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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

FoundationOne® Heme

What is FoundationOne® Heme?

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

FoundationOne® Heme for haematological malignancies is NOT AVAILABLE in Malaysia

 

 

Genes and biomarkers

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

 

 

In-depth report

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 disease relevant 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

 

 

Sarcoma

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 patients 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 therapies1,24,25 Identifies GIST patients with KIT or PDGFRA alterations, which may predict response to targeted therapy1,3,19,26 Identifies relevant clinical trials, an integral part of sarcoma management given the limited number of therapeutic options1,3,19,21

 

 

Order

Order FoundationOne® Heme

In Malaysia, accepted specimen types is FFPE block or slides. FoundationOne® Heme is available in Malaysia for Sarcomas with specimen type in the form of FFPE block or slides. As blood and bone marrow aspirates for haematological malignancies must be received the day after collection for optimal analysis27, Malaysia may not be able to offer the FoundationOne® Heme testing for haematological malignancies at this moment. We are working to make FoundationOne® Heme more broadly available.

"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 time. Samples arriving later will result in a Qualified Report. FFPE block or slides are also accepted.

GIST, gastrointestinal stromal tumours. FFPE, formalin-fixed paraffin-embedded. MSI, microsatellite instability. RMS, rhabdomyosarcoma. TMB, tumour mutational burden.

References
  1. FoundationOne®Heme Technical Specifications, 2022. Available at: www.foundationmedicine.qarad.eifu.online/foundationmedicine/en/foundationmedicine (Accessed September 2023).
  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. Acute Lymphoblastic Leukaemia. Version 2.2023, July 2023. Available at: www.nccn.org/professionals/physician_gls/pdf/all.pdf (Accessed September 2023).
  5. NCCN Clinical Practice Guidelines in Oncology. Acute Myeloid Leukaemia. Version 4.2023, July 2023. Available at: www.nccn.org/professionals/physician_gls/pdf/aml.pdf (Accessed September 2023).
  6. NCCN Clinical Practice Guidelines in Oncology. Myelodysplastic syndromes. Version 1.2023, September 2022. Available at: www.nccn.org/professionals/physician_gls/pdf/mds.pdf (Accessed September 2023).
  7. NCCN Clinical Practice Guidelines in Oncology. Multiple Myeloma. Version 4.2023, August 2023. Available at: www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf (Accessed September 2023).
  8. NCCN Clinical Practice Guidelines in Oncology. B-cell Lymphomas. Version 5.2023, July 2023. Available at: www.nccn.org/professionals/physician_gls/pdf/b-cell.pdf (Accessed September 2023).
  9. NCCN Clinical Practice Guidelines in Oncology. T-cell Lymphomas. Version 1.2023, January 2023. Available at: www.nccn.org/professionals/physician_gls/pdf/t-cell.pdf (Accessed September 2023).
  10. NCCN Clinical Practice Guidelines in Oncology. Myeloproliferative neoplasms. Version 2.2023, August 2023. Available at: www.nccn.org/professionals/physician_gls/pdf/mpn.pdf (Accessed September 2023).
  11. NCCN Clinical Practice Guidelines in Oncology. Chronic Lymphocytic Leukaemia. Version 3.2023, June 2023. Available at: www.nccn.org/professionals/physician_gls/pdf/cll.pdf (Accessed September 2023).
  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. JCO Precis Oncol 2017. doi: 10.1200/PO.16.00004. 
  17. Heuck C et al. Blood 2015; 126: 369.
  18. NCCN Clinical Practice Guidelines in Oncology. Soft Tissue Sarcoma. Version 2.2023, April 2023. Available at: www.nccn.org/professionals/physician_gls/pdf/sarcoma.pdf (Accessed September 2023).
  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. FoundationOne®Heme Sample Report, 2019. Available at: www.foundationmedicine.my/content/dam/rfm/my_v2/Documents/F1H_Soft_Tissue_Sarcoma_(NOS)_sample_report_v2.pdf (Accessed July 2021).
  24. VITRAKVI® (larotrectinib) Prescribing Information. Available at: https://www.ema.europa.eu/en/documents/product-information/vitrakvi-epar-product-information_en.pdf (Accessed September 2023).
  25. Vaishnavi A et al. Cancer Discov 2015; 5: 25–34.
  26. GLEEVEC® (imatinib mesylate) Prescribing Information. Available at: www.accessdata.fda.gov/drugsatfda_docs/label/2008/021588s024lbl.pdf (Accessed July 2021).
  27. FoundationOne®Heme Specimen instructions, 2022. Available at: www.foundationmedicine.qarad.eifu.online/foundationmedicine/en/foundationmedicine (Accessed September 2023).