AccuType® CP, Clopidogrel CYP2C19 Genotype

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: sodium heparin (green-top), or ACD-A (yellow-top), or EDTA (lavender-top) pediatric tube • Minimum: 1 mL saliva collected in an Oragene DNA self-collection kit

Instructions
Whole blood: 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

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

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

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.
This test is performed pursuant to a license agreement with Orchid Biosciences, Inc.

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(R)] 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 metoblizers (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 who were receiving clopidogrel treatment (N Engl J Med. 2009; 360:363-375).

Performing Laboratory
Quest Diagnostics Nichols Institute San Jucn Capistrano
33608 Ortega Hwy
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.