Cytochrome P450 2C9 Genotype

Test Code
11294


Alias/See Also
LAB1351


CPT Codes
81227<br />

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) tube


Minimum Volume
3 mL


Other Acceptable Specimens
Whole blood collected in: ACD solution B (yellow-top) tube or sodium heparin (green-top) tube


Instructions
Normal phlebotomy procedure. Specimen stability is crucial. Store and ship room temperature immediately. Do not freeze.


Transport Temperature
Room temperature


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


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

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: Thurs; Report available: 7-14 days


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


Reference Range
See Laboratory Report


Clinical Significance
This assay will detect the two major CYP2C9 alleles associated with poor drug metabolism and resultant drug toxicity or poor therapeutic response and may be used to obtain improved safety and efficacy data from clinical trials and to avoid adverse drug responses in clinical trial participants.


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.