Test directory: CYP2C19

Ordering Code 5843
Test Name CYP2C19
Alias Cytochrome P450 2C19 Genotype
CYP2C19
clopidogrel (Plavix)
Preferred Specimen Whole Blood
Preferred Container EDTA, K2 (Lavender)
Other Specimen/Container Whole Blood in ACD-B (Yellow)
Optimum Volume 3 mL
Transport Requirements Oahu: Refrigerated
Airline: Refrigerated
Specimen Stability Ambient: 3 Days
Refrigerated: 7 Days
Frozen: 30 Days
Rejection Criteria Plasma or serum, Specimens collected in Sodium Heparin or
Lithium Heparin
Avail. Stat NO
Analytic Time 14 Days
Methodology Polymerase Chain Reaction/Fluorescence Monitoring
Reference Lab  ARUP Laboratories

Reference range(s)

The reference ranges listed below are valid on this date of June 1, 2025.
Component Age Male Norm Male Critical Low Male Critical High Female Norm Female Critical High Female Critical Low Units Add'l info
2C19GENO Specimen ALL See report.
CYP2C19 Genotype ALL See report.
CYP2C19 Phenotype ALL See report.
2C19GENO Interpretation ALL

Recommendation...
Recommendation: Guidelines for genotype-based dosing are published by the Clinical Pharmacogenetics Implementation
Consortium (CPIC) and can be found at: https://cpicpgx.org/ and https://www.pharmgkb.org/

BACKGROUND INFORMATION
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 function

Variants Tested: (Variants are numbered according to NM_000769 transcript)
*1: Indicative of no detected targeted variants and an assumption of functional allele. No variants detected is predictive of the *1 functional allele

CYP2C19*2: rs4244285, c.681G>A; rs12769205, c.332-23A>G
CYP2C19*3: rs4986893, c.636G>A
CYP2C19*4A: rs28399504, c.1A>G
CYP2C19*4B: rs28399504, c.1A>G; rs12248560, c.-806C>T
CYP2C19*5: rs56337013, c.1297C>T
CYP2C19*6: rs72552267, c.395G>A
CYP2C19*7: rs72558186, c.819+2T>A
CYP2C19*8: rs41291556, c.358T>C
CYP2C19*9: rs17884712, c. 431G>A
CYP2C19*17: rs12248560, c.-806C>T
CYP2C19*35: rs12769205, c.332-23A>G
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. Publicly 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

This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug
Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes

See report.
Note1
EER CYP2C19 ALL See report.

Note1:


Recommendation: Guidelines for genotype-based dosing are published by the Clinical Pharmacogenetics Implementation
Consortium (CPIC) and can be found at: https://cpicpgx.org/ and https://www.pharmgkb.org/

BACKGROUND INFORMATION
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 function

Variants Tested: (Variants are numbered according to NM_000769 transcript)
*1: Indicative of no detected targeted variants and an assumption of functional allele. No variants detected is predictive of the *1 functional allele

CYP2C19*2: rs4244285, c.681G>A; rs12769205, c.332-23A>G
CYP2C19*3: rs4986893, c.636G>A
CYP2C19*4A: rs28399504, c.1A>G
CYP2C19*4B: rs28399504, c.1A>G; rs12248560, c.-806C>T
CYP2C19*5: rs56337013, c.1297C>T
CYP2C19*6: rs72552267, c.395G>A
CYP2C19*7: rs72558186, c.819+2T>A
CYP2C19*8: rs41291556, c.358T>C
CYP2C19*9: rs17884712, c. 431G>A
CYP2C19*17: rs12248560, c.-806C>T
CYP2C19*35: rs12769205, c.332-23A>G
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. Publicly 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

This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug
Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes

See report..