Overview: TSO500 Genomic Profile TestIntroduction: The TSO500 Genomic Profile Test analyzes a broad panel of genes to diagnose cancers, helping guide targeted therapy for abnormal cell growth. Affecting 1 in 100 people with cancer, genomic profiling poses diagnostic challenges due to tumor complexity. Following 2023 National Comprehensive Cancer Network (NCCN) guidelines, it uses next-generation sequencing for high accuracy, supporting molecular pathology screening. This test is essential for diagnosis, treatment planning, and improving outcomes in oncology.
Other Names: TSO500 Cancer Panel Test, Genomic Profiling Assay.
FDA Status: FDA-approved test, meeting pathology standards for diagnostic reliability.
Historical Milestone: TSO500 testing began in the 2010s with research by Illumina, who developed the panel. Next-generation sequencing advancements improved detection, surpassing earlier single-gene tests.
Purpose: Analyzes genomic mutation profile to diagnose cancers, guides targeted therapy, and evaluates patients with cancer history, aiming to manage disease.
Test Parameters: Genomic mutation profile
Pretest Condition: Tissue biopsy required. Collect tissue or whole blood. Report history of cancer.
Specimen: Tissue (FFPE, 0.5-2 cma³), Whole Blood (EDTA, 3-5 mL); Tissue in sterile container. Transport in a biohazard container.
Sample Stability at Room Temperature: 24 hours
Sample Stability at Refrigeration: 48 hours
Sample Stability at Frozen: 1 month
Medical History: Document cancer history. Include current medications or family history.
Consent: Written consent required, detailing the test's purpose, disease risks (e.g., metastasis), and sample collection risks.
Procedural Considerations: Uses next-generation sequencing to analyze mutations, requiring labs with advanced sequencers. Results available in 7-10 days. Performed in labs with strict handling.
Factors Affecting Result Accuracy: Sample degradation or contamination can affect results. Medications may not affect results but require correlation.
Clinical Significance: Mutations suggest cancer type, guiding therapy. Early treatment might improve survival, while untreated cases lead to death. Normal profile may require other tests.
Specialist Consultation: Consult an oncologist for interpretation.
Additional Supporting Tests: Biopsy, imaging, or specific gene tests to confirm diagnosis.
Test Limitations: Broad panel; correlation with clinical status needed. False negatives possible with low tumor content.
References: NCCN Guidelines, 2023; Nature Reviews Cancer, Illumina, 2022.
