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Test Directory Melanoma, BRAF V600 Mutation, Cobas®

Melanoma, BRAF V600 Mutation, Cobas®

Test Summary

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.

Aliases

Specimen Collection

Special Instructions

N/A

Preferred Specimen

Formalin-fixed, paraffin-embedded tissue block

Minimum Volume

N/A

Instructions

N/A

Patient Preparation

N/A

Storage

N/A

Transport Temperature

Room temperature

Specimen Stability

Room temperature: Indefinitely
Refrigerated: Indefinitely
Frozen: Unacceptable

Limitations

N/A

Other Acceptable Specimens

N/A

Unacceptable Specimens

N/A

Order Code

BRAF

EPIC (Premier) Code

LAB6366

Includes

N/A

CPT Code

81210

Billing Code

670594

CPT Statement

Methodology

Real-Time Polymerase Chain Reaction (Cobas^®)

FDA Status

FDA Approved

Physician Attestation of Informed Consent

N/A

Testing Laboratory

Quest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano CA, 92675

Department

Reference Testing

Reference Range

Not detected

Setup Schedule / Expected Turnaround Time

Tuesday, Thursday, Saturday; Report available: 3 days