Assesses genetic risk of abnormal drug metabolism for CYP2C8 and/or CYP2C9 substrates. May aid in drug selection and dose planning for drugs metabolized by CYP2C8 and/or CYP2C9.
Polymerase Chain Reaction (PCR)/Fluorescence Monitoring
New York DOH Approval Status
Lavender (EDTA), pink (K2EDTA), or yellow (ACD solution A or B).
Transport 3 mL whole blood. (Min: 1 mL)
Plasma or serum. Specimens collected in sodium heparin or lithium heparin. Frozen specimens in glass collection tubes.
Ambient: 72 hours; Refrigerated: 1 week; Frozen: 1 month
Background Information for CYP2C8, CYP2C9, and CYP2C cluster:
Characteristics: The cytochrome P450 (CYP) isozymes 2C8 and 2C9 are involved in the metabolism of many drugs. Variants in the genes that code for CYP2C8 and CYP2C9 may influence pharmacokinetics of substrates, and may predict or explain nonstandard dose requirements, therapeutic failure or adverse reactions. The CYP2C cluster variant (rs12777823) is associated with a decreased warfarin dose requirement in some people of African descent.
Inheritance: Autosomal codominant.
Cause: CYP2C8 and CYP2C9 gene variants and the CYP2C cluster variant affect enzyme function.
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 CYP2C8,CYP2C9, and CYP2C cluster 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 CYP2C8 or CYP2C9 substrates may be affected by genetic and nongenetic 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.
Counseling and informed consent are recommended for genetic testing. Consent forms are available online.
Laboratory Developed Test (LDT)
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.
|Component Test Code*||Component Chart Name||LOINC|
|3004499||CYP2C Cluster Geno||93198-0|
|3004500||CYP2C Cluster Pheno||81259-4|
- CYP2C9 cluster
- Cytochrome P450 2C8
- Cytochrome P450 2C9 Genotype