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Our FDA-approved liquid biopsy comprehensive genomic profiling service offers a minimally-invasive option,
alternative or complementary to FoundationOne CDx, for all patients with solid tumours at optimal times beneficial to their treatment journey1-3

Based on our analytically and clinically validated, FDA-approved comprehensive genomic profiling platform and bioinformatics workflow§13,17,18Less than 2 weeks turnaround time from receipt of the sample at our laboratory to report1Suited for all solid tumours based on your patients profile and the available clinical evidence1,2,14,15Option of reflex testing to FoundationOne CDx if no actionable genomicalterations are detected in the liquid biopsy sample1,15,18Quick and convenient single blood draw (2 x 8.5 mL whole blood) helps avoid invasive biopsies and enables faster treatment decisions1,1216Assesses all four main classes of genomic alterations* in >300† cancer-related genes plusMSI, bTMB and Tumour Fraction1,2,411Reflex testingAll solidtumoursFDA-approvedQuick turnaround timeSingle blooddraw>300 genes, MSI, bTMB, Tumour FractionFDA<2 weeks

Genes and genomic signatures

FoundationOne Liquid CDx reports >300 genes and is able to detect both novel and known variants, including four classes of genomic alterations (base substitutions, insertions or deletions, copy number alterations and gene rearrangements), genomic signatures (MSl, bTMB) and Tumour Fraction, to provide prognostic, diagnostic and predictive insights that inform research or treatment decisions for individual patients across all solid tumours.‡1,2

Base SubstitutionsInsertions and deletionsCopy number alterationsRearrangementsMicrosatellite InstabilityMSIbTMBAnalyses>300known cancer-relevant genes%

Assesses all four main classes of genomic alterations* in >300 cancer-related genes, including guideline-recommended genomic alterations associated with available targeted therapies in all solid tumours.1,2,4-11

The FDA-approved liquid biopsy service that reports both MSl and bTMB, pan-tumour genomic signatures that may help inform eligibility for immunotherapy.1-3,19-27

High sensitivity and specificity¥ for key genomic alterations, MSI and bTMB across all solid tumours.1,2

Reports Tumour Fraction, the percentage of tumour-derived circulating cell-free DNA, as a measure of the likelihood of detecting genomic alterations in the liquid biopsy sample.1,2

Faster treatment decisions

Quick and convenient single blood draw helps avoid invasive biopsies and enables faster treatment decisions1,28

FoundationOne Liquid CDx requires only two tubes of blood from a single blood draw (2 x 8.5 ml whole blood) and has a turnaround time of less than 2 weeks from receipt of the sample at our laboratory to report, thereby allowing informed treatment decisions to be made faster.1,28

This may help reduce distress that patients may experience from long waiting times for scheduling a biopsy and receiving the results associated with tissue-based testing.12-15

Potential gain in time to treatment decisionTypical timelines associated with liquid- versus tissue-based CGPLIQUIDTISSUE7 d14 d21 dSample collection and preparation, including biopsy waiting time and shipment28 d35 d

FoundationOne Liquid CDx may also help reduce requirements for healthcare infrastructure and resources compared with tissue-based testing.29
Validation

Based on extensively validated comprehensive platform3,17,18

Like FoundationOne CDx, FoundationOne Liquid CDx is based on an analytically and clinically validated, comprehensive platform and bioinformatics workflow¶1-3,17,18,30
Analytical validationClinical validationBioinformaticsReview and approval of the FoundationOne Liquid CDx platform workflow by the FDA

What is the difference between analytical and clinical validation?

Analytical validationClinical validationWhat does it mean?Ability to detect and measure the presence of a biomarker of interest accurately, reproducibly and reliably26,27

Clinical use in solid cancers

FoundationOne Liquid CDx is suited for all solid tumours including NSCLC, breast cancer, ovarian cancer and prostate cancer1,2,4-11

FoundationOne Liquid CDx covers guideline-recommended, and other clinically relevant genomic alterations and signatures for NSCLC, breast, ovarian and prostate cancer.1,2,4-11,19-25,33-38
EGFRTMBNSCLCBREASTOVARIANPROSTATEBRAFALKROS1HER2 (ERBB2)RETMETNTRK1/2/3MSIESR1NTRK1/2/3BRCA1BRCA2HER2 (ERBB2)PIK3CAMSIBRCA1BRCA2ATMCHEK2MSH2/6PALB2MLH1PMS2RAD51DCDK12FANCAMSIBRCA1BRCA2RAD51BRIP1PALB2MSH2/6PMS2MSIBRCA1

FoundationOne Liquid CDx has demonstrated strong clinical utility

Our previous blood-based comprehensive genomic test demonstrated clinical utility for treatment selection at diagnosis in metastatic NSCLC in BFAST (Blood First Assay Screening Trial), a global, prospective cohort study.30-39
ALK+ prevalenceThe proportion of patients identified as ALK+ using blood-based testing (BFAST) was comparable to that previously reported using tissue-based testing (meta-analysis, range among Western populations)30,40LIQUID5.4%4.5%–6.4%TISSUE

BFAST used an earlier version of Foundation Medicine's current liquid biopsy service, FoundationOne Liquid CDx. The assay used in BFAST for measuring of ALK+ has been incorporated into FoundationOne Liquid CDx. For concordance results between these two tests, please see our full intended use at: www.foundationmedicine.com/F1LCDx.

cfDNA

Sequences circulating cell-free DNA (cfDNA)

FoundationOne Liquid CDx sequences circulating cell-free DNA, which can originate from the primary as well as metastatic tumour sites, thereby capturing the disease heterogeneity across the body as the disease evolves.1,2,14,15
Blood contains circulating cell-free DNA released from healthy tissueand from tumour tissue (circulating tumour DNA, ctDNA)Circulating cells release genomic DNA when lysed(circulating cell-free DNA, cfDNA) Release healthytissue cell-free DNARelease of tumourtissue cell-freeDNA (circulatingtumour DNAor ctDNA)Main source of cell-free DNAApoptosisNecrosis secretionHealthy tissueTumour tissue

In-depth report

A clear, in-depth report provides insights on your patient's genomic profile as well as associated targeted therapies, immunotherapies and relevant clinical trials1,2,4-11,41

Approved targeted therapies and immunotherapies for the patient's genomic alterations and biomarkers are ranked alphabetically within NCCN Categories of Preference (for additional information on the NCCN therapy categories please refer to the NCCN Compendium® at www.nccn.org). Reports vary according to regional differences, e.g. EU reports list EU-approved therapy options to support clinical decision-making.‖41

When using different Foundation Medicine services across the patient journey, consistency of the reports aid comparison of the results.41,42

In-depth reporting & treatment benefits supports clinical decision-making from FoundationOne Liquid CDx cancer testing by Foundation Medicine New Zealand

Order

Order FoundationOne Liquid

Experience how FoundationOne Liquid can open up opportunities with a single blood draw.

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

†309 genes with complete coding exonic coverage, 15 genes with select intronic or non-coding regions only.

‡Foundation0ne Liquid CDx reports MSI-H status

§Validation based on overall >7,500 samples covering >30,000 unique variants across >300 genes and 37 cancer indications.1,2 To learn more about the clinical and analytical validation of FoundationOne Liquid CDx, click here.

¥75 genes are baited with enhanced sensitivity for all variant types (selected based on increased actionability with current or future targeted therapies; for more information of these 75 genes, please refer to our full gene list): other genomic regions are baited with high sensitivity.

¶Clinical validation based on evidence gathered using an earlier version of Foundation Medicine's current liquid biopsy service, FoundationOne Liquid CDx. For concordance results between these two tests, please see our full intended use at: FoundationOneLiquid_CDx_Validation_Summary.pdf.

‖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).

bTMB, blood Tumour Mutational Burden; cfDNA, circulating cell-free DNA; CGP, comprehensive genomic profiling; ctDNA, cell-free tumour DNA; d, days; FDA, US Food and Drug Administration; MSI, Microsatellite Instability; NCCN, National Comprehensive Cancer Network; NGS, next generation sequencing; NSCLC, non-small cell lung cancer.

References
  1. Data on file: FoundationOne Liquid CDx Technical Specifications, 2020.
  2. Woodhouse et al. (2020) Clinical and analytical validation of FoundationOne Liquid CDx, a novel 324-Gene cfDNA-based comprehensive genomic profiling assay for cancers of solid tumor origin. PLoS ONE 15(9): e0237802. https://doi.org/10.1371/journal.pone.0237802.
  3. FoundationOne Liquid CDx FDA Approval, 2020. Available at: https://www.foundationmedicine.com/press-releases/445c1f9e-6cbb-488b-84ad-5f133612b721 (Accessed August 2020).
  4. Planchard D et alAnn Oncol 2019; 30: 863–870.
  5. NCCN Clinical Practice Guidelines in Oncology. Non-Small Cell Lung Cancer. Version 6.2020, June 2020. Available at: https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf (Accessed August 2020).
  6. Cardoso F et al. Ann Oncol 2019; 30: 1674.
  7. NCCN Clinical Practice Guidelines in Oncology. Breast Cancer. Version v4.2021, June 2021. Available at: https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf (Accessed June 2021).
  8. NCCN Clinical Practice Guidelines in Oncology. Prostate Cancer. Version 2.2020, May 2020. Available at: https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf (Accessed August 2020).
  9. NCCN Clinical Practice Guidelines in Oncology. Ovarian Cancer. Version v1.2021, June 2021. https://www.nccn.org/professionals/physician_gls/pdf/ovarian.pdf (Accessed June 2021).
  10. Colombo N et al. Ann Oncol 2019; 30: 672–705.
  11. Parker C et al. Ann Oncol 2020; doi: 10.1016/j.annonc.2020.06.011. [Epub ahead of print].
  12. Lebel S et al. J Psychosom Res 2003; 55: 437–443.
  13. Hayes Balmadrid MA et alJ Health Psychol 2017; 22: 561–571.
  14. Francis G, Stein S. Int J Mol Sci 2015; 16: 14122–14142.
  15. Siravegna G et alAnn Oncol 2019; 30: 1580–1590.
  16. Data on file: FoundationOne Liquid CDx Specimen Instructions.
  17. FoundationOne®CDx FDA Approval, 2017. Available at: 
    https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170019a.pdf (Accessed August 2020).
  18. FoundationOne CDx Technical Information (FDA Label). Available at: https://www.foundationmedicine.com/test/foundationone-cdx (Accessed May 2021).
  19. Kok M et al. ESMO Open 2019; 4(Suppl 2): e000511. 
  20. Zhao P et al. J Hematol Oncol 2019; 12: 54.
  21. Abida W et al. JAMA Oncol 2019; 5: 471–478.
  22. Mateo J et al. Eur Urol 2017; 71: 417–425.
  23. Gandara DR et alNat Med 2018; 24: 1441–1448.
  24. Socinski M. Ann Oncol 2019; 30(suppl_5): v851–v934.
  25. Khagi Y et al. Clin Cancer Res 2017; 23: 5729–5736.
  26. FDA approves pembrolizumab for adults and children with TMB-H solid tumors, 2020. Available at: https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-pembrolizumab-adults-and-children-tmb-h-solid-tumors (Accessed August 2020).
  27. Marabelle A et al. Ann Oncol. 2019;30(suppl_5):v475-v532.
  28. Data on file: FoundationOne Liquid CDx Specimen Collection Instructions
  29. Arnaud A. Value Health 2016. 19: PCN57.
  30. Gadgeel SM et al. Ann Oncol 2019; 30: S5; v851–v934; presented at ESMO 2019.
  31. Merker JD et al. J Clin Oncol 2018; 36: 1631–1641.
  32. Scheerens H et al. Clin Transl Sci 2017; 10: 84–92.
  33. Conway AM et al. Br J Cancer 2019; 120: 141–153.
  34. Amatu A et al. ESMO Open 2016; 1:e000023.
  35. Pikor LA et al. Lung Cancer 2013; 82: 179–189.
  36. Tsao AS et al. J Thorac Oncol 2016; 11: 613–638.
  37. Sanchez-Vega F et al. Cell 2018; 173: 321–337.e10.
  38. Kroeger PT Jr. et al. Curr Opin Obstet Gynecol 2017; 29: 26–34.
  39. Roche Media Release, BFAST, 30 September 2019. Available at: https://www.roche.com/media/releases/med-cor-2019-09-30c.htm (Accessed August 2020).
  40. Dearden S et al. Ann Oncol 2013; 24: 2371–2376.
  41. Data on file: FoundationOne Liquid CDx sample report, 2021.
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