Overview: OncoPro Target Focus Liquid Biopsy TestIntroduction: The OncoPro Target Focus Liquid Biopsy Test detects tumor DNA via liquid biopsy to diagnose cancers, causing pain or fatigue. 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 cancers, especially when tissue biopsy is not feasible.
Other Names: Liquid Biopsy Assay, ctDNA Cancer Test.
FDA Status: Laboratory-developed test (LDT), meeting molecular pathology standards for diagnostic accuracy.
Historical Milestone: Liquid biopsy testing began in the 2010s with ctDNA discoveries. NGS methods improved in the 2010s, enhancing diagnostic precision.
Purpose: Detects tumor DNA via liquid biopsy to diagnose cancers, guides treatment, and evaluates patients with pain or fatigue.
Test Parameters: 1. Tumor DNA
Pretest Condition: No fasting required. Collect plasma or serum. Report history of pain, fatigue, or cancer symptoms.
Specimen: Plasma (EDTA, 2-4 mL), Serum (SST, 2-5 mL). Transport in a biohazard container.
Sample Stability at Room Temperature: 24 hours
Sample Stability at Refrigeration: 48 hours
Sample Stability at Frozen: Not frozen
Medical History: Document pain, fatigue, weight loss, or family history of cancer. Include current medications, especially targeted therapies.
Consent: Written consent required, detailing the tests purpose, liquid biopsy implications, and risks of sample collection.
Procedural Considerations: Uses next-generation sequencing to detect circulating tumor DNA (e.g., EGFR, KRAS). Results are available in 3-5 days, supporting clinical decisions. Performed in laboratories, often for cancer diagnosis.
Factors Affecting Result Accuracy: Low ctDNA yield or improper sample storage can affect results. Contamination may reduce specificity.
Clinical Significance: Identified mutations confirm cancer, guiding targeted therapies or monitoring. 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 cancer diagnosis.
Test Limitations: Not all cancers have detectable ctDNA; clinical correlation is needed. Sample quality affects sensitivity.
References: ASCO Liquid Biopsy Guidelines, 2023; Journal of Clinical Oncology, Ignatiadis M, 2022.
