Overview: OncoPro Focus Fusion Panel TestIntroduction: The OncoPro Focus Fusion Panel Test detects fusions in solid tumors to diagnose cancers, causing pain or lumps. Aligned with 2023 ASCO guidelines, it uses PCR for high specificity, supporting cancer screening. This test is critical for guiding diagnosis, treatment planning, and improving outcomes in molecular pathology for patients with suspected solid tumors, such as lung or thyroid cancer.
Other Names: Fusion Panel Assay, Tumor Fusion Test.
FDA Status: Laboratory-developed test (LDT), meeting molecular pathology standards for diagnostic accuracy.
Historical Milestone: Tumor fusion testing began in the 2000s with ALK and ROS1 discoveries. NGS methods improved in the 2010s, enhancing diagnostic precision.
Purpose: Detects fusions in solid tumors to diagnose cancers, guides treatment, and evaluates patients with pain or lumps.
Test Parameters: 1. Tumor Fusion Genes
Pretest Condition: No fasting required. Collect tissue. Report history of pain, lumps, or solid tumor symptoms.
Specimen: Tissue (sterile container, 0.5-2 cma³). Transport in a biohazard container.
Sample Stability at Room Temperature: 7 days
Sample Stability at Refrigeration: Not refrigerated
Sample Stability at Frozen: Not frozen
Medical History: Document pain, lumps, weight loss, or family history of solid tumors. Include current medications, especially targeted therapies.
Consent: Written consent required, detailing the tests purpose, solid tumor implications, and risks of tissue collection.
Procedural Considerations: Uses next-generation sequencing to detect tumor fusions (e.g., ALK, RET). Results are available in 3-5 days, supporting clinical decisions. Performed in laboratories, often for solid tumor diagnosis.
Factors Affecting Result Accuracy: Low RNA yield or improper tissue storage can affect results. Contamination may reduce specificity.
Clinical Significance: Identified fusions confirm solid tumors, guiding targeted therapies like ALK inhibitors. Negative results may require tissue biopsy.
Specialist Consultation: Consult an oncologist for result interpretation and treatment planning.
Additional Supporting Tests: Tissue biopsy, imaging (CT/MRI), or tumor markers to confirm solid tumor diagnosis.
Test Limitations: Not all solid tumors have detectable fusions; clinical correlation is needed. Sample quality affects sensitivity.
References: ASCO Solid Tumor Guidelines, 2023; Journal of Clinical Oncology, Drilon A, 2022.
