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Test 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.

Secondary ID

65661

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

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 identifies targets for more accurate therapeutic management of AML.

Method Name

Next-Generation Sequencing (NGS)

Reporting Name

AML, 4 Gene, NGS, V

Specimen Type

Varies

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 a 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

Detailed variant assessment and interpretive comments will be provided for all reportable genetic alterations.

Method Description

Next-generation sequencing (NGS) is performed for the presence of a mutation in targeted regions of the following 4 genes: FLT3, IDH1, IDH2, and TP53. For details regarding the targeted gene regions identified in this test see Targeted Genes Interrogated by Acute Myeloid Leukemia, Therapeutic Gene Mutation Panel  (FLT3, IDH1, IDH2, TP53), Next-Generation Sequencing. This is a laboratory-developed target enriched NGS panel. DNA is extracted from validated specimen sources including peripheral blood and bone marrow. Library preparation for NGS is performed followed by probe hybridization and capture. Sequencing of the final sample library is performed on a NGS instrument. Following bioinformatic processing of the sequencing data, the sequencing results are interpreted to provide a final clinical report. Genomic alterations are called according to human genome reference build GRCh37 (hg19).(Unpublished Mayo method)

Day(s) Performed

Monday through 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. 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