FoundationOne®Liquid CDx

Our next-generation, FDA-approved liquid biopsy comprehensive genomic profiling service, a minimally-invasive option, alternative or complementary to FoundationOne CDx, for all patients with solid tumours at optimal times beneficial to their treatment journey.1–3

FoundationOne Liquid CDx

What is FoundationOne Liquid CDx?

Genes and genomic signatures

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
(MSI,‡ 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 MSI and bTMB, pan-tumour biomarkers 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 as a measure of the likelihood of detecting genomic alterations in the liquid biopsy sample.1,2

Faster treatment decisions

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

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

Validation

Validation

Based on FDA-approved comprehensive platform3,17,18

Like FoundationOne CDx, FoundationOne Liquid CDx is based on an analytically and clinically validated, FDA-approved, comprehensive platform and bioinformatics workflow.¶1–3,17,18,30

What is the difference between analytical and clinical validation?

Clinical use in solid cancers

Clinical use in solid cancers

FoundationOne Liquid CDx is suited for all solid tumours including NSCLC, breast cancer, ovarian cancer and prostate cancer among other solid tumours1,2,4–11,19–25,33–38

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

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

cfDNA

Sequences circulating cell-free DNA (cfDNA)

FoundationOne Liquid CDx sequences circulating cell-free DNA (cfDNA), 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

In-depth report

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 gene alterations and genomic signatures are ranked alphabetically within NCCN therapy categories (for additional information on the NCCN 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.ǁ41

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

ORDERING

Ordering

Order FoundationOne Liquid CDx

Experience how FoundationOne Liquid CDx can support current and future personalised clinical decisions at optimal times beneficial to your patients’ treatment journeys.1–3

*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.
 

FoundationOne Liquid CDx reports MSI-H status.

 

§Validation based on overall >7500 samples covering >30,000 unique variants across >300* genes and 37 cancer indications. Clinical validation demonstrated concordance with the following diagnostics: cobas® EGFR Mutation Test v2, a tumour tissue polymerase chain reaction-based clinical trial assay (CTA), and an externally validated circulating cell-free DNA-based next-generation sequencing assay. 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; d, days; FDA: US Food and Drug Administration; MSI, Microsatellite Instability; NCCN, National Cancer Center Network; NSCLC, non-small cell lung cancer.

Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine®, Inc. Roche is the licensed distributor of Foundation Medicine® products outside of the United States.