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).

New York DOH Approval Status

This test is New York state 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

Methodology

Polymerase Chain Reaction (PCR)/Fluorescence Monitoring/Sequencing

Performed

Varies

Reported

5-10 days
If reflexed: 5-7 additional days are required for LR-PCR and sequencing.

Reference Interval

By report

Interpretive Data

Refer to report.

Couseling 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 type. 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. Saliva is only validated for the OpenArray and CNV portions of testing and not the long-range PCR/duplication testing. Long-range PCR/duplication testing will not be performed for saliva samples.

If long-range PCR/duplication testing is performed, additional charges will apply. Approximately less than 5% of samples require 2D6 copy number determination.

Hotline History

N/A

CPT Codes

81225; 81226; 81227; 81230; 81231; 81479; if reflexed, add 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 81259-4
3004499 CYP2C Cluster Geno 101785-4
3004500 CYP2C Cluster Pheno 81259-4
3004504 CYP3A4 Phenotype 81145-5
3004505 CYP3A5 Phenotype 79717-5
3016901 EER CYPP450 Panel 11526-1
* 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

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