NRAS Codons 12, 13, 61 Mutations

FFPE (tissue); Aspirate; Other (Tumor Specimen)

For FFPE:                                                       

NEED 1 H&E AND 5 UNSTAINED SLIDES (10 MICRON) sequencially; and Need >20% tumor cells in the marked area for mutation assays        

For Aspirate:                                        

Need Estimation of Total Cells in the Marked Area for Nucleotide Extraction; and Need >20% tumor cells in the marked area for mutation assays

1 H&E AND 5 UNSTAINED SLIDES (5-10 MICRON)

Ambient for FFPE and Aspirate

30 days

Incorrect specimen

Negative

7 days

Pyrosequencing

Molecular Diagnostics

NRAS, NRAS Hot-spot mutations

81311

Oncogenic NRAS mutations have been linked to resistance to anti-EGFR therapies. Test results can predict response to anti-EGFR and MAPK pathway therapies in a variety of malignancies including colorectal cancer and melanoma.
 

Limit of detection: 10% mutant alleles (20% tumor cells).

Genomic DNA is isolated from macro-dissected tumor tissue and amplified for segments of the NRAS gene covering codons 12, 13, and 61. Mutation status for these three codons is determined by pyrosequencing. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

This test was developed and its performance characteristics were determined by UTMB Pathology Molecular Diagnostics Laboratory. It has not been cleared or approved by the U. S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) as qualified to perform high complexity clinical laboratory testing.

References:
https://omim.org/entry/164790

http://atlasgeneticsoncology.org//Genes/NRASID92.html

http://cancer.sanger.ac.uk/cosmic/gene/analysis?ln=NRAS