Inpatient and Outpatient Orderable

BRAF and NRAS Mutation Analysis

Synonyms	BRAF AND NRAS MUTATION ANALYSIS LAB14286 NRAS
Cerner Name	HLX NRAS/BRAF Mutation Analysis Case
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 Sources	Abdomen/Peritoneum Abscess Adenoids Adenoids Adrenal, Left Adrenal, Right Alopecia Amputation Anus Appendix Axilla, Left Axilla, Right Bile Duct Bladder Bone Bone Marrow Brain Breast, Left Breast, Right Bronchial, Left Bronchial, Right Catheter Cervix Colon Diaphragm Duodenum Ear, Left Ear, Right Endocervix Esophagus Extranodal Lymphoid Eye, Left Eye, Right Fallopian Tube, Left Fallopian Tube, Right Foreign Body Gallbladder Hardware/Implants Heart Hepatobiliary Duct Hernia Sac Hydrocele Ileum Jejunum Joint Kidney, Left Kidney, Right Larynx Liver Lung, Left Lung, Right Lymph Node Mandible Maxilla Mediastinum Meninges/Dura Misc Muscle Nail Nasal/Nasopharynx Nerve Ocular Omentum Oropharynx Oropharynx/Throat Ovary, Left Ovary, Right Pancreas Pancreas, Body Pancreas, Head Pancreas, Tail Pancreatic Duct Parathyroid, Left Parathyroid, Right Pelvic Penis Pericardium Pharynx Placenta Pleura, Left Pleura, Right Product of Conception Prostate Rectum Retroperitoneum Salivary Gland, Left Salivary Gland, Right Skin Soft Tissue Spinal Cord Spleen Stoma Stomach Synovium Testis, Left Testis, Right Thyroid, Isthmus Thyroid, Left Thyroid, Right Tongue Tonsil, Left Tonsil, Right Tooth Trachea Ureter, Left Ureter, Right Urethra Urine Uterus Vagina Vas Deferens, Left Vas Deferens, Right Vascular Vulva Wound Deep Wound/Skin Superficial Show more...
Specimen Types	Tissue
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.
Specimen Volume	4x5 μm unstained FFPE slides and 1 H&E Slide.
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
Only Orderable at Locations:	Orderable Everywhere
Results
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.
Forms

LAB14286