Wilms Tumor 1 (WT1) Mutation Analysis

Test Code
16896

CPT Codes
81405

Physician Attestation of Informed Consent
This germline genetic test requires physician attestation that patient consent has been received if ordering medical facility is located in AK, DE, FL, GA, IA, MA, MN, NV, NJ, NY, OR, SD or VT or test is performed in MA.

Preferred Specimen
6 mL whole blood collected in an EDTA (lavender-top) tube

Minimum Volume
3 mL whole blood • 1 mL bone marrow

Other Acceptable Specimens
Bone marrow collected in: EDTA (lavender-top) tube

Instructions
Whole blood: Follow standard whole blood collection procedure. Collect 5-6 mL whole blood samples in an EDTA tube. Blood samples are shipped at room temperature or 4° C. Do not freeze whole blood.
Record the draw time; also record sample type on the tube and patient ID on the test requisition. Ship immediately to maintain sample stability.

Transport Temperature
Room temperature

Specimen Stability
Room temperature: 7 days
Refrigerated: 14 days
Frozen: Unacceptable

Methodology
Fragment Analysis • 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
Set up: Mon a.m.; Report available: 5 days

Reference Range
Not detected

Clinical Significance
WT1 mutations occur in up to 15% of patients with AML. Cytogenetically normal acute myeloid leukemia (CN-AML) is the largest subgroup of AML, which represents approximately 45% of adult patients with AML. A WT1 mutation at diagnosis is associated with poor, outcome; it independently predicts a higher risk of relapse when other molecular markers with established prognostic significance and clinical variables are taken into consideration.

Performing Laboratory
Quest Diagnostics Nichols Institute San Juan Capistrano
33608 Ortega Highway
San Juan Capistrano, CA 92675



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.