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Test Code NGSFX Reanalysis of Acute Myeloid Leukemia 4- or 11- Gene Panels, Additional Genes


Specimen Required


No additional specimen is required. This is a bioinformatics review of additional gene regions not analyzed in the previously ordered NGAMT / Acute Myeloid Leukemia, Therapeutic Gene Mutation Panel (FLT3, IDH1, IDH2, TP53), Next-Generation Sequencing or NGAML / Acute Myeloid Leukemia, 11-Gene Panel. Call 800-533-1710 for assistance with ordering.


Forms

1. Hematopathology Patient Information (T676)

2. If not ordering electronically, complete, print, and send an Hematopathology/Cytogenetics Test Request (T726) with the specimen.

Secondary ID

65718

Useful For

Comprehensive reanalysis of a larger set of genes/gene regions when a more targeted gene panel was previously performed in this laboratory

 

Evaluation of known or suspected hematologic neoplasms, specifically of myeloid origin (eg, acute myeloid leukemia, myelodysplastic syndrome, myeloproliferative neoplasm, myelodysplastic/myeloproliferative neoplasm, unexplained cytopenias) at the time of diagnosis or possibly disease relapse, to help determine diagnostic classification and provide prognostic or therapeutic information for helping guide clinical management

 

Determine the presence of new clinically important gene mutation changes at relapse

Testing Algorithm

Only orderable as a reflex. Reflex testing is available upon request within 6 months of original NGAMT / Acute Myeloid Leukemia, Therapeutic Gene Mutation Panel (FLT3, IDH1, IDH2, TP53), Next Generation Sequencing, Varies or NGAML / Acute Myeloid Leukemia, 11-Gene Panel, Varies sample submission.

 

This is a bioinformatics and variant review only for the added gene regions.

 

For a list of genes and exons targeted by this test see Targeted Genes Interrogated by Myeloid Neoplasms, Comprehensive OncoHeme Next-Generation Sequencing.

Method Name

Only orderable as a reflex. For more information, see:

-NGAMT / Acute Myeloid Leukemia, Therapeutic Gene Mutation Panel (FLT3, IDH1, IDH2, TP53) Next-Generation Sequencing, Varies

-NGAML / Acute Myeloid Leukemia, 11-Gene Panel, Varies.

 

Next-Generation Sequencing (NGS)

Reporting Name

Reanalysis, AML 4 or 11 Gene Panel

Specimen Type

Varies

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Varies 14 days

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 are characterized by morphologic or phenotypic similarities but can have characteristic somatic mutations in many genes that enable more specific categorization. In addition, many myeloid neoplasms lack a clonal cytogenetic finding at diagnosis (normal karyotype) but can be diagnosed or confirmed and classified according to the gene mutation profile. Patients with unexplained cytopenias may harbor acquired genetic alterations in hematopoietic cells (clonal cytopenias of uncertain significance), which may carry the risk of developing overt myeloid malignancies. The presence and pattern of gene mutations in known or suspected myeloid neoplasm can provide critical diagnostic, prognostic, and therapeutic information to help guide management for the patient’s physician.

Reference Values

Only orderable as a reflex. For more information, see:

-NGAMT / Acute Myeloid Leukemia, Therapeutic Gene Mutation Panel (FLT3, IDH1, IDH2, TP53), Next-Generation Sequencing, Varies

-NGAML / Acute Myeloid Leukemia, 11-Gene Panel, Varies.

Interpretation

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

 

If this test is ordered in the setting of erythrocytosis and suspicion of polycythemia vera, interpretation requires correlation with a concurrent or recent prior bone marrow evaluation.

Method Description

This analysis requires either NGAMT / Acute Myeloid Leukemia, Therapeutic Gene Mutation Panel (FLT3, IDH1, IDH2, TP53), Next-Generation Sequencing Varies or NGAML / Acute Myeloid Leukemia, 11-Gene Panel, Varies to have been previously performed at Mayo Clinic Laboratories within the last 6 months. An extended bioinformatics analysis is performed on the original data by a bioinformatics pipeline, and a variant call file is generated for final analysis and reporting of any additional disease-causing variants within genomic target regions present in the larger NGSHM / Myeloid Neoplasms, Comprehensive OncoHeme Next-Generation, Varies.(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

81450

LOINC Code Information

Test ID Test Order Name Order LOINC Value
NGSFX Reanalysis, AML 4 or 11 Gene Panel 99961-5

 

Result ID Test Result Name Result LOINC Value
MP043 Specimen Type 31208-2
NFXID Diagnosis/Indication 29308-4
601695 NGSFX Result No LOINC Needed
601687 Pathogenic Mutations Detected 82939-0
601686 Interpretation 69047-9
601688 Clinical Trials 82786-5
601689 Variants of Unknown Significance 93367-1
601690 Additional Notes 48767-8
601691 Method Summary 85069-3
601692 Disclaimer 62364-5
601693 NGSFX Panel Gene List 36908-2
601694 Reviewed By: 18771-6