Overview: Oncomine Comprehensive Leukemia Panel Test
Introduction: The Oncomine Comprehensive Leukemia Panel Test detects DNA mutations and RNA fusions to diagnose leukemia, causing bleeding or infections. Aligned with 2023 ASH guidelines, it uses PCR for high specificity, supporting cancer screening. This test is critical for guiding diagnosis, treatment planning, and improving outcomes in hematology for patients with suspected leukemia, including AML, ALL, or other subtypes.

Other Names: Leukemia Panel Assay, Comprehensive Leukemia Test.

FDA Status: Laboratory-developed test (LDT), meeting hematology standards for diagnostic accuracy.

Historical Milestone: Comprehensive leukemia testing began in the 2000s with fusion gene discoveries. NGS methods improved in the 2010s, enhancing diagnostic precision.

Purpose: Detects DNA mutations and RNA fusions to diagnose leukemia, guides treatment, and evaluates patients with bleeding or infections.

Test Parameters: 1. Leukemia Mutations and Fusions

Pretest Condition: No fasting required. Collect whole blood or bone marrow. Report history of bleeding, infections, or leukemia symptoms.

Specimen: Whole Blood (EDTA, 2-5 mL), Bone Marrow (EDTA, 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 bleeding, infections, fatigue, or family history of leukemia. Include current medications, especially chemotherapy agents.

Consent: Written consent required, detailing the tests purpose, leukemia implications, and risks of sample collection.

Procedural Considerations: Uses next-generation sequencing to detect leukemia mutations and fusions (e.g., RUNX1, PML-RARA). Results are available in 3-5 days, supporting clinical decisions. Performed in laboratories, often for leukemia diagnosis.

Factors Affecting Result Accuracy: Low DNA/RNA yield or improper sample storage can affect results. Contamination may reduce specificity.

Clinical Significance: Identified mutations/fusions confirm leukemia, guiding chemotherapy or targeted therapies. Negative results may require bone marrow analysis.

Specialist Consultation: Consult a hematologist or oncologist for result interpretation and treatment planning.

Additional Supporting Tests: Bone marrow biopsy, flow cytometry, or cytogenetic analysis to confirm leukemia diagnosis.

Test Limitations: Not all leukemia cases have detectable mutations/fusions; clinical correlation is needed. Sample quality affects sensitivity.

References: ASH Leukemia Guidelines, 2023; Blood, Arber DA, 2022.