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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, which has not been reviewed or approved by the FDA, this test reports blood tumor mutational burden (bTMB), microsatellite instability high (MSI-H), 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.
Test Features
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) |
|
MET single nucleotide variants (SNVs) and indels that lead to MET exon 14 skipping |
Tabrecta® (capmatinib) |
| 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) |
FoundationOne Liquid CDx Resources
Resources
View Additional ResourcesReal-life Results
Real-life Results
Learn more about the clinical utility of FoundationOne Liquid CDx in a number of cancer types.
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SAMPLE REPORT
Non-small Cell Lung Cancer (NSCLC) Sample Report
DOWNLOAD SAMPLE REPORTView a FoundationOne Liquid CDx NSCLC sample report. This report shows results with an EGFR exon 21 L858R substitution detected.
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NSCLC Profiler
Uncovering Treatment Options for Patients with Non-Small Cell Lung Cancer (NSCLC)
Download NSCLC ProfilerOur 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.‡
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BLOG POST
Liquid Biopsy: From an Improbable Idea, New Potential Emerges
READ FULL BLOG POSTIt’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.
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PROSTATE PROFILER
Unlocking New Treatment Options for Patients with Metastatic Prostate Cancer
Prostate ProfilerOur 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.§
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SAMPLE REPORT
Prostate Cancer Sample Report
Download Sample ReportView a FoundationOne Liquid CDx prostate cancer sample report. This report shows results with a BRCA2 alteration detected.
Need More Details?
Our client services team is here to help, Monday through Friday 8AM – 8PM EST.
Additional Notes
FoundationOne®Liquid CDx is FDA-approved to report substitutions and indels in 311 genes, including rearrangements in ALK and BRCA1/2 and copy number alterations in BRCA1/2 and ERBB2 (HER2). Comprehensive results across all 324 genes are reported as a laboratory professional service which is not reviewed or approved by the FDA.
*Tarceva® is the registered trademark of OSI Pharmaceuticals, LLC. Iressa®, Lynparza®, and Tagrisso® are registered trademarks of the AstraZeneca group of companies. Piqray® is a registered trademark of Novartis AG Corporation Switzerland. Rubraca® is a registered trademark of Clovis Oncology, Inc.
†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 as a laboratory professional service.
§FoundationOne Liquid CDx only reports MSI when determined to be high
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.