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RAS Mutation Analysis, Thyroid Cancer
Test Code90479
CPT Codes
81403, 81311, 81275, 81276
Includes
HRAS Mutation
KRAS Mutation
NRAS Mutation
KRAS Mutation
NRAS Mutation
Preferred Specimen
1 formalin-fixed, paraffin-embedded tissue block or needle washing
Minimum Volume
1 tissue block or needle washing
Instructions
Do not reject. Needle washings in alcohol-based fixative (e.g. Cytolyt ®) or formalin-fixed, paraffin-embedded tissue block FNA or FFPE specimens are acceptable for the assay. All specimens must be accompanied with pathology report. All FFPE specimens will be examined by a pathologist for confirmation and adequacy. Macrodissection, if warranted, is performed in the lab.
Transport Temperature
Room temperature
Specimen Stability
FNA or FFPE
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable
Needle washings
Room temperature: 30 days
Refrigerated: 30 days
Frozen: Unacceptable
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable
Needle washings
Room temperature: 30 days
Refrigerated: 30 days
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
DO NOT REJECT
Methodology
Pyrosequencing
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Sets up 7 days a week.
Clinical Significance
Activating mutations in the RAS genes, particularly NRAS, have been detected in follicular thyroid carcinomas (up to 40%) and papillary thyroid carcinomas (up to 10%), but are also seen commonly in follicular adenomas. Correlation with morphologic and clinical findings is thus required.