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CYP2C19
3001508
Ordering Recommendation

Assess genetic risk of abnormal drug metabolism for CYP2C19 substrates. May aid in drug selection and dose planning for drugs metabolized by CYP2C19.

Mnemonic
2C19GENO
Methodology
Polymerase Chain Reaction/Fluorescence Monitoring
Performed
Varies
Reported
5-10 days
New York DOH Approval Status
Specimens from New York clients will be sent out to a New York DOH approved laboratory, if possible.
Submit With Order
ARUP Consult®
Disease Topics
Specimen Required
Patient Preparation
 
Collect
Whole Blood: Lavender (EDTA), Pink (K2EDTA), or Yellow (ACD Solution A or B).
Saliva:
Collection Device by DNA Genotek (OCD-100, ARUP Supply #49295) available online through eSupply using ARUP Connect™ or by contacting ARUP Client Services at (800) 522-2787. 
Specimen Preparation
Transport 3 mL whole blood. (Min: 1 mL) OR Transport the Saliva Collection Device. 
Storage/Transport Temperature
Whole Blood: Refrigerated.
Saliva:
Room temperature. 
Unacceptable Conditions
Plasma or serum. Specimens collected in sodium heparin or lithium heparin. 
Remarks
 
Stability
Whole Blood: Ambient: 72 hours; Refrigerated: 1 week; Frozen: 1 month
Saliva:
Ambient: 2 weeks; Refrigerated: Unacceptable; Frozen: Unacceptable 
Reference Interval
By report
Interpretive Data
Background Information for CYP2C19:
Characteristics:
The cytochrome P450 (CYP) isozyme 2C19 is involved in the metabolism of many drugs. Variants in the gene that code for CYP2C19 will influence pharmacokinetics of CYP2C19 substrates, and may predict or explain non-standard dose requirements, therapeutic failure or adverse reactions.
Inheritance:
Autosomal codominant.
Cause:
CYP2C19 gene variants affect enzyme expression or activity.
Variants Tested:
See the Additional Technical Information document.
Clinical Sensitivity:
Drug-dependent.
Methodology
: Polymerase chain reaction (PCR) and fluorescence monitoring.
Analytical Sensitivity and Specificity
: Greater than 99 percent.
Limitations
: Only the targeted CYP2C19 variants will be detected by this panel, and assumptions about phase and content are made to assign alleles. Publically available sources such as the www.pharmvar.org or www.pharmgkb.org provide guidance on phenotype predictions and allele frequencies. Diagnostic errors can occur due to rare sequence variations. Risk of therapeutic failure or adverse reactions with CYP2C19 substrates may be affected by genetic and non-genetic factors that are not detected by this test. This result does not replace the need for therapeutic drug or clinical monitoring.

Please note the information contained in this report does not contain medication recommendations, and should not be interpreted as recommending any specific medications. Any dosage adjustments or other changes to medications should be evaluated in consultation with a medical provider.

Compliance Statement C: For human genetic inheritable conditions and mutations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

Counseling and informed consent are recommended for genetic testing. Consent forms are available online.

Note
Whole blood is the preferred specimen. Saliva samples that yield inadequate DNA quality and/or quantity will be reported as inconclusive if test performance does not meet laboratory-determined criteria for reporting.
Hotline History
View Hotline History
Components
Component Test Code*Component Chart NameLOINC
30015092C19GENO Specimen31208-2
3001510CYP2C19 Genotype57132-3
30015112C19GENO Interpretation50398-7
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
  • 2C19
  • antidepressants
  • clopidogrel (Plavix)
  • CYP2C19
  • Cytochrome P450 2C19 Genotype
  • omeprazole
  • protein pump inhibitors (PPIs)
  • voriconazole