AccuType® CP, Clopidogrel CYP2C19 Genotype (NY)

Test Code

CPT Codes
81225<br>This test code is for New York patient testing. For non-New York patient testing, use test code 16924.

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
4 mL whole blood collected in an EDTA (lavender-top) tube

Minimum Volume
2 mL

Other Acceptable Specimens
Whole blood collected in a sodium heparin (green-top), ACD-A (yellow-top), or EDTA (lavender-top) pediatric tube • 1 mL saliva collected in an Oragene DNA self-collection kit

Normal phlebotomy procedure. Specimen stability is crucial. Store and ship immediately.

Transport Temperature
Room temperature

Specimen Stability
Whole blood
Room temperature: 8 days
Refrigerated: 30 days
Frozen: 49 days

Room temperature: 14 days
Refrigerated: 14 days
Frozen: Unacceptable

Real-time 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 the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule
Set up: Tues, Fri; Report available: 4-8 days

Reference Range
See Laboratory Report

Clinical Significance
The cytochrome P450 gene products are responsible for metabolizing a large number of widely prescribed drugs. Clopidogrel (Plavix®) is metabolized by cytochrome P450 2C19 (CYP2C19, S-mephenytoin 4-prime-hydroxylase) to its active form. Poor metabolizers (PM) will require increased dosage to obtain therapeutic levels, while ultra-extensive metabolizers (UM) will require a decreased dosage due to higher than normal rates of drug metabolism. CYP2C19 catalyzes the hydroxylation of a number of clinically important drugs, including omeprazole, proguanil, hexobarbital, imipramine and to a lesser extent, propranolol and diazepam. CYP2C19 loss-of-function alleles were shown to be associated with a higher rate of subsequent cardiovascular events among patients with an acute myocardial infarction and were receiving clopidogrel treatment (N Engl J Med. 2009; 360: 363-375).

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.