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TP53 Somatic Mutation, Prognostic [16515X]
Test Code16515
CPT Codes
81352
Preferred Specimen
6 mL whole blood collected in an EDTA (lavender-top) tube
Minimum Volume
3 mL whole blood • 1 mL bone marrow
Other Acceptable Specimens
3 mL bone marrow collected in an EDTA (lavender-top) tube • Formalin-fixed, paraffin-embedded tissue block
Instructions
Submission of whole blood (preferred): Follow standard whole blood collection procedure. Collect 5-6 mL whole blood samples in an EDTA tube. Blood samples are shipped at room temperature or 4°C. Do not freeze whole blood. Record the draw time; also record sample type on the tube, or block ID on requisition form. Ship immediately to maintain sample stability.
Transport Temperature
Whole blood and bone marrow: Refrigerated (cold packs)
Paraffin block: Room temperature
Paraffin block: Room temperature
Specimen Stability
Whole blood and Bone marrow
Room temperature: 72 hours
Refrigerated: 7 days
Frozen: Unacceptable
Paraffin block
Room temperature: Indefinitely
Refrigerated: Indefinitely
Frozen: Unacceptable
Room temperature: 72 hours
Refrigerated: 7 days
Frozen: Unacceptable
Paraffin block
Room temperature: Indefinitely
Refrigerated: Indefinitely
Frozen: Unacceptable
Methodology
Next Generation Sequencing
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Set up: Tues, Thurs; Report available: 3 days
Reference Range
See Laboratory Report
Clinical Significance
Somatic mutation of the p53 tumor suppressor gene is the most common genetic alteration seen in human cancers, with >50% of adult human tumors bearing inactivating mutations or insertions, deletions in the P53 gene. Wild type p53 prevents genetic instability and participates in the apoptotic response to radiotherapy and chemotherapy. Mutations in P53 gene usually correlate with poor outcome and early recurrence in cancer. This test provides important prognostic and prodictive information for patients with B-CLL, breast cancer, cervical cancer, melanoma or other cancers.