FoundationOne® CDx
Companion Diagnostic
FoundationOne® CDx is an FDA-approved companion diagnostic used to help identify patients who may be eligible for targeted therapies.
Use
FoundationOne®CDx is designed to provide physicians with clinically actionable information to consider appropriate therapies for patients and understand results with evidence of resistance based on the individual genomic profile of each patient’s cancer. It is the first FDA-approved tissue-based broad companion diagnostic (CDx) clinically and analytically validated for all solid tumors, helping inform decisions for therapy via comprehensive genomic profiling.
Special Instructions
PD-L1 Immunohistochemistry (IHC) testing can be ordered as an optional add-on test. When “Portfolio Reflex” is selected on the test requisition form, Foundation Medicine will proceed with the initial test and if the specimen does not meet the criteria for successful testing, they will automatically reflex to the other test and procure a new specimen. Nearly 9 out of 10 patients pay $0 for testing according to Foundation Medicine's data.
Limitations
Use of the test does not guarantee a patient will be matched to a treatment or that all relevant genomic alterations will be detected. A negative result does not rule out the presence of an alteration. Patients who test negative for companion diagnostic mutations should be reflexed to tumor tissue testing with confirmation using an FDA-approved test, if feasible. Some patients may require a biopsy which may pose a risk.
FDA ApprovedCompanion Diagnostic
Methodology
NGS (CGP)
Biomarkers
Result Turnaround Time
8 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
1 FFPE tissue block + 1 H&E slide (~1 mm³ tissue volume)
Minimum Volume
Minimum Tissue Surface Area - ≥ 25 mm²
Container
FFPE tissue block or 10 unstained slides
Collection Instructions
Tissue fixed in 10% neutral buffered formalin (6–72 hours). Specimen should contain ≥20% tumor nuclei (30% optimal) and be submitted as an FFPE tissue block or 10 unstained slides.
Other tests from different labs that may be relevant