BRAF and RAS Mutation Analysis with Interpretation-AP
| Label Mnemonic: | BRAFRAS |
| Epic code: | LAB8062 |
| Downtime form: | Doctor/Provider Orders - Pathology Molecular |
Molecular Pathology
6240 RCP
384-9568
6240 RCP
384-9568
Specimen(s):
Formalin Fixed, Paraffin Embedded Tissue (FFPET)
Fine Needle Aspirate material including; Pap and Diff quick stained slides
Fine Needle Aspirate material including; Pap and Diff quick stained slides
Rejection Criteria:
Specimens fixed in B5 fixative or that have been decalcified. Tumor
specimens containing less than 50% tumor cells or are less than 10mm2
in area.
Testing Schedule:
Weekdays
Turn Around
Time:
7-10 working days
Reference Range:
Negative
Comments:
This test includes detection of the BRAF V600E, KRAS & NRAS codons
12, 13 and 61, HRAS codon 61 common substitution mutation.
The performance characteristics of this test were determined by the University of Iowa Molecular Pathology 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 for clinical purposes. It should not be regarded as investigational or for research. The laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high complexity clinical laboratory testing.
The performance characteristics of this test were determined by the University of Iowa Molecular Pathology 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 for clinical purposes. It should not be regarded as investigational or for research. The laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high complexity clinical laboratory testing.
Methodology:
PCR amplification followed by single nucleotide primer extension.
Massively parallel Next Generation DNA sequencing by synthesis, semiconductor technology, Ion Personal Genomics Machine.
Massively parallel Next Generation DNA sequencing by synthesis, semiconductor technology, Ion Personal Genomics Machine.
CPT Code:
81403, 81210, 81275, 81276, 81311, G0452-26