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CYP2C19 Genotyping Assay: Test Ordering Information

Test Information:
CYP2C19 Genotyping Assay (CMGDL test code 4001)
CPT Codes
83891x1, 83892 x1, 83900 x1, 83901 x1, 88384 x1, 83912-Report & Interpretation For additional information please refer to the CMGDL Indications for Testing
Clinical Sensitivity
-Patients candidate for or undergoing drug therapy with Estimated at 99 and 87 percent in Asians and drugs metabolized by the CYP2C19 isoenzyme; Caucasians respectively, based on the prevalence of - Patients with personal or family history positive for pathogenic allelic variants detected; sensitivity is clinical inefficacy or adverse effects to drugs metabolized Analytical Sensitivity and Specificity
In particular, the test may be indicated if the following 99 percent of analytical sensitivity and specificity. -Clopidogrel (Plavix®)(see “CMGDL Clopidogrel
Test Limitations
Sensitivity Genotyping assay”, test code 4101) -Although 11 alleles are targeted by this assay, due to the -Antidepressants such as Amitriptyline and escitalopram
scarcity of DNA samples for rare (minor) CYP2C19 -Tamoxifen
alleles such the *4, *5, *6, *7, *8, *9, *10, *13 alleles, the CMGDL has clinically validated and determined accuracy Note: the clinical impact of the CYP2C19 genotype is and precision only for the most common alleles, influenced by whether a drug is activated (e.g. clopidogrel, tamoxifen) or inactivated (e.g. amitryptiline, -Additional allelic variants in CYP2C19 (other than the above stated 11 alleles) or other genes will not be Involvement of other metabolic pathways, and other non-genetic factors such as concurrent intake of other -For all the alleles we cannot exclude the possibility of medications may also influence the clinical impact of the rare mutations located in close proximity to the mutations CYP2C19 genotype (see the “Genetics and Clinical tested that could interfere with the genotyping results and be the cause of a diagnostic error such as a false positive or incorrect result or false negative result (eg reporting a *1/*1 genotype in presence of one or two mutated Specimen Requirements
alleles). -Mutation detection is not a substitute for therapeutic drug Collection Tube: Lavender Top Tube /w EDTA
-Non-genetic factors may also affect drug metabolism. Handling: Room Temp- specimen processed within 72
Results of this test should be interpreted in the context of clinical presentation and in consultation with a licensed Turn-Around Times
-This test was developed and its performance determined by the CMGDL. It has not been cleared or approved by the U.S. Food and Drug Administration. This test is used Methodology and Assay Characteristics
for clinical purposes. Pursuant to the requirements of This test is performed using the eSensor® Technology, CLIA ’88, this laboratory has verified the test accuracy a solid-phase electrochemical method for determining the and precision. Genetic testing using the methods applied genotyping status of a defined panel of mutations (read by the CMGDL is expected to be highly accurate. However, the chance of a false positive or a false negative Panel of Alleles Detected
result, due to laboratory errors incurred during any phase This test is validated to detect the most common of the testing, cannot be completely excluded. CYP2C19 alleles, *2, *3, and *17. Additional alleles such the *4, *5, *6, *7, *8, *9, *10, *13 alleles are reported for Related Tests (visit our website at
informational purposes only (see Test Limitations). Clopidogrel Sensitivity CYP2C19 Genotyping assay Clinical Molecular Genetics Diagnostic Laboratory
University of Miami · PO Box 019132 (M860) · Miami, FL 33101 Location: 1501 NW 10 Ave, Biomedical Research Building Room 445 (M860) ·Miami, FL 33136 Ph: 1-305-243-667 Fax: 1-305-243-8368 Email: [email protected]


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Ch 30

CHAPTER 30 Pharmaceutical Products 1. This Chapter does not cover: (a) Foods or beverages (such as dietetic, diabetic or fortified foods, food supplements, tonic beverages and mineral waters)other than nutritional preparations for intravenous administration (Section IV); Plasters specially calcined or finely ground for use in dentistry (heading 2520); Aqueous distillates or aqueou

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