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Thyroid Cancer Mutation Panel
Test Code90469
CPT Codes
81445
Includes
BRAF Mutation Analysis, Papillary Thyroid Cancer
RAS Mutation Analysis, Thyroid Cancer
RET/PTC Rearrangement, Thyroid Cancer
PAX8/PPAR[gamma] Translocation, Thyroid Cancer
RAS Mutation Analysis, Thyroid Cancer
RET/PTC Rearrangement, Thyroid Cancer
PAX8/PPAR[gamma] Translocation, Thyroid Cancer
Preferred Specimen
Formalin-fixed, paraffin-embedded tissue block
Other Acceptable Specimens
Needle washing (see instructions)
Instructions
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.
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
Methodology
See individual tests
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics Nichols Institute. It has not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Set up: Daily; Report available: 5 days
Reference Range
BRAF Mutation Analysis, Papillary Thyroid Cancer
RAS Mutation Analysis, Thyroid Cancer
RET/PTC Rearrangement, Thyroid Cancer
PAX8/PPAR[gamma] Translocation, Thyroid Cancer
BRAF Mutation | Not detected |
RAS Mutation Analysis, Thyroid Cancer
HRAS Mutation | Not detected |
KRAS Mutation | Not detected |
NRAS Mutation | Not detected |
RET/PTC Rearrangement, Thyroid Cancer
RETPTC1 | Not detected |
RETPTC3 | Not detected |
PAX8/PPAR[gamma] Translocation, Thyroid Cancer
PAX8/PPAR | Not detected |
Clinical Significance
The thyroid mutation panel assesses for all 8 of the most common mutations or rearrangements associated with thyroid neoplasia.
The BRAF codon 600 mutation, and RET/PTC1 and RET/PTC3 rearrangements are highly associated with papillary thyroid cancer, the PAX8-PPAR{gamma} with follicular carcinomas and RAS mutations (in either HRAS, KRAS and NRAS) usually with follicular neoplasms.
See test codes 90477 (BRAF), 90473 (RET/PTC), 90474 (PPAR/PAX8), and 90479 (RAS panel) for individual components.
A thyroid cytology diagnosis code with reflex to molecular, as appropriate, is also available.
The BRAF codon 600 mutation, and RET/PTC1 and RET/PTC3 rearrangements are highly associated with papillary thyroid cancer, the PAX8-PPAR{gamma} with follicular carcinomas and RAS mutations (in either HRAS, KRAS and NRAS) usually with follicular neoplasms.
See test codes 90477 (BRAF), 90473 (RET/PTC), 90474 (PPAR/PAX8), and 90479 (RAS panel) for individual components.
A thyroid cytology diagnosis code with reflex to molecular, as appropriate, is also available.
Performing Laboratory
Quest Diagnostics Nichols Institute |
14225 Newbrook Drive |
Chantilly, VA 20153 |