Cytochrome P450 2D6 Genotype

Test Code
10490

CPT Codes
81226

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
5 mL EDTA whole blood collected in a: (lavender-top) tube


Minimum Volume
3 mL

Other Acceptable Specimens
5 mL EDTA whole blood collected in a: (dark/royal blue-top) tube • 5 mL ACD whole blood collected in a: (yellow-top, Solution-A, -B) tube • 5 mL Sodium heparin whole blood collected in a: (green-top) tube 

Instructions
Specimen stability is crucial. Store and ship at room temperature immediately. Do not freeze. Sample must be received in lab one day before set up.

Extracted DNA: Please call 1-866-GENE-INFO (1-866-436-3463) for additional information.

Transport Container
EDTA (lavender-top) tube or (dark/royal blue-top) tube • ACD (yellow-top, Solution-A, -B) tube • Sodium heparin (green-top) tube • Plastic, screw-capped, aliquot tube or vial

Transport Temperature
Room temperature

Specimen Stability
Room temperature: 8 days
Refrigerated: 8 days
Frozen: Unacceptable

Methodology
Polymerase Chain Reaction (PCR) • Single Nucleotide Primer Extension Reaction (SNP-IT)

FDA Status

This test was developed and its performance characteristics were determined by Quest Diagnostics. Performance characteristics refer to the analytical performance of the test.

This test is performed pursuant to license agreements with Roche Molecular Systems, Inc., and Orchid Biosciences, Inc.



Setup Schedule
Set up: Mon, Thurs a.m.; Report available: 7 days

Limitations
The metabolism of drugs is influenced by genotype and other factors.

Reference Range
See Laboratory Report

Clinical Significance
The CYP2D6 gene product is responsible for the metabolism of many major drug groups including many antidepressants, neuroleptics, and cardiovascular drugs. Cytochrome 450 2D6 Genotype detects eight alleles associated with the poor metabolizer phenotype (PM). Patients with duplication of the CYP2D6 gene are ultraextensive metabolizers (UEM). Approximately 5-10% of Caucasian individuals express PM phenotype and the same percentage the UEM phenotype.

Performing Laboratory
Quest Diagnostics Nichols Inst San Juan Capistrano
33608 Ortega Highway
San Juan Capistrano, CA 92690-6130



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.