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BRAF Mutation Analysis, Papillary Thyroid Cancer

Test Code
90477


CPT Codes
81210

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


Other Acceptable Specimens
Needle washings (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


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Received frozen


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
Setup: Daily; Report available: 5 days


Reference Range
Not detected


Clinical Significance
BRAF V600E mutations are found in 40-50% of papillary thyroid carcinoma (PTC), and much less commonly in anaplastic thyroid carcinoma or poorly differentiated carcinomas involving the thyroid. Correlation with morphologic and clinical findings is thus required.


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.