Cytochrome P450 2D6 Genotype (CP450)

Test Code

LAB2570

Quest 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 whole blood collected in an EDTA (lavender-top or royal blue-top), ACD solution (yellow-top), sodium heparin (green-top) tube

Minimum Volume

3 mL

Other Acceptable Specimens

Bone marrow collected in an EDTA (lavender or royal blue-top), ACD solution (yellow-top) or sodium heparin (green-top) tube

Instructions

Specimen stability is crucial. Store and ship room temperature immediately. Do not freeze. Extracted DNA: Please call 1-866-GENE-INFO (1-866-436-3463) for additional information.

Transport Container

EDTA (lavender-top) tube

Transport Temperature

Room temperature

Specimen Stability

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

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

Received frozen

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

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

AM Mon and thur sample must be received in lab one day prior to setup.

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 Institute-San Juan Capistrano, CA

33608 Ortega Highway

San Juan Capistrano, CA 92675-2042

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.