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CYP2C19 Rapid Genotyping Test
Clinical Genetic Test
Help
offered by
RPRD Diagnostics, LLC
GTR Test Accession: Help GTR000593837.1
CAP
PHARMACOGENOMIC
Registered in GTR: 2021-08-23
View version history
Last annual review date for the lab: 2023-11-30 LinkOut
At a Glance
Test purpose: Help
Drug Response; Therapeutic management
Conditions (11): Help
Citalopram response; Clopidogrel response; Escitalopram response more...
Analytes (12): Help
*10; *17; *2; *3; *35 more...
Methods (1): Help
Molecular Genetics - Targeted variant analysis: SNP Detection
Target population: Help
Not provided
Clinical validity: Help
Not provided
Clinical utility: Help
Guidance for selecting a drug therapy and/or dose
Ordering Information
Offered by: Help
RPRD Diagnostics, LLC
View lab's website
Test short name: Help
CYP2C19
Specimen Source: Help
Who can order: Help
  • Genetic Counselor
  • Health Care Provider
  • Licensed Physician
  • Nurse Practitioner
Test Order Code: Help
CYP2C19
View other test codes
CPT codes: Help
**AMA CPT codes notice

Copyright: 2023 American Medical Association. All rights reserved.

Lab contact: Help
Ulrich Broeckel, MD, Lab Director
ubroeckel@rprdx.com
414-316-3097
Contact Policy: Help
Laboratory can only accept contact from health care providers. Patients/families are encouraged to discuss genetic testing options with their health care provider.
How to Order: Help
Download the Test Requistion form found on the "How it Works" page.

Acceptable specimen sources are peripheral whole blood, extracted DNA (gDNA), saliva and buccal swab.

Peripheral Whole Blood: 3-5mL in EDTA tube (lavender top). This is our preferred specimen type;
Extracted DNA: 1ug DNA (please …
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Order URL
Test service: Help
Pharmacogenetics
    OrderCode: CYP2C19
Test development: Help
Test developed by laboratory but exempt from FDA oversight (eg. NYS CLEP approved, offered within a hospital or clinic)
Informed consent required: Help
Decline to answer
Pre-test genetic counseling required: Help
Decline to answer
Post-test genetic counseling required: Help
Decline to answer
Recommended fields not provided:
Test strategy
Conditions Help
Total conditions: 11
Condition/Phenotype Identifier
Test Targets
Analytes Help
Total analytes: 12
Analyte Associated Condition
Methodology
Total methods: 1
Method Category Help
Test method Help
Instrument
Targeted variant analysis
SNP Detection
BioRad CFX384
Clinical Information
Test purpose: Help
Drug Response; Therapeutic management
Clinical utility: Help
Guidance for selecting a drug therapy and/or dose
View citations (5)
  • Scott SA, Sangkuhl K, Stein CM, Hulot JS, Mega JL, Roden DM, Klein TE, Sabatine MS, Johnson JA, Shuldiner AR, . Clinical Pharmacogenetics Implementation Consortium guidelines for CYP2C19 genotype and clopidogrel therapy: 2013 update. Clin Pharmacol Ther. 2013;94(3):317-23. doi:10.1038/clpt.2013.105. Epub 2013 May 22. PMID: 23698643.
  • Hicks JK, Bishop JR, Sangkuhl K, Müller DJ, Ji Y, Leckband SG, Leeder JS, Graham RL, Chiulli DL, LLerena A, Skaar TC, Scott SA, Stingl JC, Klein TE, Caudle KE, Gaedigk A, . Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for CYP2D6 and CYP2C19 Genotypes and Dosing of Selective Serotonin Reuptake Inhibitors. Clin Pharmacol Ther. 2015;98(2):127-34. doi:10.1002/cpt.147. Epub 2015 Jun 29. PMID: 25974703.
  • Moriyama B, Obeng AO, Barbarino J, Penzak SR, Henning SA, Scott SA, Agúndez J, Wingard JR, McLeod HL, Klein TE, Cross SJ, Caudle KE, Walsh TJ. Clinical Pharmacogenetics Implementation Consortium (CPIC) Guidelines for CYP2C19 and Voriconazole Therapy. Clin Pharmacol Ther. 2017;102(1):45-51. doi:10.1002/cpt.583. Epub 2017 Apr 18. PMID: 27981572.
  • Hicks JK, Sangkuhl K, Swen JJ, Ellingrod VL, Müller DJ, Shimoda K, Bishop JR, Kharasch ED, Skaar TC, Gaedigk A, Dunnenberger HM, Klein TE, Caudle KE, Stingl JC. Clinical pharmacogenetics implementation consortium guideline (CPIC) for CYP2D6 and CYP2C19 genotypes and dosing of tricyclic antidepressants: 2016 update. Clin Pharmacol Ther. 2017;102(1):37-44. doi:10.1002/cpt.597. Epub 2017 Feb 13. PMID: 27997040.
  • Lima JJ, Thomas CD, Barbarino J, Desta Z, Van Driest SL, El Rouby N, Johnson JA, Cavallari LH, Shakhnovich V, Thacker DL, Scott SA, Schwab M, Uppugunduri CRS, Formea CM, Franciosi JP, Sangkuhl K, Gaedigk A, Klein TE, Gammal RS, Furuta T. Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for CYP2C19 and Proton Pump Inhibitor Dosing. Clin Pharmacol Ther. 2021;109(6):1417-1423. doi:10.1002/cpt.2015. Epub 2020 Sep 20. PMID: 32770672.

Recommended fields not provided:
Clinical validity, Target population, What is the protocol for interpreting a variation as a VUS?, Are family members with defined clinical status recruited to assess significance of VUS without charge?, Will the lab re-contact the ordering physician if variant interpretation changes?, Is research allowed on the sample after clinical testing is complete?, Sample negative report, Sample positive report
Technical Information
Test Platform:
Taqman SNP Genotyping Assays
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
Human gDNA samples were utilized to assess the validity of the assays. The samples used were either gDNA samples purchased from the Coriell Institute or in-house samples. For some rare variants, no genomic DNA samples were available. Custom plasmids containing the DNA sequence of interest were used. Our assay demonstrated … View more
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
Yes

Method used for proficiency testing: Help
Formal PT program

PT Provider: Help
American College of Medical Genetics / College of American Pathologists, ACMG/CAP
Recommended fields not provided:
Test Confirmation, Assay limitations, Description of internal test validation method, Citations for Analytical validity, Description of PT method, Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review: Help
Category: FDA exercises enforcement discretion
Additional Information
Practice guidelines:
Consumer resources:

IMPORTANT NOTE: NIH does not independently verify information submitted to GTR; it relies on submitters to provide information that is accurate and not misleading. NIH makes no endorsements of tests or laboratories listed in GTR. GTR is not a substitute for medical advice. Patients and consumers with specific questions about a genetic test should contact a health care provider or a genetics professional.