A leading comprehensive genomic profiling approach

Our 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.1–12 Comprehensive genomic profiling detects 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) and microsatellite instability (MSI).*1–6

What makes comprehensive genomic profiling different?

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

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. 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.13

FoundationOnCDx is a next-generation sequencing (NGS) based assay that identies genomic findings within hundreds of cancer-related genes. ABOUT THE TEST XXXXXXXX QRF# 01 Jan 2018 REPORT DATE Lung adenocarcinoma TUMOR TYPE Sample, Jane PATIENT PATIENT SEX Female MEDICAL RECORD # Not Given DATE OF BIRTH Not Given DISEASE Lung adenocarcinoma NAME Not Given PHYSICIAN ORDERING PHYSICIAN Not Given PATHOLOGIST Not Given MEDICAL FACILITY ID Not Given MEDICAL FACILITY Not Given ADDITIONAL RECIPIENT Not Given SPECIMEN SPECIMEN SITE Not Given DATE OF COLLECTION Not Given SPECIMEN RECEIVED Not Given SPECIMEN ID Not Given SPECIMEN TYPE Not Given Electronically Signed by Julia A. Elvin, M.D., Ph.D. • Jeffrey S. Ross, M.D., Medical Director • 30 November 2017 Foundation Medicine, Inc. • 1-888-988-3639 Sample Preparation: 150 Second St., 1st Floor, Cambridge, MA 02141 • CLIA: 22D2027531 Sample Analysis: 150 Second St., 1st Floor, Cambridge, MA 02141 • CLIA: 22D2027531 of PAGE Genomic Findings Biomarker Findings 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 For a complete list of the genes assayed, please refer to the Appendix. see p. 17 5 Trials THERAPIES WITH CLINICAL BENEFIT (IN OTHER TUMOR TYPE) THERAPIES WITH CLINICAL BENEFIT (IN PATIENT’S TUMOR TYPE) GENOMIC FINDINGS amplification, L858R EGFR T416S PTCH1 Erlotinib Afatinib Atezolizumab Avelumab Nivolumab Durvalumab Pembrolizumab None Gefitinib Osimertinib Cetuximab Sonidegib Lapatinib Vismodegib Panitumumab see p. 16 4 Trials see p. 14 9 Trials TMB-Intermediate (11 Muts/Mb) Tumor Mutational Burden THERAPIES WITH CLINICAL BENEFIT (IN OTHER TUMOR TYPE) THERAPIES WITH CLINICAL BENEFIT (IN PATIENT’S TUMOR TYPE) BIOMARKER FINDINGS No therapies or clinical trials. MS-Stable Microsatellite status see Biomarker Findings section Clinical Trials 18 Therapies with Lack of Response 0 Therapies with Clinical Benefit 14 FoundationOnCDx is a next-generation sequencing (NGS) based assay that identies genomic findings within hundreds of cancer-related genes. ABOUT THE TEST XXXXXXXX QRF# 01 Jan 2018 REPORT DATE Lung adenocarcinoma TUMOR TYPE Sample, Jane PATIENT PATIENT SEX Female MEDICAL RECORD # Not Given DATE OF BIRTH Not Given DISEASE Lung adenocarcinoma NAME Not Given PHYSICIAN ORDERING PHYSICIAN Not Given PATHOLOGIST Not Given MEDICAL FACILITY ID Not Given MEDICAL FACILITY Not Given ADDITIONAL RECIPIENT Not Given SPECIMEN SPECIMEN SITE Not Given DATE OF COLLECTION Not Given SPECIMEN RECEIVED Not Given SPECIMEN ID Not Given SPECIMEN TYPE Not Given Electronically Signed by Julia A. Elvin, M.D., Ph.D. • Jeffrey S. Ross, M.D., Medical Director • 30 November 2017 Foundation Medicine, Inc. • 1-888-988-3639 Sample Preparation: 150 Second St., 1st Floor, Cambridge, MA 02141 • CLIA: 22D2027531 Sample Analysis: 150 Second St., 1st Floor, Cambridge, MA 02141 • CLIA: 22D2027531 of PAGE Genomic Findings Biomarker Findings 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 For a complete list of the genes assayed, please refer to the Appendix. see p. 17 5 Trials THERAPIES WITH CLINICAL BENEFIT (IN OTHER TUMOR TYPE) THERAPIES WITH CLINICAL BENEFIT (IN PATIENT’S TUMOR TYPE) GENOMIC FINDINGS amplification, L858R EGFR T416S PTCH1 Erlotinib Afatinib Atezolizumab Avelumab Nivolumab Durvalumab Pembrolizumab None Gefitinib Osimertinib Cetuximab Sonidegib Lapatinib Vismodegib Panitumumab see p. 16 4 Trials see p. 14 9 Trials TMB-Intermediate (11 Muts/Mb) Tumor Mutational Burden THERAPIES WITH CLINICAL BENEFIT (IN OTHER TUMOR TYPE) THERAPIES WITH CLINICAL BENEFIT (IN PATIENT’S TUMOR TYPE) BIOMARKER FINDINGS No therapies or clinical trials. MS-Stable Microsatellite status see Biomarker Findings section Clinical Trials 18 Therapies with Lack of Response 0 Therapies with Clinical Benefit 14 Electronically Signed by Julia A. Elvin, M.D., Ph.D. • Jeffrey S. Ross, M.D., Medical Director • 30 November 2017 Foundation Medicine, Inc. • 1-888-988-3639 Sample Preparation: 150 Second St., 1st Floor, Cambridge, MA 02141 • CLIA: 22D2027531 Sample Analysis: 150 Second St., 1st Floor, Cambridge, MA 02141 • CLIA: 22D2027531 of PAGE For more information regarding biological and clinical signicance, including prognostic, diagnostic, germline, and potential chemosensitivi implications, see the Genomic Findings section. GENOMIC FINDINGS WITH NO REPORTABLE THERAPEUTIC OR CLINICAL TRIALS OPTIONS p. 5 loss CDKN2A/B p. 5 Q494* RBM10 p. 6 R267P TP53 Genomic alterations detected may be associated with activity of certain approved therapies; however, the agents listed in this report may have varied clinical evidence in the patients tumor type. Therapies and the clinical trials listed in this report may not be complete and exhaustive. Neither the therapeutic agents nor the trials identified are ranked in order of potential or predicted efficacy for this patient, nor are they ranked in order of level of evidence for this patients tumor type. This report should be regarded and used as a supplementary source of information and not as the single basis for the making of a therapy decision. All treatment decisions remain the full and final responsibility of the treating physician and physicians should refer to approved prescribing information for all therapies. NOTE Therapies contained in this report may have been approved by the US FDA. XXXXXXXX QRF# 01 Jan 2018 REPORT DATE Lung adenocarcinoma TUMOR TYPE Sample, Jane PATIENT 3 Therapies with clinical benefit Approved targeted therapies and immunotherapies for the patients genomic alterations and biomarkers Clinical trials Relevant trials that your patient may be eligible for, based on their genomic profile and geographical location 3 4 2 1 4 2 1 Biomarker findings TMB and MSI status*, which may help to inform immunotherapy treatment decisions Genomic findings Clinically relevant alterations in analysed cancer-related genes

View a sample report:

Validation

Validated and supported by clinical evidence

Our services are supported by a large and growing body of clinical evidence with over 200 publications since the founding of Foundation Medicine.14,15 The validation of Foundation Medicine’s comprehensive genomic profiling services is published in top-tier peer-reviewed journals.4–6

View validation:

FoundationOne
(predecessor to FoundationOne CDx)
Validation published in Nature Biotechnology 20134

FoundationOne CDx
Based on our analytically and clinically validated, FDA-approved comprehensive platform† 16,17

FoundationOne Liquid
Validation published in Journal of Molecular Diagnostics 20185

FoundationOne Heme
Validation published in Blood 20166

 

*TMB reported in FoundationOne CDx and FoundationOne Heme. MSI reported in FoundationOne CDx, FoundationOne Liquid and FoundationOne Heme.

†Clinical 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 available at: www.rochefoundationmedicine.com/f1cdxtech.

FDA, US Food and Drug Administration. MSI, microsatellite instability. NGS, next generation sequencing. TMB, tumour mutational burden.

FOUNDATIONONE®HEME not yet available in the Netherlands

References
  1. FoundationOne®CDx Technical Specifications, 2018. Available at: www.rochefoundationmedicine.com/f1cdxtech (Accessed March 2019).
  2. FoundationOne®Liquid Technical Specifications, 2018. Available at: https://www.foundationmedicine.com/genomic-testing/foundation-one-liquid (Accessed March 2019).
  3. FoundationOne®Heme Technical Specifications, 2017. Available at: www.foundationmedicine.com/genomic-testing/foundation-one-heme (Accessed March 2019).
  4. Frampton GM et al. Nat Biotechnol 2013; 31: 1023–1031.
  5. Clark TA et al. J Mol Diagn 2018; 20: 686–702.
  6. He J et al. Blood 2016; 127: 3004–3014.
  7. Suh JH et al. Oncologist 2016; 21: 684–691.
  8. Chalmers ZR et al. Genome Med 2017; 9: 34.
  9. Rozenblum AB et al. J Thorac Oncol 2017; 12: 258–268.
  10. Schrock AB et al. Clin Cancer Res 2016; 22: 3281–3285.
  11. Ross JS et al. Gynecol Oncol 2013; 130: 554–559.
  12. Hall MJ et al. J Clin Oncol 2016; 34: 1523–1523.
  13. FoundationOne®CDx Sample Report, 2018. Available at: www.rochefoundationmedicine.com/reporting (Accessed March 2019).
  14. A search for “Foundation Medicine”[Affiliation] on the NCBI database resulted in 321 publications, as of October 2018. Available at: https://www.ncbi.nlm.nih.gov/pubmed/term=%E2%80%9CFoundation+Medicine%E2%80%9D%5BAffiliation%5D (Accessed March 2019).
  15. Foundation Medicine Publications. Available at: https://www.foundationmedicine.com/publications (Accessed March 2019).
  16. FoundationOne®CDx FDA Approval, 2017. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170019a.pdf (Accessed March 2019).
  17. FoundationOne®CDx clinical validation, 2017. Available at: http://www.foundationmedicine.com/genomic-testing/foundation-one-cdx (Accessed March 2019).