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Test Code NGSMY Next-Generation Sequencing for Myeloid Neoplasms

Important Note

This test may require pre-authorization or have limited coverage.  Please check with your appropriate insurance carrier to determine any specific requirements.

Additional Codes

Software Test Code
Label Text NGSMY
EPIC LAB20538

 

Performing Laboratory

NorDx Laboratories

Useful For

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

 

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

 

GENE TARGET LIST

Hotspot genes (28): ABL1,ANKRD26, BRAF, CBL, CSF3R, DDX41,

DNMT3A, FLT3(ITD + TKD), GATA2, HRAS, IDH1, IDH2, JAK2, KIT,

KRAS, MPL, MYD88, NPM1, NRAS, PPM1D, PTPN11, SMC1A, SMC3,

SETBP1, SF3B1, SRSF2, U2AF1, WT1

 

Full genes (17): ASXL1, BCOR, CALR, CEBPA, ETV6, EZH2,

IKZF1, NF1, PHF6, PRPF8, RB1, RUNX1, SH2B3, STAG2, TET2,

TP53, ZRSR2

 

Fusion driver genes (34): ABL1, ABL2, BCL2, BRAF, CCND1,

CREBBP, EGFR, ETV6, FGFR1, FGFR2, FUS, HMGA2, JAK2, KAT6A(MOZ),

KAT6B, KMT2A(MLL), KMT2A-PDTs, MECOM, MET, MLLT10, MRTFA(MKL1),

MYBL1, MYH11, NTRK2, NTRK3, NUP98, NUP214, PAX5, PDGFRA, PDGFRB,

RARA, RUNX1, TCF3, TFE3, ZNF384

 

Expression genes (5): BAALC, MECOM, MYC, SMC1A, WT1

 

For a list of Myeloid DNA Mutations Detected, click here.

 

For a list of Myeloid Gene Fusions Detected, click here.

Method Name

Somatic Mutation Detection by Next-Generation Sequencing (NGS)

 

This assay is a lab developed test established by the NorDx Molecular Pathology Laboratory. This laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical laboratory testing. This test is used for clinical purposes. It should not be regarded as investigational or for research.

Reference Values

An interpretive report will be issued.

Days and Times Test Performed

Weekly.

Report Available

14 - 21 days.

Specimen Type

Submit one of the following:

~Whole blood

~Bone marrow aspirate

Preferred Container

Lavendar Top Tube (EDTA)

Preferred Volume

Whole Blood:  4.0 mL or

Bone Marrow Aspirate:  4.0 mL

Minimum Volume

Collecting minimum volumes can result in a need for sample recollection, and/or a delay in results. Minimum volumes are subjective and cannot account for all aspects of specimen and testing needs. Refer to the Preferred Volume section for optimal volumes for laboratory specimens.

 

Whole Blood:  2.0 mL or

Bone Marrow Aspirate:  2.0 mL

Specimen Stability Information

Specimen Type Temperature Time
DNA extraction - whole blood or bone marrow Refrigerated 14 days
  Ambient 14 days
Specimen Type Temperature Time
RNA extraction - whole blood or bone marrow Refrigerated 7 days
  Ambient 7 days

Do not spin or separate.

Add On Capable

Yes.  See stability requirements.

Advance Beneficiary Notice Requirements

This test, when ordered on Medicare patients, is subject to the National Coverage Determination (NCD) policies. Please verify that the diagnosis code (ICD code) you have chosen demonstrates medical necessity for the test as documented in the physician’s patient record. The CMS web site is available to assist you with this verification. A properly executed Advance Beneficiary Notice (ABN) must be submitted with the specimen if medical necessity is not demonstrated by the ICD code chosen.

CPT Code Information

CPT Code CPT Description CPT Disclaimer
81450

Targeted genomic sequence analysis panel, hematolymphoid neoplasm or disorder, DNA analysis, and RNA analysis when performed, 5-50 genes (eg, BRAF, CEBPA, DNMT3A, EZH2, FLT3, IDH1, IDH2, JAK2, KRAS, KIT, MLL, NRAS, NPM1, NOTCH1), interrogation for sequence variants, and copy number variants or rearrangements, or isoform expression or mRNA expression levels, if performed

  

 

Rejection Information

Dark Green Top Tube (Li Hep)

Clots or Gross Hemolysis

Acceptable Alternative Container(s)

Yellow Top Tube (ACD)

or

LOINC Code Information

31208-2

42349-1

41103-3

69047-9

59465-5