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FoundationOne®Liquid CDx

What is FoundationOne®Liquid CDx?

FoundationOne Liquid CDx

FoundationOne Liquid CDx is an FDA-approved companion diagnostic that analyzes guideline-recommended genes from a simple blood draw. It is the only FDA-approved blood-based test to analyze over 300 genes—making it the most comprehensive FDA-approved liquid biopsy on the market.* Plus, as a professional service this test reports blood tumor mutational burden (bTMB), microsatellite instability (MSI), and tumor fraction values.

With more targeted therapy options, comprehensive genomic profiling with FoundationOne Liquid CDx can help guide treatment strategies and help predict patient benefit across multiple cancer indications.

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Over 300 genes, bTMB, and MSI-H*

Includes guideline-recommended genes and biomarkers to help guide therapy selection and identify clinical trial options for patients with solid tumors.

2 tubes of blood

Requires only two 8.5mL tubes of blood to identify targeted therapy, immunotherapy, and clinical trial options.

Demonstrated clinical outcomes data

The only FDA-approved blood-based comprehensive genomic profiling test that can identify prostate cancer patients who may respond to Rubraca®.

Indications

Companion Diagnostic Indications

Indications

Biomarker(s) Detected FDA-approved Therapy

ALK rearrangements

Alecensa® (alectinib)

EGFR exon 19 deletions and EGFR exon 21 L858R substitution

Iressa® (gefitinib), Tagrisso® (osimertinib), or Tarceva® (erlotinib)

Biomarker(s) Detected FDA-approved Therapy

BRCA1, BRCA2, ATM alterations

Lynparza® (olaparib)

BRCA1, BRCA2 alterations

Rubraca® (rucaparib)

BIOMARKER(S) DETECTED FDA-APPROVED THERAPY

BRCA1, BRCA2 alterations

Rubraca® (rucaparib)

BIOMARKER(S) DETECTED FDA-APPROVED THERAPY

PIK3CA mutations C420R, E542K, E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R; and H1047L, H1047R, and H1047Y

Piqray® (alpelisib)

Real-life Results

Real-life Results

Learn more about the clinical utility of FoundationOne Liquid CDx in a number of cancer types.

  • SAMPLE REPORT

    Non-small Cell Lung Cancer (NSCLC) EGFR Sample Report

    View a FoundationOne Liquid NSCLC sample report. This report shows results with an EGFR exon 21 L858R substitution detected.

    DOWNLOAD SAMPLE REPORT
  • NSCLC Profiler

    Uncovering Treatment Options for Patients with Non-Small Cell Lung Cancer (NSCLC)

    Our portfolio of tests analyzes genes and biomarkers for relevant alterations in patients with NSCLC, including EGFR, ALK, ROS1, BRAF, NTRK, METex14, PD-L1 and genomic signatures like TMB§ .

    Download NSCLC Profiler
  • BLOG POST

    Liquid Biopsy: From an Improbable Idea, New Potential Emerges

    It’s always been an ambitious concept: By analyzing a patient’s blood, doctors might better understand their individual cancer, and thus better pinpoint what treatment options may be most effective. But yesterday’s ambition has become today’s reality—we’re living in an exciting time for this kind of test, known as liquid biopsy.

    READ FULL BLOG POST
  • PROSTATE PROFILER

    Unlocking New Treatment Options for Patients with Metastatic Prostate Cancer

    Our portfolio of tests analyzes all guideline-recommended genes and biomarkers for relevant alterations in patients with prostate cancer including: BRCA1, BRCA2, ATM, PALB2, FANCA, RAD51D, CHEK2, CDK12, and genomic signatures like MSI.*

    Prostate Profiler

FoundationOne Liquid CDx Resources

Need More Details?

Our client services team is here to help, Monday through Friday 8AM – 8PM EST. 

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Additional Notes

*FoundationOne Liquid CDx is FDA-approved to report substitutions and inDels in 311 genes, including rearrangements and copy number losses only in BRCA1/2. Comprehensive results across all 324 genes, including bTMB, MSI-H status, and tumor fraction are reported in the professional services section of the report. 

MSI status will be reported for samples determined to have high microsatellite instability.

PD-L1 by immunohistochemistry (IHC) can be ordered as a supplemental test and may inform eligibility for several immunotherapies across different cancer types.

§FoundationOne Liquid CDx reports on bTMB

Important Safety Information

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FoundationOne Liquid CDx

FoundationOne®Liquid CDx is for prescription use only and is a qualitative next-generation sequencing based in vitro diagnostic test for advanced cancer patients with solid tumors. The test analyzes 324 genes utilizing circulating cell-free DNA and is FDA-approved to report short variants in 311 genes and as a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com.