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AccuType®CP, Clopidogrel CYP2C19 Genotype

Test Summary

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 ultra rapid, 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

Aliases

  • N/A

Specimen Collection

Special Instructions

N/A

Preferred Specimen

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

Minimum Volume

2 mL

Instructions

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

Patient Preparation

N/A

Storage

N/A

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

Limitations

N/A

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

Unacceptable Specimens

N/A

Order Code

ACCTCP

EPIC (Premier) Code

LAB4475

Includes

N/A

CPT Code

  • 81225 - This test code is for non-New York patient testing. For New York patient testing
  • use test code 16925.

Billing Code

  • 700000

CPT Statement

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 the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

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.

Testing Laboratory

Quest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano CA, 92675

Reference Range

See Laboratory Report

Setup Schedule / Expected Turnaround Time

Tuesday, Friday; Report available: 4 - 8 days

Specimen Collection

Special Instructions

N/A

Preferred Specimen

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

Minimum Volume

2 mL

Instructions

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

Patient Preparation

N/A

Storage

N/A

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

Limitations

N/A

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

Unacceptable Specimens

N/A

Billing

CPT Code

  • 81225 - This test code is for non-New York patient testing. For New York patient testing
  • use test code 16925.

Billing Code

  • 700000

CPT Statement

Result Information

Methodology

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

Testing Laboratory

N/A

Reference Range

See Laboratory Report

Setup Schedule / Expected Turnaround Time

Tuesday, Friday; Report available: 4 - 8 days