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AccuType® CP, Clopidogrel CYP2C19 Genotype

Test Code
16924


CPT Codes
81225<br>This test code is for non-New York patient testing. For New York patient testing, use test code 16925.

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


Instructions
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

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: Tues, Fri; Report available: 4-8 days


Reference Range
See Laboratory Report


Clinical Significance

This pharmacogenetic test may be used to help guide clopidogrel prescribing, especially in patients with acute coronary syndrome (ACS) who have undergone percutaneous coronary intervention (PCI) [1]. This test detects common variants in the CYP2C19 gene, the most validated genetic determinant of clopidogrel response.

Clopidogrel is a prodrug that needs to be metabolized to its active form by cytochrome P450 2C19 (CYP2C19). Patients who carry a no-function allele of CYP2C19 have reduced clopidogrel activation, reduced platelet inhibition, and higher risk of major adverse cardiovascular events. Treatment outcomes may be improved in these patients with alternative antiplatelet therapies, such as prasugrel or ticagrelor. Therefore, CYP2C19 genotyping is helpful for assessing an individual's capability to metabolize clopidogrel and optimizing antiplatelet therapy [1].

CYP2C19 genotype classifies individuals as ultrarapid, rapid, normal, intermediate, likely poor, poor, and indeterminate metabolizers. The Clinical Pharmacogenetics Implementation Consortium (CPIC) provides guidelines for using CYP2C19 status to help direct clopidogrel prescribing. Although the association between CYP2C19 genotype and clopidogrel response is most established in patients with ACS who have undergone PCI, growing evidence indicates a similar association in patients with neurovascular indications [1]. The FDA boxed warning indicates diminished antiplatelet effect in CYP2C19 poor metabolizers and availability of tests to identify these individuals [2].

This is a targeted genotyping test and does not detect deletions or novel or rare variants of CYP2C19. CYP2C19 genotype does not identify all the variability in clopidogrel response. Other factors, such as age, body mass index, chronic kidney disease, diabetes mellitus, and concomitant use of certain proton pump inhibitors, may also influence clopidogrel response [1].

The results of this test should be interpreted in the context of pertinent clinical and family history and physical examination findings.

Additional assistance in test selection and interpretation of results is available from our genomic science specialists by calling 1.866.GENE.INFO (1.866.436.3463).

References
1.Lee CR, et al. Clin Pharmacol Ther. 2022;10.1002/cpt.2526.
2. PLAVIX® (clopidogrel bisulfate). Prescribing information. Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership; 2019. Accessed March 5, 2022. https://packageinserts.bms.com/pi/pi_plavix.pdf





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.