Overview: Oncomine Comprehensive Myeloid Panel Test
Introduction: The Oncomine Comprehensive Myeloid Panel Test detects myeloid mutations to diagnose myeloid disorders, causing fatigue or bleeding. Following 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 myeloid disorders, such as AML, MDS, or MPN.

Other Names: Myeloid Panel Assay, Comprehensive Myeloid Test.

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

Historical Milestone: Myeloid mutation testing began in the 2000s with JAK2 and FLT3 discoveries. NGS methods improved in the 2010s, enhancing diagnostic precision.

Purpose: Detects myeloid mutations to diagnose myeloid disorders, guides treatment, and evaluates patients with fatigue or bleeding.

Test Parameters: 1. Myeloid Mutations

Pretest Condition: No fasting required. Collect whole blood or bone marrow. Report history of fatigue, bleeding, or myeloid disorder 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, bleeding, splenomegaly, or family history of myeloid disorders. Include current medications, especially hypomethylating agents.

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

Procedural Considerations: Uses next-generation sequencing to detect myeloid mutations (e.g., JAK2, FLT3). Results are available in 3-5 days, supporting clinical decisions. Performed in laboratories, often for myeloid disorder diagnosis.

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

Clinical Significance: Identified mutations confirm myeloid disorders, guiding targeted therapies or stem cell transplant. Negative results may require bone marrow biopsy.

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 myeloid disorder diagnosis.

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

References: ASH Myeloid Guidelines, 2023; Blood, Papaemmanuil E, 2022.