CEBPA Mutation Analysis, Extracted DNA (Client 57774)

Test Code
36315


CPT Codes
81218

Preferred Specimen
0.03 mL Extracted DNA


Minimum Volume
0.03 mL


Instructions
DNA is to be shipped frozen. Do not thaw. Minimum and absolute minimum volume is 0.03 mL. Ship DNA immediately after extraction is performed. DNA must remain frozen until testing.


Transport Temperature
Frozen


Specimen Stability
Room temperature: Unacceptable
Refrigerated: Unacceptable
Frozen: See Instructions


Methodology
Next Generation Sequencing

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 3 days a week. (A.M.). Reports in 3-4 days.


Clinical Significance
The CEBPA gene, a myeloid transcription factor, is mutated
in a subset of acute myeloid leukemia (AML), particularly
those with chromosome analyses showing normal diploid
karyotype Cytogenetically Normal (CN). CN-AML that have
CEBPA mutations show favorable outcome compared to other
groups of CN-AML. Testing for CEBPA mutation, along with
NPM1 (16158 test code) and FLT3 mutations (test code 90574)
is recommended for all patients with CN-AML.




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.