Ordering Recommendation

Use to assess genetic risk of abnormal drug metabolism for drugs metabolized by CYP2B6, CYP2C19, CYP2C8, CYP2C9, CYP2D6, CYP3A4, and CYP3A5. May aid in drug selection and dose planning for many drugs. For testing that includes GeneDose access, refer to Cytochrome P450 Genotyping Panel, with GeneDose Access (3004255).

Mnemonic

CYP PANEL

Methodology

Polymerase Chain Reaction/Fluorescence Monitoring/Sequencing

Performed

Varies

Reported

5-10 days

New York DOH Approval Status

This test is New York DOH approved.

Specimen Required

Patient Preparation
Collect

Lavender (K2EDTA), Pink (K2EDTA), or Yellow (ACD Solution A or B).

Specimen Preparation

Transport 3 mL whole blood. (Min: 1 mL)

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

Plasma or serum. Specimens collected in sodium heparin or lithium heparin. Frozen specimens in glass collection tubes.

Remarks
Stability

Ambient: 72 hours; Refrigerated: 1 week; Frozen: 1 month

Reference Interval

By report

Interpretive Data

Background Information for Cytochrome P450 Genotyping Panel:
Characteristics:
The cytochrome P450 (CYP) isozymes 2B6, 2C19, 2C8, 2C9, 2D6 and the CYP3A subfamily are involved in the metabolism of many drugs. Variants in the genes that code for CYP2B6, CYP2C19, CYP2C8, CYP2C9, CYP2D6, CYP3A4, and CYP3A5, and CYP2C cluster (rs12777823) loci, will influence pharmacokinetics of respective substrates, and may predict or explain non-standard dose requirements, therapeutic failure, or adverse reactions.
Inheritance:
Autosomal codominant.
Cause:
Gene variants affect enzyme function.
Variants Tested:
See the Additional Technical Information document.
Clinical Sensitivity:
Drug-dependent.
Methodology:
Polymerase chain reaction (PCR) and fluorescence monitoring. Sequencing is only performed if needed to characterize a duplicated CYP2D6 gene.
Analytical Sensitivity and Specificity:
Greater than 99 percent.
Limitations:
Only the targeted 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. A combination of the CYP2D6*5 (gene deletion) and a CYP2D6 gene duplication cannot be specifically identified; however, this combination is not expected to adversely affect the phenotype prediction. Diagnostic errors can occur due to rare sequence variations. Risk of therapeutic failure or adverse reactions with gene 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.

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

Compliance Category

Laboratory Developed Test (LDT)

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

N/A

CPT Codes

81225; 81226; 81227; 81230; 81231; 81479

Components

Component Test Code* Component Chart Name LOINC
2008926 CYP2D6 Phenotype 79715-9
2008931 CYP2C9 Phenotype 79716-7
2008936 CYP2C19 Phenotype 79714-2
3001503 CYP2C8 Genotype 78972-7
3001504 CYP2C9 Genotype 46724-1
3001510 CYP2C19 Genotype 57132-3
3001515 CYP2D6 Genotype 40425-1
3001520 CYP3A4 Genotype 81139-8
3001521 CYP3A5 Genotype 81140-6
3001525 CYP PANEL Specimen 66746-9
3001526 CYP PANEL Interpretation 50398-7
3004493 CYP2B6 Genotype 72882-4
3004494 CYP2B6 Phenotype 79720-9
3004497 CYP2C8 Phenotype
3004499 CYP2C Cluster Geno
3004500 CYP2C Cluster Pheno 81259-4
3004504 CYP3A4 Phenotype 81145-5
3004505 CYP3A5 Phenotype
* 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

  • CYP2B6
  • CYP2C cluster
  • CYP2C19
  • CYP2C8
  • CYP2C9
  • CYP2D6
  • CYP3A4
  • CYP3A5
  • Cytochrome P450
  • Pharmacogenetics
  • Pharmacogenomics
Cytochrome P450 Genotyping Panel