Overview: Oncomine AML Panel Test
Introduction: The Oncomine AML Panel Test detects acute myeloid leukemia (AML) mutations to diagnose AML, 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 AML, a rapidly progressing blood cancer.

Other Names: AML Panel Assay, AML Mutation Test.

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

Historical Milestone: AML mutation testing began in the 2000s with FLT3 and NPM1 discoveries. NGS methods improved in the 2010s, enhancing diagnostic precision.

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

Test Parameters: 1. AML Mutations

Pretest Condition: No fasting required. Collect whole blood or bone marrow. Report history of fatigue, bleeding, or AML 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, bruising, infections, or family history of AML. Include current medications, especially chemotherapy agents.

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

Procedural Considerations: Uses next-generation sequencing to detect AML mutations (e.g., FLT3, NPM1). Results are available in 3-5 days, supporting clinical decisions. Performed in laboratories, often for AML diagnosis.

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

Clinical Significance: Identified mutations confirm AML, guiding chemotherapy or targeted therapies like FLT3 inhibitors. 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 AML diagnosis.

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

References: ASH AML Guidelines, 2023; Blood, Döhner H, 2022.