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HelpTest Code NGAMT MayoComplete Acute Myeloid Leukemia, Therapeutic Gene Mutation Panel (FLT3, IDH1, IDH2, TP53), Next-Generation Sequencing, Varies
Ordering Guidance
This test is a subset of the NGSHM / Myeloid Neoplasms, Comprehensive OncoHeme Next-Generation Sequencing, Varies test and focuses more specifically on the gene mutations that are most utilized for therapeutic management of 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, then NGSHM should be considered.
Shipping Instructions
Peripheral blood and bone marrow 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)/Refrigerate/Ambient
Forms
1. Hematopathology Patient Information (T676)
2. If not ordering electronically, complete, print, and send a Hematopathology/Cytogenetics Test Request (T726) with the specimen.
Useful For
Evaluation of acute myeloid leukemia using a focused 4-gene panel at the time of diagnosis, or possibly relapsed or refractory disease, to help guide possible therapeutic approaches
Testing Algorithm
For more information see Acute Myeloid Leukemia: Relapsed with Previous Remission Testing Algorithm
For a list of genes and exons targeted by this test see Targeted Genes Interrogated by Acute Myeloid Leukemia, Therapeutic Gene Mutation Panel (FLT3, IDH1, IDH2, TP53), Next-Generation Sequencing.
Special Instructions
Method Name
Next-Generation Sequencing (NGS)
Reporting Name
AML, 4 Gene, NGS, VSpecimen Type
VariesSpecimen 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 |
Reference Values
An interpretive report will be provided
Interpretation
Detailed variant assessment and interpretive comments will be provided for all reportable genetic alterations.
Clinical Reference
1. National Comprehensive Cancer Network (NCCN): NCCN Guidelines: Acute Myeloid Leukemia. NCCN; Version 2.2022 Available at www.nccn.org/guidelines/guidelines-detail?category=1&id=1411
2. DiNardo CD, Stein EM, de Botton S, et al: Durable remissions with Ivosidenib in IDH1-mutated relapsed or refractory AML. N Engl J Med. 2018 Jun 21;378(25):2386-2398. doi: 10.1056/NEJMoa1716984
3. Stein EM, DiNardo CD, Fathi AT, et al: Molecular remission and response patterns in patients with mutant-IDH2 acute myeloid leukemia treated with enasidenib. Blood. 2019 Feb 14;133(7):676-687. doi: 10.1182/blood-2018-08-869008
4. Dohner H, Estey E, Grimwade D, et al: Diagnosis and management of AML in adults: 2017 ELN recommendations from an international expert panel. Blood. 2017 Jan 26;129(4):424-447. doi: 10.1182/blood-2016-08-733196
5. Smith CC: The growing landscape of FLT3 inhibition in AML. Hematology Am Soc Hematol Educ Program. 2019 Dec 6;2019(1):539-547. doi: 10.1182/hematology.2019000058
6. Daver N, Schlenk RF, Russell NH, Levis MJ: Targeting FLT3 mutations in AML: review of current knowledge and evidence. Leukemia. 2019 Feb;33(2):299-312. doi: 10.1038/s41375-018-0357-9
Day(s) Performed
Monday through Friday
Report Available
16 to 21 daysPerforming 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
81120
81121
81245
81246
81352
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| NGAMT | AML, 4 Gene, NGS, V | In Process |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| MP040 | Specimen Type | 31208-2 |
| 601698 | NGAMT Result | No LOINC Needed |
| 601700 | Pathogenic Mutations Detected | 82939-0 |
| 601699 | Interpretation | 69047-9 |
| 601701 | Clinical Trials | 82786-5 |
| 601702 | Variants of Unknown Signficance | 93367-1 |
| 601703 | Additional Notes | 48767-8 |
| 601704 | Method Summary | 85069-3 |
| 601705 | Disclaimer | 62364-5 |
| 601706 | AML 4 Gene Panel Gene List | 36908-2 |
| 601707 | Reviewed By: | 18771-6 |