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CYP3A4 and CYP3A5
3001518
Ordering Recommendation

Assess genetic risk of abnormal drug metabolism for substrates of CYP3A4 and/or CYP3A5. May aid in drug selection and dose planning for drugs metabolized by CYP3A4 and/or CYP3A5.

Mnemonic
3A4/3A5
Methodology
Polymerase Chain Reaction/Fluorescence Monitoring
Performed
Varies
Reported
5-10 days
New York DOH Approval Status
This test is New York DOH approved.
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 CYP3A4 and CYP3A5:
Characteristics:
The cytochrome P450 (CYP) 3A subfamily of enzymes is involved in metabolism of many drugs. Variants in the genes that code for CYP3A4 and CYP3A5 may influence pharmacokinetics of CYP3A substrates, and may predict or explain non-standard dose requirements, therapeutic failure or adverse reactions.
Inheritance:
Autosomal codominant.
Cause:
CYP3A4 or CYP3A5 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 CYP3A4 and CYP3A5 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 CYP3A 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
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Components
Component Test Code*Component Chart NameLOINC
30015193A4/3A5 Specimen31208-2
3001520CYP3A4 Genotype81139-8
3001521CYP3A5 Genotype81140-6
30015223A4/3A5 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
  • 3A4
  • 3A5
  • CYP3A4
  • CYP3A5
  • Cytochrome P450 3A4
  • Cytochrome P450 3A5
  • tacrolimus