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Myeloid Malignancy NGS Panel

Test ID: M NGS HEME CPT Code: 81450

Expected Turnaround Time
14 days
Stated turn-around-times (TATs) are for clinical use only and subject to change based on biopharma protocol requirements. Final TATs will be specified in the biopharma study contract.

Clinical Information
The Hematologic Neoplasm Testing by NGS assay is designed to identify somatic mutations in 26 genes (ASXL1, CALR, CBL, CEBPA, CSF3R, DNMT3A, EZH2, FLT3 (TKD), IDH1, IDH2, JAK2, KIT, KRAS, MPL, NPM1, NRAS, RUNX1, SETBP1, SF3B1, SRSF2, STAG2, TET2, TP53, U2AF1, WT1, ZRSR2) frequently mutated in myeloid malignancies.

Requisition Forms

Specimen Requirements


Specimen Requirements
  • Whole Blood: 5mL (minimum, 3mL), EDTA preferred (NaHep accepted)
  • Bone Marrow Aspirate: 3mL (minimum 1mL), EDTA preferred (NaHep accepted)
  • Refrigerated Extracted DNA: 50 µl at 50 ng/µl
  • Frozen Extracted DNA: 50 µl at 50 ng/µl

Specimen Stability
  • Whole Blood: 30 days
  • Bone Marrow Aspirate: 30 days
  • Refrigerated Extracted DNA: 60 days
  • Frozen Extracted DNA: Long Term

Storage Requirements
  • Whole Blood: 2°C to 8°C
  • Bone Marrow Aspirate: 2°C to 8°C
  • Refrigerated Extracted DNA: 2°C to 8°C
  • Frozen Extracted DNA: ≤ -15°C

Shipping Recommendations
  • Whole Blood: REFRIGERATED, Protect from extreme temperature with ice pack. Separate ice pack from specimen.
  • Bone Marrow Aspirate: REFRIGERATED, Protect from extreme temperature with ice pack. Separate ice pack from specimen.
  • Refrigerated Extracted DNA: REFRIGERATED, Protect from extreme temperature with ice pack. Separate ice pack from specimen.
  • Frozen Extracted DNA: FROZEN, Ship samples on dry ice. Separate dry ice from specimens. 

Specimen Rejection Criteria

Improper specimen labeling; Insufficient sample volume; Clotted specimen; Specimens beyond stability; Insufficient DNA isolated


Test Details


Keywords
Molecular Diagnostics, Oncology, Lymphoma, Leukemia, Myeloid, Next Generation Sequencing

Test Method
Next Generation Sequencing (NGS)

Methodology Category
Molecular

Regulatory Status
RUO

Special Considerations
  • Frozen blood and bone marrow samples are NOT accepted.
  • Extracted DNA: Isolation of nucleic acids for clinical testing must occur in a CLIA-certified laboratory or a laboratory meeting equivalent requirements. Concentration and volume must be provided for all samples.