Overview: Oncomine CML Panel Test
Introduction: The Oncomine CML Panel Test detects chronic myeloid leukemia (CML) mutations to diagnose CML, causing fatigue or weight loss. 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 CML, a chronic blood cancer.

Other Names: CML Panel Assay, BCR-ABL1 Mutation Test.

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

Historical Milestone: CML mutation testing began in the 1980s with BCR-ABL1 discovery. NGS methods improved in the 2010s, enhancing diagnostic precision.

Purpose: Detects CML mutations to diagnose chronic myeloid leukemia, guides treatment, and evaluates patients with fatigue or weight loss.

Test Parameters: 1. CML Mutations

Pretest Condition: No fasting required. Collect whole blood or bone marrow. Report history of fatigue, weight loss, or CML 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 fatigue, weight loss, splenomegaly, or family history of CML. Include current medications, especially tyrosine kinase inhibitors.

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

Procedural Considerations: Uses next-generation sequencing to detect CML mutations (e.g., BCR-ABL1). Results are available in 3-5 days, supporting clinical decisions. Performed in laboratories, often for CML diagnosis.

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

Clinical Significance: Identified mutations confirm CML, guiding tyrosine kinase inhibitor therapy. Negative results may require cytogenetic testing.

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

Additional Supporting Tests: Cytogenetic analysis, FISH, or qPCR to confirm CML diagnosis.

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

References: ASH CML Guidelines, 2023; Blood, Jabbour E, 2022.