BRAF and RAS Mutation Analysis with Interpretation-AP
| Label Mnemonic: | BRAFRAS |
| Epic code: | LAB8062 |
| Order form: |
Molecular Oncology Requisition Comprehensive Hematopathology Requisition |
| Supply order: | Supply Order Form |
| Billing: | Billing Policies |
| CPT code: | 81403, 81210, 81275, 81276, 81311, G0452-26 |
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.
Instructions:
Submit formalin fixed, paraffin embedded tissue block and an H&E
slide or Fine needle aspirate material including; Pap and Diff quick
stained slide with the requisition. Please include the surgical
pathology report and relevant clinical information in order to
provide correct interpretation of test results.
Transport Instructions:
Formalin-fixed paraffin embedded blocks or slides ship at room
temperature.
Place requisition into outside pocket of bag.
Protect block or slides from excessive heat and ship in cooled container during summer months.
Place requisition into outside pocket of bag.
Protect block or slides from excessive heat and ship in cooled container during summer months.