HLX BRAF V600 Mutation Analysis Case HLX BRAF V600 Tracking

Synonyms	BRAF
Allscripts (AEHR) Order Name	BRAF V600 Mutation Analysis
Sunrise Clinical Manager (SCM) Order Name	Not Orderable
EPIC Order Name	BRAF V600 Mutation Analysis
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 Type	Tissue
Specimen Volume	4x5 μm ustained FFPE slides and 1 H&E Slide.
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.
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	238467
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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