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Test Code NGAML MayoComplete Acute Myeloid Leukemia, 11-Gene Panel, Varies

Secondary ID

65089

Useful For

Evaluation of acute myeloid leukemia using a focused 11-gene panel at the time of diagnosis, or possibly at the time of 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 / MayoComplete Myeloid Neoplasms, Comprehensive OncoHeme Next-Generation Sequencing, Varies 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 whole 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 Information: Ambient (preferred) 14 days/Refrigerate 14 days

Additional Information: To ensure minimum volume and concentration of DNA is met, the requested volume must be submitted. Testing may be canceled if DNA requirements are inadequate.

 

Acceptable:

 

Specimen Type: Whole 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 Information: Ambient (preferred) 14 days/Refrigerate 14 days

Additional Information: To ensure minimum volume and concentration of DNA is met, the requested volume must be submitted. Testing may be canceled if DNA requirements are inadequate.

 

Specimen Type: Extracted DNA from blood or bone marrow

Container/Tube: 1.5 to 2 mL tube

Specimen Volume: Entire specimen

Collection Instructions:

1. DNA must be extracted within 14 days after collection.

2. Label specimen as extracted DNA and source of specimen.

3. Provide volume and concentration of the DNA.

Specimen Stability Information: Frozen (preferred)/Refrigerated/Ambient

Additional Information: DNA must be extracted in a CLIA-certified laboratory or equivalent and must be extracted from a specimen type listed as acceptable for this test (including applicable anticoagulants). We cannot guarantee that all extraction methods are compatible with this test. If testing fails, one repeat will be attempted, and if unsuccessful, the test will be reported as failed and a charge will be applied.


Specimen Minimum Volume

Whole blood, one 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

Reference Values

An interpretive report will be provided

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