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HelpTest Code NGAML MayoComplete Acute Myeloid Leukemia, 11-Gene Panel, Varies
Useful For
Evaluation of acute myeloid leukemia (AML) using a focused 11-gene panel at the time of diagnosis or possibly at relapsed/refractory disease to help guide classification and possible therapeutic approaches
Testing Algorithm
For a list of genes and exons targeted by this test see Targeted Genes Interrogated by Acute Myeloid Leukemia, 11-Gene Panel
Special Instructions
Method Name
Next-Generation Sequencing (NGS)
Reporting Name
AML, 11 Gene, NGS, VSpecimen Type
VariesOrdering Guidance
This gene panel is a subset of the NGSHM / Myeloid Neoplasms, Comprehensive OncoHeme Next-Generation Sequencing test and focuses more specifically on the gene mutations that are most prevalent and clinically significant in acute myeloid leukemias (AML). If a wider gene mutation analysis is desired or the indication for testing is for a myeloid malignancy other than AML, consider NGSHM.
Shipping Instructions
Bone marrow and peripheral blood specimens must arrive within 14 days of collection.
Necessary Information
The following information is required:
1. Clinical diagnosis
2. Pertinent clinical history, including disease phase (diagnostic, remission, relapse/refractory) and therapy status (especially if patient has received a hematopoietic stem cell transplant).
3. Clinical or morphologic suspicion
4. Date of collection
5. Specimen source
Specimen Required
Submit only 1 of the following specimens:
Preferred Specimen Type: Bone marrow aspirate
Container/Tube:
Preferred: Lavender top (EDTA) or yellow top (ACD)
Acceptable: Green top (sodium heparin)
Specimen Volume: 2 mL
Collection Instructions:
1. Invert several times to mix bone marrow.
2. Send bone marrow specimen in original tube. Do not aliquot.
3. Label specimen as bone marrow.
Specimen Stability: Ambient (preferred)/Refrigerate
Specimen Type: Peripheral blood
Container/Tube:
Preferred: Lavender top (EDTA) or yellow top (ACD)
Acceptable: Green top (sodium heparin)
Specimen Volume: 3 mL
Collection Instructions:
1. Invert several times to mix blood.
2. Send whole blood specimen in original tube. Do not aliquot.
3. Label specimen as blood.
Specimen Stability: Ambient (preferred)/Refrigerate
Specimen Type: Extracted DNA from blood or bone marrow
Container/Tube: 1.5 to 2 mL tube with indication of volume and concentration of the DNA
Specimen Volume: Entire specimen
Collection Instructions: Label specimen as extracted DNA and source of specimen.
Specimen Stability: Frozen (preferred)/Refrigerated/Ambient
Specimen Minimum Volume
Blood, Bone marrow: 1 mL
Extracted DNA: 100 mcL at 20 ng/mcL concentration
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Varies | Varies | 14 days |
Reject Due To
| Gross hemolysis | Reject |
| Gross lipemia | OK |
| Bone marrow biopsies Slides Paraffin shavings or frozen tissues Paraffin-embedded tissues Paraffin-embedded bone marrow aspirates Moderately to severely clotted |
Reject |
Clinical Information
Next-generation sequencing is a comprehensive molecular diagnostic methodology that can interrogate multiple regions of genomic tumor DNA in a single assay. Many hematologic neoplasms, including acute myeloid leukemia (AML), are characterized by morphologic or phenotypic similarities but can have characteristic somatic mutations in several genes that enable more specific categorization. In addition, many cases of AML lack a clonal cytogenetic finding at diagnosis (normal karyotype) and can be better classified according to gene mutation profile. The presence and pattern of gene mutations in AML can provide critical prognostic information and may help in guiding therapeutic management decisions by physicians, particularly if targeted therapies are available.
Reference Values
An interpretive report will be provided
Interpretation
Day(s) Performed
Monday through Friday
Report Available
16 to 21 daysSpecimen Retention Time
Peripheral blood, bone marrow: 2 weeks; DNA 3 monthsPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Test Classification
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
81450
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| NGAML | AML, 11 Gene, NGS, V | 105343-8 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| MP038 | Specimen Type | 31208-2 |
| 43554 | NGAML Result | No LOINC Needed |
| 43488 | Pathogenic Mutations Detected | 82939-0 |
| 43487 | Interpretation | 69047-9 |
| 43489 | Clinical Trials | 82786-5 |
| 43490 | Variants of Unknown Significance | 93367-1 |
| 43491 | Additional Notes | 48767-8 |
| 43492 | Method Summary | 85069-3 |
| 43493 | Disclaimer | 62364-5 |
| 43494 | AML Panel Gene List | 36908-2 |
| 43495 | Reviewed By | 18771-6 |
Forms
1. Hematopathology Patient Information (T676)
2. If not ordering electronically, complete, print, and send a Hematopathology/Cytogenetics Test Request (T726) with the specimen.
Genetics Test Information
This test includes next-generation sequencing to evaluate for the following 11 genes: CEBPA, DNMT3A, FLT3, IDH1, IDH2, KIT, KRAS, NPM1, NRAS, RUNX1, and TP53.