Overview: FoundationOne CDx TestIntroduction: The FoundationOne CDx Test analyzes genomic alterations to guide cancer treatment, targeting tumors causing pain or weight loss. Aligned with 2023 ASCO guidelines, it uses PCR for high specificity, aiding in cancer screening. This test is critical for guiding personalized treatment and improving outcomes in molecular pathology for cancer patients.
Other Names: F1CDx Assay, Comprehensive Genomic Profiling Test.
FDA Status: FDA-approved companion diagnostic, meeting molecular pathology standards for diagnostic accuracy.
Historical Milestone: Genomic profiling began in the 2000s with cancer research. FoundationOne CDx was approved in 2017, with advancements in PCR technology by the 2020s.
Purpose: Guides cancer treatment by identifying genomic alterations in patients with tumors causing pain or weight loss.
Test Parameters: 1. Genomic Alterations
Pretest Condition: No fasting required. Collect tissue or whole blood at any time. Report tumor symptoms and treatment history.
Specimen: 0.5-2 cma³ tissue (sterile container) or 2-5 mL whole blood (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 pain, weight loss, 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 genomic alterations (e.g., mutations, rearrangements). Results are available in 3-5 days, supporting clinical decisions.
Factors Affecting Result Accuracy: Low DNA yield or poor sample quality can affect results. Tumor heterogeneity may impact findings.
Clinical Significance: Identified alterations guide targeted therapies (e.g., EGFR inhibitors). Negative results may require alternative testing.
Specialist Consultation: Consult an oncologist for result interpretation.
Additional Supporting Tests: Biopsy, imaging, or liquid biopsy to confirm genomic findings.
Test Limitations: Tumor heterogeneity may miss alterations. Results require clinical correlation.
References: ASCO Cancer Guidelines, 2023; Journal of Clinical Oncology, Frampton GM, 2022.
