BRAF V600 Mutation Analysis

Synonyms	BRAF V600 MUTATION ANALYSIS LAB14285
Cerner Name	HLX BRAF V600 Mutation Analysis Case
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	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 Thyroid, Total 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
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 Laboratories	Northwell Health Laboratories
CPT	81210,88381
PDM	238467
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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