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Comprehensive genomic profiling service for haematological malignancies and sarcomas; to guide diagnosis, prognosis and treatment selection and personalise patients' treatment plans.1- 3

Use multiple sample typesClear in-depth reportDNA+RNAReports TMB and MSI to help explore the role of immunotherapies1Sequences RNA of 265 genes to capture a broad range of gene fusions1Personalised treatment TMB and MSITMBMSI

Comprehensive assessment in a single test

FoundationOne Heme comprehensively analyses the cancer genome to identify clinically relevant genomic alterations in haematological malignancies and sarcomas.1-2
Base substitutionsRearrangementsTumour mutationalburdenMicrosatellite instabilityTMBMSISequences RNA of 265 genes to capture a broad range of gene fusions1Reports TMB and MSI,which can help inform the use of immunotherapies1

Delivers insights in a single test, thus saving time and avoiding repeat biopsy versus sequential biomarker testing1

Integrated DNA and RNA sequencing helps identify common, rare, and novel gene fusions and rearrangements1,2

Distribution of rearrangements called by detection method2

DNARNADNA+RNADNA sequencing allows high sensitivity for well-characterised rearrangements rearrangements that do not result in expression of a fusion transcriptRNA sequencing captures a broad range of gene fusionsIntegrated DNA and RNA sequencing for detection of complex genomic rearrangementsData shown for 20% tumour purity. Sequencing was carried out on 21 pooled cell lines with 28 known genomic rearrangementsData generated from cell line mixes with known rearrangements/fusions.DNARNADNA+RNANumber of rearrangements05101520253035404550

FoundationOne Heme gene list FoundationOne Heme gene list
Learn more about comprehensive genomic profiling Learn more about comprehensive genomic profiling

Supports clinical decision-making

A clear, in-depth report supports your clinical decision-making by providing insights on the genomic profile of your patient as well as associated targeted therapies, immunotherapies and relevant clinical trials. The report also highlights important diseaserelevant genes with no reportable alterations identified and genomic alterations associated with potential resistance to therapy, to help rule out ineffective treatment.23

Reports four main classes of alterations spanning the DNA of 406 genes and the RNA of 265 genes in just 3 weeks following receipt of the sample at our laboratory1

FoundationOne Heme sample report FoundationOne Heme sample report

Personalises treatment plans in haematological malignancies

FoundationOne Heme enables guideline-recommended testing to help guide diagnosis, prognosis and treatment selection, with the potential to improve patient outcomes.1,4- 17
Haematological malignanciesImproves diagnosis • Confirms malignancy and disease subtype1,12,13Informs prognosis• Supports risk stratification and treatment planning1,4,11,14–17,24Supports treatment selection• Identifies targeted therapies, immunotherapies and relevant clinical trials associated with your patient’s genomic profile23

Using FoundationOne Heme for haematological malignancies

AMLTo identify genomic alterations for prognostication, therapy selection and clinical trial enrolment e.g. KIT, FLT3-ITD, NPM1, and CEBPA1,2,5 MMTo identify t(4;14), t(14;16) and del(17)p to support risk stratification as well as other genomic alterations that may guide therapy selection and clinical trial enrolment (e.g. KRAS, NRAS, BRAF and others)1,2,7,26MDS/MPNTo identify genomic alterations for prognostication, therapy selection and clinical trial enrolment e.g. JAK2, CALR, MPL and others1,2,6,10DLBCLTo identify genomic alterations to inform diagnosis and prognosis (MYC, BCL2, and BCL6) and those with known therapeutic associations (e.g. EZH2, TET2, CD79, PTEN and others)1,8,14,27ALLTo identify BCR-ABL1 and Ph-like fusions, point mutations which may confer sensitivity to TKIs, and other clinically relevant genomic alterations (e.g. JAK2, CRLF2 and others)1,2,4,25CLLTo identify genomic alterations which can inform prognosis (IGH gene rearrangements and TP53) and guide therapy selection (TP53, BTK and PLCG2)1,11,28,31

Personalises treatment plans for sarcomas

FoundationOne Heme helps guide diagnosis, prognosis and treatment select ion, with the potential to improve outcomes for sarcoma patients.1,3,18-20
SarcomaImproves diagnosis • More than 50 histological subtypes and new genomic findings which continue to refine sarcoma classification (e.g. CTNNB1 in desmoid tumours)18,19,20• Accurate diagnosis is a crucial first step in determining your patient’s treatment plan1,3,18–20Informs prognosis• Identifies gene fusions with prognostic value (e.g. PDGFRA in GIST, PAX7-FOXO1 and PAX3-FOXO1 in alveolar RMS)1,18Supports treatment selection• Detects NTRK gene fusions, an alteration found in certain sarcoma subtypes that is the target of emerging therapies1,32,33• Identifies GIST patients with KIT or PDGFRA alterations, which may predict response to targeted therapy1,3,19,34• Identifies relevant clinical trials, an integral part of sarcoma management given the limited number of therapeutic options1,3,19,21

High clinical utility in paediatric patients

  1. FoundationOne Heme is for haematological malignancies and sarcomas, which have relatively high incidences among malignancies in the paediatric population18,35
  2. FoundationOne Heme integrates DNA and RNA sequencing to identify complex genomic rearrangements, which are characteristic of haematological malignancies and sarcomas in paediatric patients1,13,35-38
Age groupFusion prevalence in AML patients by age1Fusion prevalence (%)1003020100<54050607080905–1516–2526–4041–5556–6566–75>75

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Order FoundationOne Heme

Experience how FoundationOne Heme can guide diagnosis, prognosis and treatment selection, and help personalise your patients' treatment plans.1- 3

FoundationOne Heme samples can be shipped to our Penzberg (Germany) or Cambridge (US) laboratories for patients in the EU or the rest of the world, respectively, enabling more patients to benefit from comprehensive genomic profiling with FoundationOne Heme.†

Acceptable specimen types:

1. For haematological malignancies, multiple specimen types are acceptable; FoundationOne Heme has been validated with blood, bone marrow aspirate and FFPE tissue samples1,39

2. For sarcoma, please use FFPE tissue samples39

3. Our dedicated c lient service team offers information and support to ensure specimen requirements for analysis are met

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View FoundationOne Heme Technical Specifications View FoundationOne Heme Technical Specifications
View FoundationOne Heme Specimen Instructions View FoundationOne Heme Specimen Instructions
Any questions? Any questions?

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

†Peripheral blood and bone marrow aspirate must be received the day after collection for optimal analysis as sensitivity of detection may degrade with t ime. Samples arriving later will result in a Qualified Report. FFPE block or slides are also accepted.

AML, acute myeloid leukaemia. ALL, acute lymphoblastic leukaemia. CLL, chronic lymphocytic leukaemia. GIST, gastrointestinal stromal tumours. DLBCL, diffuse large 8-cell lymphoma. FFPE, formalin-fixed paraffin-embedded. MOS, myetodysplastic syndrome. MM, multiple myeloma. MPN, myeloproliferative neoplasms. MSI, microsatellite instability. RMS, rhabdomyosarcoma. TKI, tyrosine kinase inhibitor. TMB, tumour mutational burden.

References
  1. FoundationOne®Heme Technical Specifications, 2019. Available at: www.foundationmedicine.com/genomic-testing/foundation-one-heme (Accessed August 2020).
  2. He J et al. Blood 2016; 127: 3004–3014.
  3. Gounder M et al. Presented at ASCO Annual Meeting 2017, Chicago (Illinois), USA: Abstract #11001 and oral presentation.
  4. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Acute Lymphoblastic Leukaemia. V.1.2018, 2018. Available at: https://www.nccn.org/professionals/physician_gls/default.aspx (Accessed August 2020).
  5. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Acute Myeloid Leukaemia. V.1.2019, 2019. Available at: https://www.nccn.org/professionals/physician_gls/default.aspx (Accessed August 2020).
  6. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Myelodysplastic Syndromes. V.2.2019, 2018. Available at: https://www.nccn.org/professionals/physician_gls/default.aspx (Accessed August 2020).
  7. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Multiple Myeloma. V.2.2019, 2018. Available at: https://www.nccn.org/professionals/physician_gls/default.aspx (Accessed August 2020).
  8. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). B-cell Lymphoma. V.1.2019, 2018. Available at: https://www.nccn.org/professionals/physician_gls/default.aspx (Accessed August 2020).
  9. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). T-cell Lymphoma. V.2.2019, 2018. Available at: https://www.nccn.org/professionals/physician_gls/default.aspx (Accessed August 2020).
  10. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Myeloproliferative Neoplasms. V.2.2019, 2018. Available at: https://www.nccn.org/professionals/physician_gls/default.aspx (Accessed August 2020).
  11. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Chronic Lymphocytic Leukaemia. V.5.2019, 2018. Available at: https://www.nccn.org/professionals/physician_gls/default.aspx (Accessed August 2020).
  12. Morley S et al. Blood 2015; 126: 3898.
  13. Kobos R et al. Presented at ASH Annual Meeting 2016, San Diego (California), USA: Abstract 1605.
  14. He J et al. Presented at ASH Annual Meeting 2015, Orlando (Florida), USA: Abstract 2651.
  15. Galanina N et al. Cancers (Basel) 2018; 11.pii: E11.
  16. Goodman AM et al. Mol Cancer Ther 2017; 16: 2598–2608.
  17. Heuck C et al. Blood 2015; 126: 369.
  18. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Soft Tissue Sarcoma. V.2.2019, 2019. Available at: https://www.nccn.org/professionals/physician_gls/recently_updated.aspx (Accessed August 2020).
  19. Groisberg R et al. Oncotarget 2017; 8: 39254–39267.
  20. Doyle LA et al. Cancer 2014; 120: 1763–1774.
  21. Cote GM et al. Oncologist 2018; 23: 234–242.
  22. Chmielecki J et al. Cancer Res 2017; 77: 509–519.
  23. Data on file: FoundationOne®Heme Sample Report. 2018.
  24. Chavan SS et al. Blood Cancer J 2017; 7: e535.
  25. Severson EA et al. Presented at ASH Annual Meeting 2017, Atlanta (Georgia), USA: Abstract 476.
  26. Bustoros M et al. Am Soc Clin Oncol Educ Book 2017; 37: 548–560.
  27. Bolen J et al. Blood 2017; 130: 2729.
  28. Grzegorz S et al. Blood 2007; 110: 2067.
  29. Rossi D et al. Clin Cancer Res 2009; 15: 995–1004.
  30. Zenz T et al. J Clin Oncol 2010; 28: 4473–4479.
  31. Woyach JA et al. J Clin Oncol 2017; 35: 1437–1443.
  32. VITRAKVI® (larotrectinib) Prescribing Information. Available at: https://www.loxooncology.com/docs/general/vitrakvi.pdf (Accessed August 2020).
  33. Vaishnavi A et al. Cancer Discov 2015; 5: 25–34.
  34. GLEEVEC® (imatinib mesylate) Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021588s024lbl.pdf (Accessed August 2020).
  35. Tarlock K et al. Oncotarget 2018; 9: 26417–26430.
  36. Severson EA et al. Presented at ASH Annual Meeting 2017, Atlanta (Georgia), USA: Abstract 476.
  37. Chmielecki J et al. Cancer Res 2017; 77: 509–519.
  38. Pavlick D et al. Pediatr Blood Cancer 2017; 64: e26433.
  39. FoundationOne®Heme Specimen Instructions, 2018. Available at: https://assets.ctfassets.net/vhribv12lmne/36S2Vq3BPqwaTLoww8gerj/78a3f27012a3b3ea9e3064561dc22a02/F1H_Specimen_Instructions.pdf (Accessed August 2020).