Melanoma, BRAF V600 Mutation, Cobas®

Melanoma, BRAF V600 Mutation, Cobas®

Test Code

90956
81210
CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.
90956
81210
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 find available tests you can order.
In-home collection is not available in your area through Quest Mobile.

Clinical Significance

Melanoma, BRAF V600 Mutation, Cobas® - This FDA-cleared real-time PCR assay on the cobas 4800 platform assesses for mutations at codon 600 of BRAF, particularly V600E, which are present in 40-60% of melanomas. Melanomas with codon 600 BRAF mutations are associated with response to the BRAF-directed kinase inhibitor vemurafenib (ZELBORAF®).
Tumor DNA is extracted from fixed tumor tissue and subjected to real-time PCR, with approximate sensitivity of 5% mutation-bearing cells in a mixed sample. Other codon 600 BRAF mutations, beside the most common V600E (c.1799T>A) may not be detected by this method.

Test Resources

Clinical Focus

Cutaneous Melanoma: Laboratory Support of Diagnosis and Management

Test Details

Methodology

Real-Time Polymerase Chain Reaction (Cobas®)

Reference Range(s)

Not detected

Alternative Name(s)

B-RAF,Vemurafenib (ZELBORAF®)

LOINC® Codes, Performing Laboratory

Service Area must be determined

Methodology

Real-Time Polymerase Chain Reaction (Cobas®)

Reference Range(s)

Not detected

Alternative Name(s)

B-RAF,Vemurafenib (ZELBORAF®)
Service Area must be determined

Preferred Specimen(s)

Formalin-fixed paraffin embedded tissue

Alternative Specimen(s)

Slides accepted only after contacting Oncology Center as listed in instructions

Collection Instructions

Slides: Please contact the Oncology Center at 1(800)642-4657 x2906, prior to submission of slides for detailed instructions.

Freezing is not recommended for FFPE.

Transport Container

Formalin-fixed paraffin embedded tissue block

Transport Temperature

Room temperature

Specimen Stability

  • Room temperature: Indefinite
  • Refrigerated: Indefinite
  • Frozen: Unacceptable

Reject Criteria

Received frozen

Setup Schedule

Service Area must be determined
Formalin-fixed paraffin embedded tissue
Slides accepted only after contacting Oncology Center as listed in instructions
Slides: Please contact the Oncology Center at 1(800)642-4657 x2906, prior to submission of slides for detailed instructions.

Freezing is not recommended for FFPE.
Formalin-fixed paraffin embedded tissue block
Room temperature
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 find available tests you can order.
In-home collection is not available in your area 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.

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