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Test ID NGAML Next-Generation Sequencing, Acute Myeloid Leukemia, 11-Gene Panel

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 assist in appropriate classification, prognosis, and therapeutic management of patients

 

Evaluation to determine if a different gene mutation profile is present at the time of AML relapse

Highlights

Next-generation sequencing detection of somatic gene mutations, including type, pattern, and distribution, has diagnostic, prognostic, and potential therapeutic implications for patients with hematologic cancers, such as acute myeloid leukemia (AML).

 

This test enables more accurate classification and prognostic assessment of acute myeloid leukemias (AML).

Testing Algorithm

See Targeted Genes Interrogated by Next-Generation Sequencing, Acute Myeloid Leukemia, 11-Gene Panel in Special Instructions for a list of the genes and exons targeted by this assay.

Method Name

Somatic Mutation Detection by Next-Generation Sequencing (NGS), Hematologic Neoplasms

Reporting Name

Next Gen Sequencing, AML, 11 Gene

Specimen Type

Varies


Advisory Information


This test is a subset of the NGSHM / OncoHeme Next-Generation Sequencing for Myeloid Neoplasms 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 is for a myeloid malignancy other than AML, then NGSHM / OncoHeme Next-Generation Sequencing (NGS), Hematologic Neoplasms should be considered.



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:

 

Specimen Type: Bone marrow aspirate (preferred)

Container/Tube:

Preferred: Lavender top (EDTA) or yellow top (ACD)

Acceptable: Green top (heparin), but not preferred

Specimen Volume: 2 mL

Collection Instructions:

1. Invert several times to mix bone marrow.

2. Send specimen in original tube.

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 (heparin), but not preferred

Specimen Volume: 3 mL

Collection Instructions:

1. Invert several times to mix blood.

2. Send specimen in original tube.

3. Label specimen as blood.

Specimen Stability: Ambient (preferred)/Refrigerate

 

Specimen Type: Extracted DNA from blood or bone marrow

Container/Tube: 1.5-2 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
Varies Varies 14 days

Reference Values

An interpretive report will be provided.

Day(s) and Time(s) Performed

Monday, Wednesday, Friday

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. This test has not been cleared or approved by the U.S. Food and Drug Administration.

CPT Code Information

81450

LOINC Code Information

Test ID Test Order Name Order LOINC Value
NGAML Next Gen Sequencing, AML, 11 Gene In Process

 

Result ID Test Result Name Result LOINC Value
MP038 Specimen Type 31208-2
43554 NGAML Result No LOINC Needed
43488 Pathogenic Mutations Detected 41103-3
43487 Interpretation 69047-9
43489 Clinical Trials 82786-5
43490 Variants of Unknown Significance 82939-0
43491 Additional Notes 48767-8
43492 Method Summary 49549-9
43493 Disclaimer 62364-5
43494 AML Panel Gene List 36908-2
43495 Reviewed By 19139-5

Forms

1. Hematopathology Patient Information (T676) in Special Instructions.

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.