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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

<2 weeks FDASingle blood draw Quick and convenient single blood draw(2 x 8.5 mL whole blood) helps avoid invasive biopsies and enables faster treatment decisions1,12–16 >300 genes, MSI, bTMB, Tumour Fraction Assesses all four main classes of genomic alterations* in >300† cancer-related genes plus MSI, bTMB and Tumour Fraction1,2,4–11FDA-approved Based on our analytically and clinically validated, FDA-approved comprehensive genomic profiling platform and bioinformatics workflow§1–3,17,18 Reflex testingOption of reflex testing to FoundationOne CDx if no actionable genomic alterations are detected in the liquid biopsy sample1,15,18
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 b lood 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

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

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 o f ALK+ has been incorporated into FoundationOne Liquid CDx. For concordance results between these two tests, please see our ful l intended use at:

Sequences circulating cell-free DNA (cfDNA)

FoundationOne Liquid CDx sequences circulating cell-free DNA, which can originate from the primary as well as metastatictumour sites, thereby capturing the disease heterogeneity across the body as the disease evolves.1,2,14,15
Tumour tissueHealthy tissueApoptosisApoptosis Necrosis secretionMain source of cell-free DNA
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 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


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

‡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® (

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.

  1. Data on file: FoundationOne Liquid CDx Technical Specifications, 2020. Available at: (Accessed August 2020).
  2. Data on file: Clinical and analytical validation data file for FoundationOne Liquid CDx.
  3. FoundationOne Liquid CDx FDA Approval, 2020. Available at: (Accessed August 2020).
  4. Planchard D et al. Correction to: "Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up". Ann Oncol; 30: 863–870. 2019
  5. NCCN Clinical Practice Guidelines in Oncology. Non-Small Cell Lung Cancer. Version 6.2020, June 2020. Available at: (Accessed August 2020).
  6. Cardoso F et al. Early breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol; 30: 1674. 2019
  7. NCCN Clinical Practice Guidelines in Oncology. Breast Cancer. Version 5.2020, May 2020. Available at: (Accessed August 2020).
  8. NCCN Clinical Practice Guidelines in Oncology. Prostate Cancer. Version 2.2020, May 2020. Available at: (Accessed August 2020).
  9. NCCN Clinical Practice Guidelines in Oncology. Ovarian Cancer. Version 1.2020, March 2020. (Accessed August 2020).
  10. Colombo N et al. ESMO-ESGO consensus conference recommendations on ovarian cancer: pathology and molecular biology, early and advanced stages, borderline tumours and recurrent disease. Ann Oncol; 30: 672–705.2019
  11. Parker C et al. Association of Bone Metastatic Burden With Survival Benefit From Prostate Radiotherapy in Patients With Newly Diagnosed Metastatic Prostate Cancer. Ann Oncol; doi: 10.1016/j.annonc.2020.06.011. [Epub ahead of print].2020
  12. Lebel S et al. Waiting for a breast biopsy. Psychosocial consequences and coping strategies. J Psychosom Res; 55: 437–443. 2003
  13. Hayes Balmadrid MA et al. Anxiety prior to breast biopsy: Relationships with length of time from breast biopsy recommendation to biopsy procedure and psychosocial factors. J Health Psychol; 22: 561–571. 2017
  14. Francis G, Stein S. Circulating Cell-Free Tumour DNA in the Management of Cancer.. Int J Mol Sci; 16: 14122–14142.2015
  15. Siravegna G et al. How liquid biopsies can change clinical practice in oncology. Ann Oncol; 30: 1580–1590. 2019
  16. Data on file: FoundationOne Liquid CDx Specimen Instructions.
  17. FoundationOne®CDx FDA Approval, 2017. Available at: (Accessed August 2020).
  18. FoundationOne®CDx Technical Specifications, 2018. Available at: (Accessed August 2020).
  19. Kok M et al. How I treat MSI cancers with advanced disease. ESMO Open; 4(Suppl 2): e000511. 2019
  20. Zhao P et al. Mismatch repair deficiency/microsatellite instability-high as a predictor for anti-PD-1/PD-L1 immunotherapy efficacy. J Hematol Oncol; 12: 54. 2019
  21. Abida W et al. Analysis of the Prevalence of Microsatellite Instability in Prostate Cancer and Response to Immune Checkpoint Blockade. JAMA Oncol; 5: 471–478. 2019
  22. Mateo J et al. DNA Repair in Prostate Cancer: Biology and Clinical Implications. Eur Urol; 71: 417–425. 2017
  23. Gandara DR et al. Blood-based tumor mutational burden as a predictor of clinical benefit in non-small-cell lung cancer patients treated with atezolizumab. Nat Med; 24: 1441–1448. 2018
  24. Socinski M. Final efficacy results from B-F1RST, a prospective Phase II trial evaluating blood-based tumour mutational burden (bTMB) as a predictive biomarker for atezolizumab (atezo) in 1L non-small cell lung cancer (NSCLC). Ann Oncol; 30(suppl_5): v851–v934. 2019
  25. Khagi Y et al. Hypermutated Circulating Tumor DNA: Correlation with Response to Checkpoint Inhibitor–Based Immunotherapy. Clin Cancer Res; 23: 5729–5736. 2017
  26. FDA approves pembrolizumab for adults and children with TMB-H solid tumors, 2020. Available at: (Accessed August 2020).
  27. Marabelle A et al. Association of tumor mutational burden with outcomes in patients with select advanced solid tumors treated with pembrolizumab in KEYNOTE-158. Ann Oncol.;30(suppl_5):v475-v532. 2019
  28. Data on file: FoundationOne Liquid CDx Specimen Instructions.
  29. Arnaud A. Costs and Outcomes Comparison of Tissue and Blood Based Biopsies for the Purpose of Biomarker Testing. Value Health. 19: PCN57. 2016
  30. Gadgeel SM et al. Blood Test can Replace Invasive Biopsy for more Patients with Lung Cancer. Ann Oncol; 30: S5; v851–v934; presented at ESMO 2019. 2019
  31. Merker JD et al. Circulating Tumor DNA Analysis in Patients With Cancer: American Society of Clinical Oncology and College of American Pathologists Joint Review. J Clin Oncol; 36: 1631–1641. 2018
  32. Scheerens H et al. Current Status of Companion and Complementary Diagnostics: Strategic Considerations for Development and Launch. Clin Transl Sci; 10: 84–92. 2017
  33. Conway AM et al. Molecular characterisation and liquid biomarkers in Carcinoma of Unknown Primary (CUP): taking the 'U' out of 'CUP'. Br J Cancer; 120: 141–153. 2019
  34. Amatu A et al. NTRK gene fusions as novel targets of cancer therapy across multiple tumour types. ESMO Open; 1:e000023. 2016
  35. Pikor LA et al. Genetic alterations defining NSCLC subtypes and their therapeutic implications. Lung Cancer; 82: 179–189. 2013
  36. Tsao AS et al. Scientific Advances in Lung Cancer 2015. J Thorac Oncol; 11: 613–638. 2016
  37. Sanchez-Vega F et al. Oncogenic Signaling Pathways in The Cancer Genome Atlas. Cell; 173: 321–337.e10. 2018
  38. Kroeger PT Jr. et al. Pathogenesis and heterogeneity of ovarian cancer. Curr Opin Obstet Gynecol; 29: 26–34. 2017
  39. Roche Media Release, BFAST, 30 September 2019. Available at: (Accessed August 2020).
  40. Dearden S et al. Mutation incidence and coincidence in non small-cell lung cancer: meta-analyses by ethnicity and histology (mutMap). Ann Oncol; 24: 2371–2376. 2013
  41. Data on file: FoundationOne Liquid CDx mock report, 2020. 
  42. FoundationOne®CDx Sample Report. Available at: (Accessed August 2020).
  43. FoundationOne®CDx Technical Specifications, 2018. Available at: (Accessed August 2020).