Test directory: CYP2C19

Ordering Code5843
Test NameCYP2C19
AliasCytochrome P450 2C19 Genotype
CYP2C19
clopidogrel (Plavix)
Preferred SpecimenWhole Blood
Preferred ContainerEDTA, K2 (Lavender)
Other Specimen/ContainerWhole Blood in ACD-B (Yellow)
Optimum Volume3 mL
Transport RequirementsOahu: Refrigerated
Airline: Refrigerated
Specimen StabilityAmbient: 3 Days
Refrigerated: 7 Days
Frozen: 30 Days
Rejection CriteriaPlasma or serum, Specimens collected in Sodium Heparin or
Lithium Heparin
Avail. StatNO
Analytic Time14 Days
MethodologyPolymerase Chain Reaction/Fluorescence Monitoring
Reference Lab ARUP Laboratories

Reference range(s)

The reference ranges listed below are valid on this date of April 23, 2024.
ComponentAgeMale NormMale Critical LowMale Critical HighFemale NormFemale Critical HighFemale Critical LowUnitsAdd'l info
2C19GENO SpecimenALLSee report.
CYP2C19 GenotypeALLSee report.
CYP2C19 PhenotypeALLSee report.
2C19GENO InterpretationALL

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 CYP2C19ALLSee 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..