Overview: FoundationOne Liquid CDx TestIntroduction: The FoundationOne Liquid CDx Test analyzes circulating tumor DNA to guide cancer treatment, targeting tumors causing fatigue or lumps. Following 2023 ASCO guidelines, it uses PCR for high sensitivity, aiding in cancer screening. This test is critical for guiding personalized treatment and improving outcomes in molecular pathology for cancer patients.
Other Names: F1LCDx Assay, Liquid Biopsy Genomic Test.
FDA Status: FDA-approved companion diagnostic, meeting molecular pathology standards for diagnostic accuracy.
Historical Milestone: Liquid biopsy testing began in the 2010s with ctDNA research. FoundationOne Liquid CDx was approved in 2020, with advancements in PCR by the 2020s.
Purpose: Guides cancer treatment by analyzing circulating tumor DNA in patients with tumors causing fatigue or lumps.
Test Parameters: 1. Circulating Tumor DNA
Pretest Condition: No fasting required. Collect whole blood or plasma at any time. Report tumor symptoms and treatment history.
Specimen: 2-5 mL whole blood (EDTA) or 2-4 mL plasma (EDTA). Transport in a biohazard bag within 24 hours.
Sample Stability at Room Temperature: 24 hours
Sample Stability at Refrigeration: 48 hours
Sample Stability at Frozen: Not frozen
Medical History: Document fatigue, lumps, or cancer history. Include current medications, especially chemotherapeutics.
Consent: Written consent required, detailing the tests purpose, diagnostic implications, and potential need for targeted therapy.
Procedural Considerations: Uses PCR to analyze circulating tumor DNA for genomic alterations. Results are available in 3-5 days, supporting clinical decisions.
Factors Affecting Result Accuracy: Low ctDNA levels or poor sample quality can affect results. Tumor shedding variability may impact findings.
Clinical Significance: Identified alterations guide targeted therapies. Negative results may require tissue biopsy.
Specialist Consultation: Consult an oncologist for result interpretation.
Additional Supporting Tests: Tissue biopsy, imaging, or other genomic tests to confirm findings.
Test Limitations: Low ctDNA levels may miss alterations. Results require clinical correlation.
References: ASCO Cancer Guidelines, 2023; Journal of Clinical Oncology, Frampton GM, 2022.
