Back to MPLN Home Client Services: +1 865.380.9746

TP53 Mutation Analysis

Test ID: M TP53 CPT Code: 81351
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
This assay detects somatic TP53 mutations in exons 2–11. NCCN guidelines recommend TP53 mutation analysis for prognostic and therapy determination in CLL. Patients with TP53 mutations have a an unfavorable prognosis and are resistant to chemoimmunotherapy. Ibrutinib is an FDA-approved BTK inhibitor that can be used for TP53 mutated CLL.
Requisition Forms
Oncology Pathology Requisition

Specimen Requirements

Specimen Requirements
  • Whole Blood: 5mL (minimum 3mL), EDTA preferred (NaHep accepted)
  • Bone Marrow Aspirate: 3mL (minimum 1mL), EDTA preferred (NaHep accepted)
  • Fresh or Frozen Tissue: 5 mm3, Sterile container with 2-4 mL RPMI transport media
  • Paraffin Embedded Tissue Block: FFPE Block, 10% NBF Fixed
  • Paraffin Embedded Tissue Slides: 5 slides or scrolls (minimum 5-10 μM), 10% NBF Fixed
  • Refrigerated or Frozen Extracted DNA: 50 µl at 50 ng/µl
Specimen Stability
  • Whole Blood: 30 Days
  • Bone Marrow Aspirate: 30 Days
  • Fresh Tissue: 96 Hours
  • Paraffin Embedded Tissue Block: Indefinite
  • Paraffin Embedded Tissue Slides: Indefinite
  • 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
  • Fresh Tissue: 2°C to 8°C
  • Paraffin Embedded Tissue Block: 15°C to 25°C
  • Paraffin Embedded Tissue Slides: 15°C to 25°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.
  • Paraffin Embedded Tissue Block: AMBIENT, Use a refrigerated (NOT FROZEN) gel pack in the shipment to protect from extreme temperatures. Separate gel pack from specimen.
  • Paraffin Embedded Tissue Slides: AMBIENT, Use a refrigerated (NOT FROZEN) gel pack in the shipment to protect from extreme temperatures. Separate gel pack from specimen.
Specimen Rejection Criteria

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

Test Details

Keywords
Companion Diagnostics, DNA Sequencing, Next Generation Sequencing
Test Method
Next Generation Sequencing (NGS)
Methodology Category
Molecular
Regulatory Status
RUO
Special Considerations
  • Frozen bone marrow samples are NOT accepted.
  • Paraffin Embedded Tissue Block: FFPE block preferred; unbaked slides acceptable.
  • 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.
Associations

Chronic lymphocytic leukemia/small lymphocytic lymphoma, acute myeloid leukemia, multiple myeloma, solid tumors