RET/PTC Rearrangement, Thyroid Cancer

Test Code
90473


CPT Codes
81404

Includes
RET/PTC1, RET/PTC3


Preferred Specimen
1 formalin-fixed, paraffin-embedded tissue block


Other Acceptable Specimens
Needle washing (see instructions)


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


Methodology
Real-Time Polymerase Chain Reaction (PCR)

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
Set up: Daily; Report available: 5 days


Reference Range
RET/PTC1Not detected
RET/PTC3Not detected


Clinical Significance
RET/PTC gene fusion is detected in 5-40% of papillary thyroid carcinomas, but has been reported at low frequency in other types of thyroid lesions. Correlation with morphologic and clinical findings is thus required.
The assay tests for both RET/PTC1 and RET/PTC3 rearrangements using a reverse transcription PCR assay. The lower limit of sensitivity is approximately 2.5% mutation-bearing cells in a mixed sample, but can vary due to RNA preservation.


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.