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

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

Quick and convenient single blood draw helps avoid invasive biopsies and enables faster treatment decisions^1,28

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

Based on extensively validated comprehensive platform^3,17,18

What is the difference between analytical and clinical validation?

FoundationOne Liquid CDx is suited for all solid tumours including NSCLC, breast cancer, ovarian cancer and prostate cancer^1,2,4-11

FoundationOne Liquid CDx has demonstrated strong clinical utility

Sequences circulating cell-free DNA (cfDNA)

A clear, in-depth report provides insights on your patient's genomic profile as well as associated targeted therapies, immunotherapies and relevant clinical trials^1,2.4-11,41

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

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^{*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 www.foundationmedicine.com/F1LCDx.}

^{‡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.}