BRAF V600 Mutation Analysis Build info

Synonyms

• BRAF V600 MUTATION ANALYSIS
• BRAF
• LAB14285

Procedure Name

BRAF V600 MUTATION ANALYSIS

Procedure Master Number

LAB14285

Procedure ID

184820

Clinical Info

ASSAY DESCRIPTION: Mutations in the BRAF gene have been associated with various cancers, including colorectal cancer, malignant
melanoma, thyroid carcinoma, NSCL carcinoma, and adenocarcinoma of the lung. The most frequently reported BRAF mutation is an activating missense
mutation in which the amino acid glutamic acid is substituted for valine at amino acid position 600 (V600E). The BRAF V600 Mutation assay, performed on the Biocartis Idylla™ System using exclusively
FFPE samples (Slides), is an assay for the qualitative detection of V600E/D and V600K/R/M mutations in codon 600 of the BRAF gene.
LIMITATIONS:
This assay is qualitative and is not intended to detect minimal residual disease. Although this assay detects BRAF V600E, V600K, V600R, V600M, and V600D mutations, it does not distinguish between BRAF mutations
occurring on the same nucleotide, i.e., the V600E/D or V600K/R/M mutations. This assay does not detect mutations or alterations in other regions of the BRAF gene. Mutations present below the limit of detection
of the assay (1%) might not be detected.
 

Specimen Sources

Specimen Types

Container

FFPE-Slides  

Collection Instructions

Specimen: 4  unstained 5-um FFPE slides (each with an area 50-600 mm(2) are required. If the tumor content in the tissue is less that 50 % please submit and additional H&E slide for macrodissection.                          

Specimen Volume

4x5 μm ustained FFPE
slides and 1 H&E Slide.

Transport Instructions

Room Temperature

Specimen Stability

Methodology

Qualitative Real-Time PCR performed on the Idylla(TM) platform

Days Performed

Monday - Friday

Performing Laboratory

Northwell Health Laboratories

CPT

81210,88381

PDM

Only Orderable at Locations:

Results

Result Interpretation

Negative for BRAF V600 Mutations

LIMITATIONS: This assay is qualitative and is not intended to detect minimal residual disease. Although this assay detects BRAF V600E, V600K, V600R, V600M, and V600D mutations, it does not distinguish between BRAF mutations occurring on the same nucleotide, i.e., the V600E/D or V600K/R/M mutations.This assay does not detect mutations or alterations in other regions of the BRAF gene. Mutations present below the limit of detection of the assay (1%) might not be detected.

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