HLX NRAS/BRAF Mutation Analysis Case HLX NRAS/BRAF Tracking

Synonyms	NRAS/BRAF
Allscripts (AEHR) Order Name	BRAF and NRAS Mutation Analysis
Sunrise Clinical Manager (SCM) Order Name	Not Orderable
EPIC Order Name	BRAF and NRAS Mutation Analysis
Clinical Info	ASSAY DESCRIPTION: BRAF V600 mutations are associated with sensitivity to BRAF inhibitors while NRAS mutations have a prognostic value. The NRAS/BRAF Mutation assay, performed on the Biocartis Idylla™ System using exclusively FFPE samples (Slides), combines the detection of mutations in codons 12, 13, 59, 61, 117, 146 of the NRAS gene, and mutations in codon 600 (V600E/D/K/R) of the BRAF gene. LIMITATIONS: This assay is qualitative and is not intended to detect minimal residual disease. The assay does not distinguish between some variants for NRAS G13 (G13R/V), NRAS G12 (G12 A/V) and NRAS A146 (A146T/V). While the assay detects BRAF V600E, V600K, V600R and V600D mutations it does not distinguish between the different variant occurring on the same nucleotide, i.e. the V600E/D or V600K/R mutations. Mutations present below the limit of detection of the assay (5%) might not be detected
Specimen Type	Other
Specimen Volume	4x5 μm unstained FFPE slides and 1 H&E Slide.
Container	FFPE-Slides
Collection Instructions	Specimen: 4 unstained 5-um FFPE slides ( each with and area of 50-600mm(2) are required. If the tumor content in the tissue is less than 10%, Please submit an additional H&E slide for microdissection.
Transport Instructions	Room Temperature
Specimen Stability
Methodology	Qualitative Reat-Time PCR performed on the Idylla (TM) platform.
Days Performed	Monday - Friday
Performing Laboratory
CPT	81210,81311,88381
PDM	238470
Result Interpretation Negative for BRAF 600 and the NRAS mutations Limitation: This assay is qualitative and not intended to detect minimal residual disease.The assay does not distinguish between some variants for NRAS G13 (G13R/V), NRAS G12 (G12 A/V) and NRAS A146 (A146T/V). While the assay detects BRAF V600E, V600K, V600R and V600D mutations, it does not distinguish between the different variants occurring on the same nucleotide, i.e. the V600E/D or V600K/R mutations. Mutations present below the limit of detection (5%) may not be detected.
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