Be De t ermined 2 3 . 00% n / a e x on 19 deletion (L 7 4 7_A 7 50> P ) E GFR Cann o t Be De t ermined T umor Mut a tional Bu r den T E S T 1 T E S T 2 MA F % 0 . 20% n / a T E S T 3 MA F % - 2 2.8% N o t T es t ed N o t T es t ed C H AN G E F R O M PR E V . HI S T O R IC P A TIE N T FI N DI N G S 2% 40% 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 de t ec t ed 12 . 50% C 2 42G TP53 0 . 10% - 12 . 40% Lung A denoca r cinoma TU M OR TYP E Sample, Jane P A T I EN T RE P O R T D A T E 0 1 Jan 2 0 18 X X X X X X X X CRF # 2 5 6 1 3 4 2 5 6 1 3 4

Order

Order FoundationOne Liquid

Ordering a FoundationOne® Liquid test is simple and convenient

For more information about the ordering process, contact the Roche Foundation Medicine Customer Care Team:

Freephone: 0800 731 5711

Email: uk.foundation@roche.com

For technical and scientific enquiries related to the Foundation Medicine service, please contact the Medical Information team on:

Freephone: 0800 328 1629

Email: medinfo.uk@roche.com

 

Experience how FoundationOne® Liquid could guide treatment decision-making with samples from a single blood draw.

*Base substitutions, insertions or deletions, copy number alterations and gene rearrangements.

FoundationACT is a prior version of FoundationOne® Liquid which analysed 62 genes and has been analytically validated.2

Two tubes of whole peripheral blood are required (8.5 ml per tube) per patient.5

CGP: comprehensive genomic profiling; ctDNA: circulating tumour DNA; MSI: microsatellite instability.

RXUKRFMI00099 November 2019

References
  1. FoundationOne® Liquid Technical Specifications. Last accessed November 2019.
  2. Clark TA et al. J Mol Diagn. 2018;20:686–702.
  3. Jung A, et al. Dtsch Arztebl Int. 2018;115:169–174.
  4. Gerlinger M, et al. N Engl J Med. 2012;366:883–892.
  5. FoundationOne® Liquid Specimen Instructions. Last accessed November 2019.
  6. FoundationOne® Liquid Gene List. Last accessed November 2019.
  7. FoundationInsights™. Available at: https://www.foundationmedicine.com/insights-and-trials/foundation-insights. Last accessed November 2019.
  8. Foundation Medicine Media Release. Foundation Medicine’s New Liquid Biopsy Assay Granted Breakthrough Device Designation by U.S. Food and Drug Administration. 26 April 2018.
  9. Di Meo A, et al. Mol Cancer. 2017;16:80.
  10. Elazezy M, Joosse SA. Comput Struct Biotechnol J. 2018;16:370–378.
  11. Merker JD, et al. J Clin Oncol. 2018;36:1631–1641.