TP53 Somatic Mutation, Prognostic

TP53 Somatic Mutation, Prognostic

Test Code

16515
81352
CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.
16515
81352
CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.
Not offered in Quest Diagnostics Nichols Institute (IFD) – San Juan Capistrano. Please provide SERVICE AREA INFORMATION to confirm Test Code for the lab that services your account or to find available tests you can order.
In-home collection may be available in your area for purchase through Quest Mobile.

Clinical Significance

TP53 Somatic Mutation, Prognostic - 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.

Test Resources

Clinical Focus

Cutaneous Melanoma: Laboratory Support of Diagnosis and Management

Test Summary

AML Rapid Mutation Panel

Test Details

Methodology

Next Generation Sequencing

Assay Category

This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Reference Range(s)

See Laboratory Report

LOINC® Codes, Performing Laboratory

Service Area must be determined

Methodology

Next Generation Sequencing
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Reference Range(s)

See Laboratory Report
Service Area must be determined

Preferred Specimen(s)

6 mL whole blood collected in an EDTA (lavender-top) tube

Alternative Specimen(s)

Formalin-fixed paraffin embedded tissue submitted in paraffin embedded tissue block • 3 mL bone marrow collected in an EDTA (lavender-top) tube

Collection Instructions

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 and sample type on the tube, or block ID on requisition form. Ship immediately to maintain sample stability.

Transport Container

EDTA (lavender-top) tube

Transport Temperature

Refrigerated (cold packs)

Specimen Stability

  • Whole blood or bone marrow

  • Room temperature: 72 hours
  • Refrigerated: 7 days
  • Frozen: Unacceptable
  • Formalin-fixed paraffin embedded tissue
  • Room temperature: Indefinite
  • Refrigerated: Indefinite
  • Frozen: Unacceptable

Reject Criteria

Received frozen

Setup Schedule, Minimum Volume

Service Area must be determined
6 mL whole blood collected in an EDTA (lavender-top) tube
Formalin-fixed paraffin embedded tissue submitted in paraffin embedded tissue block • 3 mL bone marrow collected in an EDTA (lavender-top) tube
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 and sample type on the tube, or block ID on requisition form. Ship immediately to maintain sample stability.
EDTA (lavender-top) tube
Refrigerated (cold packs)

Whole blood or bone marrow
Room temperature: 72 hours
Refrigerated: 7 days
Frozen: Unacceptable
Formalin-fixed paraffin embedded tissue
 Room temperature: Indefinite
Refrigerated: Indefinite
Frozen: Unacceptable

Received frozen

Service Area must be determined
Not offered in Quest Diagnostics Nichols Institute (IFD) – San Juan Capistrano. Please provide SERVICE AREA INFORMATION to confirm Test Code for the lab that services your account or to find available tests you can order.
In-home collection may be available in your area for purchase through Quest Mobile.
Test Details

Clinical Significance

Test Resources

Reference ranges are provided as general guidance only. To interpret test results use the reference range in the laboratory report.

The CPT codes provided are based on AMA guidance and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

This material contains content from LOINC® (http://loinc.org). The LOINC Table, LOINC Table Core are copyright © 1995-2019, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license.

The tests listed by specialty and category are a select group of tests offered. For a complete list of Quest Diagnostics tests, please adjust the filter options chosen, or refer to our Directory of Services.

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