FoundationOne® Liquid CDx
Companion Diagnostic
FoundationOne® Liquid CDx is an FDA-approved companion diagnostic used to help identify patients who may be eligible for targeted therapies.
Use
FoundationOne Liquid CDx is an FDA-approved comprehensive genomic profiling test that analyzes circulating cell-free DNA from a blood sample. It is used for advanced cancer patients with solid tumors to identify genomic alterations and guide targeted therapy options. The test targets over 300 genes and reports on blood tumor mutational burden (bTMB), microsatellite instability high (MSI-H), and tumor fraction values. It also serves as a companion diagnostic to identify patients who may benefit from specific FDA-approved therapies.
Special Instructions
FoundationOne Liquid CDx allows for a blood-based approach to comprehensive genomic profiling, providing an alternative when tissue samples are not available. It enables seamless reflex testing between blood-based and tissue-based tests within the Foundation Medicine portfolio. It requires only two 8.5 mL tubes of blood and offers broad insurance coverage, including national coverage for qualifying Medicare and Medicare Advantage plans.
Limitations
FoundationOne Liquid CDx is designed for use with patients diagnosed with solid tumors and may not detect all possible genomic alterations. While the test offers high sensitivity for short variants and fusions with sufficient ctDNA tumor fraction, low ctDNA levels may require reflex testing to tissue-based assays to uncover actionable alterations. Additionally, the test results as a professional service are not fully reviewed or approved by the FDA.
FDA ApprovedCompanion Diagnostic
Methodology
NGS (CGP)
Biomarkers
Result Turnaround Time
2 weeks
Related Documents
For more information, please review the documents below
Specimen
Whole Blood
Volume
2 tubes of 8.5 mL each
Minimum Volume
Not provided
Collection Instructions
Collect two 8.5 mL tubes of blood for analysis.
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