Thyroid Cancer Mutation Panel

Test Code

CPT Codes

BRAF Mutation Analysis, Papillary 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)

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
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable

Needle washings
Room temperature: 30 days
Refrigerated: 30 days
Frozen: Unacceptable

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
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.

Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.