TP53 Somatic Mutation, Prognostic [16515X]

Test Code

16515

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

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

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.

Performing Laboratory

Quest Diagnostics Nichols Institute-San Juan Capistrano, CA

33608 Ortega Highway

San Juan Capistrano, CA 92675-2042

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.