Cytochrome P450 Genotype Panel

Transcription

1 DOB: Age: Gender: Visit Number (FIN): Patient Results Client: Physician: ARUP Test Code: Collection Date: 11/29/2016 Received in lab: 11/30/2016 Completion Date: 12/07/2016 Gene Genotype Phenotype Review and Approval CYP2D6 *9/*41* Normal CYP2C9 Neg/Neg Normal CYP2C19 *2/Neg Intermediate CYP3A5 *3/*3 Poor * Two decreased function CYP2D6 alleles were detected. This result predicts the extensive metabolizer phenotype and an activity score estimated at 1 of 2. Recommendation: Guidelines for genotype-based dosing are published by the Clinical Pharmacogenetics Implementation Consortium (CPIC) and can be found at: Test Information Genetic variability in cytochrome P450 enzyme production may influence a patient's metabolism of various drugs. This cytochrome P450 genotype panel investigates scientifically vetted genetic variations in CYP2D6, CYP2C9, CYP2C19, and CYP3A5, which have been determined to be clinically informative. The complete list of genetic variants detected with this test panel and associated background information along with testing methodology is available at (search for test code) or by calling Testing is performed at ARUP Laboratories. See Compliance Statement C: Interpretive Comments Cytochrome P450 (CYP) isozymes are involved in the metabolism of most drugs. CYP-mediated metabolism can activate or inactivate a drug, will influence rates of drug clearance, and affect time to achieve steady-state concentrations. The genotype detected for specific CYP gene variants predicts the CYP metabolic phenotype for a patient. The phenotype predicts ultra-rapid, rapid, normal, intermediate, or poor metabolism per CYP gene. In the supplemental report on the following pages, the "Medication Summary" provides some medication recommendations for a patient with the predicted CYP phenotypes. Medications are listed in three columns based on the estimated tolerance of the patient for those drugs. Standard Precautions when a typical drug response is expected Caution/Info when caution in prescribing or additional information may be helpful in managing this drug Consider Alternatives when changing a drug is recommended Details of the recommendations, including clinical levels of evidence that support the recommendations, are included in the "Medication Report Details." Risks of therapeutic failure and/or adverse drug reactions may be affected by genetic and non-genetic factors that are not detected by this test. These results do not replace the need for therapeutic drug or clinical monitoring. Refer to app.genedose.com for further guidance on drug and dose selection based on patient's genetics, drug regimen, indications, demographics, and lifestyle indicators. Patient Report Patient's supplemental medication recommendations report from Coriell Life Sciences continues on the following pages. ARUP Enhanced Reporting December 07, 2016 page 1 of 11

2 Date of Birth: Gender: Physician: Clinical Evidence Levels Strong Moderate Includes gene-drug pairs approved by the Coriell Institute for Medical Research Pharmacogenomics Advisory Group. Includes gene-drug pairs supported by multiple studies documenting consistent effects of specific genetic variant(s) on clinical outcomes. Includes gene-drug pairs approved by the Dutch Pharmacogenetics Working Group (DPWG) and/or guidelines published in Clinical Pharmacology and Therapeutics by the Clinical Pharmacogenetics Implementation Consortium (CPIC). Includes gene-drug pairs supported by pharmacokinetic, pharmacodynamic, or molecular/cellular functional studies showing consistent effects of genetic variant(s). Includes Drug product information (e.g. This interpretation is based on guidance available in the FDA (Food and Drug Administration) drug label for ABILIFY (10/2013). Includes gene-drug pairs for which potential clinical outcomes are inferred from similar gene-drug interactions approved by the Dutch Pharmacogenetics Working Group (DPWG), and/or guidelines published in Clinical Pharmacology and Therapeutics by the Clinical Pharmacogenetics Implementation Consortium (CPIC), and/or pharmacogenomic reports and submission from the Coriell Institute for Medical Research. Emerging Includes gene-drug pairs supported by published studies of the drug, related drug, or a probing compound of interest involving limited data and/or inconsistent findings. The information contained in this report is intended to be interpreted by a licensed physician or other licensed healthcare professional. This report is not intended to take the place of professional medical advice. Decisions regarding use of prescribed medications must be made only after consulting with a licensed physician or other licensed healthcare professional, and should consider each patient's medical history and current treatment regimen. ARUP Enhanced Reporting December 07, 2016 page 2 of 11

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