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Test 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

Method Name

Next-Generation Sequencing (NGS)

Reporting Name

AML, 11 Gene, NGS, V

Specimen Type

Varies


Ordering 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

Reference Values

An interpretive report will be provided

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 days

Performing 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.