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Pharmacogenetic Panel
Clinical Genetic Test
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offered by
Sanford Medical Genetics Laboratory
View lab's test page
LinkOut
GTR Test Accession: Help GTR000569522.5
CAP
PHARMACOGENOMICINHERITED DISEASE
Last updated in GTR: 2024-10-25
View version history
Last annual review date for the lab: 2024-10-24 LinkOut
At a Glance
Test purpose: Help
Drug Response
Conditions (5): Help
Drug metabolism or response; Clopidogrel response; Codeine response more...
Genes (14): Help
ABCG2 (4q22.1); CYP2B6 (19q13.2); CYP2C19 (10q23.33); CYP2C9 (10q23.33); CYP2D6 (22q13.2) more...
Methods (1): Help
Molecular Genetics - Targeted variant analysis: Next-Generation (NGS)/Massively parallel sequencing (MPS)
Target population: Help
Individuals with a need for preemptive or reactive pharmacogenetic testing …
Clinical validity: Help
Not provided
Clinical utility: Help
Guidance for selecting a drug therapy and/or dose
Ordering Information
Offered by: Help
Sanford Medical Genetics Laboratory
View lab's test page
Test short name: Help
PGx panel
Specimen Source: Help
Who can order: Help
  • Genetic Counselor
  • Health Care Provider
  • Licensed Physician
  • Nurse Practitioner
  • Physician Assistant
Test Order Code: Help
LBOR0230
View other test codes
CPT codes: Help
**AMA CPT codes notice

Copyright: 2023 American Medical Association. All rights reserved.

Lab contact: Help
Linda Berg, MS, Administrator
[email protected]
(605) 404-4378
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
Call Sanford Client support at (605) 328-5493
Order URL
Test development: Help
Test developed by laboratory (no manufacturer test name)
Informed consent required: Help
Based on applicable state law
Test strategy: Help
Phamacogenomic genes are tested for specific alleles based on CPIC guidelines
Pre-test genetic counseling required: Help
No
Post-test genetic counseling required: Help
No
Conditions Help
Total conditions: 5
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 14
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 1
Method Category Help
Test method Help
Instrument
Targeted variant analysis
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Other
Clinical Information
Test purpose: Help
Drug Response
Clinical utility: Help
Guidance for selecting a drug therapy and/or dose
View citations (1)

Target population: Help
Individuals with a need for preemptive or reactive pharmacogenetic testing for drugs including statins, psychotropic and pain medications, and others
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS? Help
We do not report VUS for PGX.

Are family members with defined clinical status recruited to assess significance of VUS without charge? Help
No.

Will the lab re-contact the ordering physician if variant interpretation changes? Help
Not provided.
Recommended fields not provided:
Clinical validity, 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 Procedure: Help
Targeted next-generation sequencing (tNGS) is performed for the genes listed above. Data is processed and analyzed using the Sanford GeneART pipeline. When CYP2D6 is reported, copy number variants are assessed by droplet digital PCR (ddPCR) using CYP2D6-specific probes for intron 2 and exon 9. When the copy number call is … View more
Test Platform:
Other
Test Confirmation: Help
Unexplained or unexpected results are confirmed by Sanger sequencing, Quantstudio or ddPCR.
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
Variant-level accuracy: 99.8%. Variant-level sensitivity: 0.994. Variant-level specificity: 0.999.
View citations (39)
  • , Link E, Parish S, Armitage J, Bowman L, Heath S, Matsuda F, Gut I, Lathrop M, Collins R. SLCO1B1 variants and statin-induced myopathy--a genomewide study. N Engl J Med. 2008;359(8):789-99. doi:10.1056/NEJMoa0801936. Epub 2008 Jul 23. PMID: 18650507.
  • Mega JL, Close SL, Wiviott SD, Shen L, Hockett RD, Brandt JT, Walker JR, Antman EM, Macias W, Braunwald E, Sabatine MS. Cytochrome p-450 polymorphisms and response to clopidogrel. N Engl J Med. 2009;360(4):354-62. doi:10.1056/NEJMoa0809171. Epub 2008 Dec 22. PMID: 19106084.
  • The SLCO1B1*5 genetic variant is associated with statin-induced side effects. Voora D, et al. J Am Coll Cardiol. 2009;54(17):1609-16. doi:10.1016/j.jacc.2009.04.053. PMID: 19833260.
  • The sequenced treatment alternatives to relieve depression (STAR*D) trial: a review. Sinyor M, et al. Can J Psychiatry. 2010;55(3):126-35. doi:10.1177/070674371005500303. PMID: 20370962.
  • 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.
  • Muir AJ, Gong L, Johnson SG, Lee MT, Williams MS, Klein TE, Caudle KE, Nelson DR, . Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines for IFNL3 (IL28B) genotype and PEG interferon-α-based regimens. Clin Pharmacol Ther. 2014;95(2):141-6. doi:10.1038/clpt.2013.203. Epub 2013 Oct 04. PMID: 24096968.
  • Kimmel SE, French B, Kasner SE, Johnson JA, Anderson JL, Gage BF, Rosenberg YD, Eby CS, Madigan RA, McBane RB, Abdel-Rahman SZ, Stevens SM, Yale S, Mohler ER, Fang MC, Shah V, Horenstein RB, Limdi NA, Muldowney JA, Gujral J, Delafontaine P, Desnick RJ, Ortel TL, Billett HH, Pendleton RC, Geller NL, Halperin JL, Goldhaber SZ, Caldwell MD, Califf RM, Ellenberg JH, . A pharmacogenetic versus a clinical algorithm for warfarin dosing. N Engl J Med. 2013;369(24):2283-93. doi:10.1056/NEJMoa1310669. Epub 2013 Nov 19. PMID: 24251361.
  • Ramsey LB, Johnson SG, Caudle KE, Haidar CE, Voora D, Wilke RA, Maxwell WD, McLeod HL, Krauss RM, Roden DM, Feng Q, Cooper-DeHoff RM, Gong L, Klein TE, Wadelius M, Niemi M. The clinical pharmacogenetics implementation consortium guideline for SLCO1B1 and simvastatin-induced myopathy: 2014 update. Clin Pharmacol Ther. 2014;96(4):423-8. doi:10.1038/clpt.2014.125. Epub 2014 Jun 11. PMID: 24918167.
  • Birdwell KA, Decker B, Barbarino JM, Peterson JF, Stein CM, Sadee W, Wang D, Vinks AA, He Y, Swen JJ, Leeder JS, van Schaik R, Thummel KE, Klein TE, Caudle KE, MacPhee IA. Clinical Pharmacogenetics Implementation Consortium (CPIC) Guidelines for CYP3A5 Genotype and Tacrolimus Dosing. Clin Pharmacol Ther. 2015;98(1):19-24. doi:10.1002/cpt.113. Epub 2015 Jun 03. PMID: 25801146.
  • 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.
  • Bell GC, Caudle KE, Whirl-Carrillo M, Gordon RJ, Hikino K, Prows CA, Gaedigk A, Agundez J, Sadhasivam S, Klein TE, Schwab M. Clinical Pharmacogenetics Implementation Consortium (CPIC) guideline for CYP2D6 genotype and use of ondansetron and tropisetron. Clin Pharmacol Ther. 2017;102(2):213-218. doi:10.1002/cpt.598. Epub 2017 Apr 06. PMID: 28002639.
  • Johnson JA, Caudle KE, Gong L, Whirl-Carrillo M, Stein CM, Scott SA, Lee MT, Gage BF, Kimmel SE, Perera MA, Anderson JL, Pirmohamed M, Klein TE, Limdi NA, Cavallari LH, Wadelius M. Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for Pharmacogenetics-Guided Warfarin Dosing: 2017 Update. Clin Pharmacol Ther. 2017;102(3):397-404. doi:10.1002/cpt.668. Epub 2017 Apr 04. PMID: 28198005.
  • Pérez V, Salavert A, Espadaler J, Tuson M, Saiz-Ruiz J, Sáez-Navarro C, Bobes J, Baca-García E, Vieta E, Olivares JM, Rodriguez-Jimenez R, Villagrán JM, Gascón J, Cañete-Crespillo J, Solé M, Saiz PA, Ibáñez Á, de Diego-Adeliño J, , Menchón JM. Efficacy of prospective pharmacogenetic testing in the treatment of major depressive disorder: results of a randomized, double-blind clinical trial. BMC Psychiatry. 2017;17(1):250. doi:10.1186/s12888-017-1412-1. Epub 2017 Jul 14. PMID: 28705252.
  • Effect of Genotype-Guided Warfarin Dosing on Clinical Events and Anticoagulation Control Among Patients Undergoing Hip or Knee Arthroplasty: The GIFT Randomized Clinical Trial. Gage BF, et al. JAMA. 2017;318(12):1115-1124. doi:10.1001/jama.2017.11469. PMID: 28973620.
  • Cavallari LH, Lee CR, Beitelshees AL, Cooper-DeHoff RM, Duarte JD, Voora D, Kimmel SE, McDonough CW, Gong Y, Dave CV, Pratt VM, Alestock TD, Anderson RD, Alsip J, Ardati AK, Brott BC, Brown L, Chumnumwat S, Clare-Salzler MJ, Coons JC, Denny JC, Dillon C, Elsey AR, Hamadeh IS, Harada S, Hillegass WB, Hines L, Horenstein RB, Howell LA, Jeng LJB, Kelemen MD, Lee YM, Magvanjav O, Montasser M, Nelson DR, Nutescu EA, Nwaba DC, Pakyz RE, Palmer K, Peterson JF, Pollin TI, Quinn AH, Robinson SW, Schub J, Skaar TC, Smith DM, Sriramoju VB, Starostik P, Stys TP, Stevenson JM, Varunok N, Vesely MR, Wake DT, Weck KE, Weitzel KW, Wilke RA, Willig J, Zhao RY, Kreutz RP, Stouffer GA, Empey PE, Limdi NA, Shuldiner AR, Winterstein AG, Johnson JA, . Multisite Investigation of Outcomes With Implementation of CYP2C19 Genotype-Guided Antiplatelet Therapy After Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2018;11(2):181-191. doi:10.1016/j.jcin.2017.07.022. Epub 2017 Nov 01. PMID: 29102571.
  • Amstutz U, Henricks LM, Offer SM, Barbarino J, Schellens JHM, Swen JJ, Klein TE, McLeod HL, Caudle KE, Diasio RB, Schwab M. Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for Dihydropyrimidine Dehydrogenase Genotype and Fluoropyrimidine Dosing: 2017 Update. Clin Pharmacol Ther. 2018;103(2):210-216. doi:10.1002/cpt.911. Epub 2017 Nov 20. PMID: 29152729.
  • Goetz MP, Sangkuhl K, Guchelaar HJ, Schwab M, Province M, Whirl-Carrillo M, Symmans WF, McLeod HL, Ratain MJ, Zembutsu H, Gaedigk A, van Schaik RH, Ingle JN, Caudle KE, Klein TE. Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for CYP2D6 and Tamoxifen Therapy. Clin Pharmacol Ther. 2018;103(5):770-777. doi:10.1002/cpt.1007. Epub 2018 Jan 31. PMID: 29385237.
  • Pratt VM, Del Tredici AL, Hachad H, Ji Y, Kalman LV, Scott SA, Weck KE. Recommendations for Clinical CYP2C19 Genotyping Allele Selection: A Report of the Association for Molecular Pathology. J Mol Diagn. 2018;20(3):269-276. doi:10.1016/j.jmoldx.2018.01.011. Epub 2018 Feb 21. PMID: 29474986.
  • Relling MV, Schwab M, Whirl-Carrillo M, Suarez-Kurtz G, Pui CH, Stein CM, Moyer AM, Evans WE, Klein TE, Antillon-Klussmann FG, Caudle KE, Kato M, Yeoh AEJ, Schmiegelow K, Yang JJ. Clinical Pharmacogenetics Implementation Consortium Guideline for Thiopurine Dosing Based on TPMT and NUDT15 Genotypes: 2018 Update. Clin Pharmacol Ther. 2019;105(5):1095-1105. doi:10.1002/cpt.1304. Epub 2019 Jan 20. PMID: 30447069.
  • Gonsalves SG, Dirksen RT, Sangkuhl K, Pulk R, Alvarellos M, Vo T, Hikino K, Roden D, Klein TE, Poler SM, Patel S, Caudle KE, Gordon R, Brandom B, Biesecker LG. Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for the Use of Potent Volatile Anesthetic Agents and Succinylcholine in the Context of RYR1 or CACNA1S Genotypes. Clin Pharmacol Ther. 2019;105(6):1338-1344. doi:10.1002/cpt.1319. Epub 2019 Jan 24. PMID: 30499100.
  • Smith DM, Weitzel KW, Elsey AR, Langaee T, Gong Y, Wake DT, Duong BQ, Hagen M, Harle CA, Mercado E, Nagoshi Y, Newsom K, Wright A, Rosenberg EI, Starostik P, Clare-Salzler MJ, Schmidt SO, Fillingim RB, Johnson JA, Cavallari LH. CYP2D6-guided opioid therapy improves pain control in CYP2D6 intermediate and poor metabolizers: a pragmatic clinical trial. Genet Med. 2019;21(8):1842-1850. doi:10.1038/s41436-018-0431-8. Epub 2019 Jan 23. PMID: 30670877.
  • Greden JF, Parikh SV, Rothschild AJ, Thase ME, Dunlop BW, DeBattista C, Conway CR, Forester BP, Mondimore FM, Shelton RC, Macaluso M, Li J, Brown K, Gilbert A, Burns L, Jablonski MR, Dechairo B. Impact of pharmacogenomics on clinical outcomes in major depressive disorder in the GUIDED trial: A large, patient- and rater-blinded, randomized, controlled study. J Psychiatr Res. 2019;111:59-67. doi:10.1016/j.jpsychires.2019.01.003. Epub 2019 Jan 04. PMID: 30677646.
  • Brown JT, Bishop JR, Sangkuhl K, Nurmi EL, Mueller DJ, Dinh JC, Gaedigk A, Klein TE, Caudle KE, McCracken JT, de Leon J, Leeder JS. Clinical Pharmacogenetics Implementation Consortium Guideline for Cytochrome P450 (CYP)2D6 Genotype and Atomoxetine Therapy. Clin Pharmacol Ther. 2019;106(1):94-102. doi:10.1002/cpt.1409. Epub 2019 Apr 13. PMID: 30801677.
  • Petry N, Lupu R, Gohar A, Larson EA, Peterson C, Williams V, Zhao J, Wilke RA, Hines LJ. genotype, physician prescribing pattern, and risk for long QT on serotonin selective reuptake inhibitors. Pharmacogenomics. 2019;20(5):343-351. doi:10.2217/pgs-2018-0156. Epub 2019 Apr 15. PMID: 30983508.
  • Pratt VM, Cavallari LH, Del Tredici AL, Hachad H, Ji Y, Moyer AM, Scott SA, Whirl-Carrillo M, Weck KE. Recommendations for Clinical CYP2C9 Genotyping Allele Selection: A Joint Recommendation of the Association for Molecular Pathology and College of American Pathologists. J Mol Diagn. 2019;21(5):746-755. doi:10.1016/j.jmoldx.2019.04.003. Epub 2019 May 08. PMID: 31075510.
  • Claassens DMF, Vos GJA, Bergmeijer TO, Hermanides RS, van 't Hof AWJ, van der Harst P, Barbato E, Morisco C, Tjon Joe Gin RM, Asselbergs FW, Mosterd A, Herrman JR, Dewilde WJM, Janssen PWA, Kelder JC, Postma MJ, de Boer A, Boersma C, Deneer VHM, Ten Berg JM. A Genotype-Guided Strategy for Oral P2Y. N Engl J Med. 2019;381(17):1621-1631. doi:10.1056/NEJMoa1907096. Epub 2019 Sep 03. PMID: 31479209.
  • Theken KN, Lee CR, Gong L, Caudle KE, Formea CM, Gaedigk A, Klein TE, Agúndez JAG, Grosser T. Clinical Pharmacogenetics Implementation Consortium Guideline (CPIC) for CYP2C9 and Nonsteroidal Anti-Inflammatory Drugs. Clin Pharmacol Ther. 2020;108(2):191-200. doi:10.1002/cpt.1830. Epub 2020 Apr 28. PMID: 32189324.
  • Pratt VM, Cavallari LH, Del Tredici AL, Hachad H, Ji Y, Kalman LV, Ly RC, Moyer AM, Scott SA, Whirl-Carrillo M, Weck KE. Recommendations for Clinical Warfarin Genotyping Allele Selection: A Report of the Association for Molecular Pathology and the College of American Pathologists. J Mol Diagn. 2020;22(7):847-859. doi:10.1016/j.jmoldx.2020.04.204. Epub 2020 May 04. PMID: 32380173.
  • Using pharmacogenetics to structure individual pain management protocols in total knee arthroplasty. Hamilton WG, et al. Bone Joint J. 2020;102-B(6_Supple_A):73-78. doi:10.1302/0301-620X.102B6.BJJ-2019-1539.R1. PMID: 32475277.
  • 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.
  • Karnes JH, Rettie AE, Somogyi AA, Huddart R, Fohner AE, Formea CM, Ta Michael Lee M, Llerena A, Whirl-Carrillo M, Klein TE, Phillips EJ, Mintzer S, Gaedigk A, Caudle KE, Callaghan JT. Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for CYP2C9 and HLA-B Genotypes and Phenytoin Dosing: 2020 Update. Clin Pharmacol Ther. 2021;109(2):302-309. doi:10.1002/cpt.2008. Epub 2020 Sep 06. PMID: 32779747.
  • Effect of Genotype-Guided Oral P2Y12 Inhibitor Selection vs Conventional Clopidogrel Therapy on Ischemic Outcomes After Percutaneous Coronary Intervention: The TAILOR-PCI Randomized Clinical Trial. Pereira NL, et al. JAMA. 2020;324(8):761-771. doi:10.1001/jama.2020.12443. PMID: 32840598.
  • Crews KR, Monte AA, Huddart R, Caudle KE, Kharasch ED, Gaedigk A, Dunnenberger HM, Leeder JS, Callaghan JT, Samer CF, Klein TE, Haidar CE, Van Driest SL, Ruano G, Sangkuhl K, Cavallari LH, Müller DJ, Prows CA, Nagy M, Somogyi AA, Skaar TC. Clinical Pharmacogenetics Implementation Consortium Guideline for CYP2D6, OPRM1, and COMT Genotypes and Select Opioid Therapy. Clin Pharmacol Ther. 2021;110(4):888-896. doi:10.1002/cpt.2149. Epub 2021 Feb 09. PMID: 33387367.
  • Lu B, Sun L, Seraydarian M, Hoffmann TJ, Medina MW, Risch N, Iribarren C, Krauss RM, Oni-Orisan A. Effect of SLCO1B1 T521C on Statin-Related Myotoxicity With Use of Lovastatin and Atorvastatin. Clin Pharmacol Ther. 2021;110(3):733-740. doi:10.1002/cpt.2337. Epub 2021 Jul 23. PMID: 34114646.
  • Pratt VM, Cavallari LH, Del Tredici AL, Gaedigk A, Hachad H, Ji Y, Kalman LV, Ly RC, Moyer AM, Scott SA, van Schaik RHN, Whirl-Carrillo M, Weck KE. Recommendations for Clinical CYP2D6 Genotyping Allele Selection: A Joint Consensus Recommendation of the Association for Molecular Pathology, College of American Pathologists, Dutch Pharmacogenetics Working Group of the Royal Dutch Pharmacists Association, and the European Society for Pharmacogenomics and Personalized Therapy. J Mol Diagn. 2021;23(9):1047-1064. doi:10.1016/j.jmoldx.2021.05.013. Epub 2021 Jun 10. PMID: 34118403.
  • Antidepressant drugs affect dopamine uptake. Halaris AE, et al. Biochem Pharmacol. 1975;24(20):1896-7. doi:10.1016/0006-2952(75)90412-8. PMID: 19. Table of Pharmacogenomic Associations. U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/precision-medicine/table-pharmacogenetic-associations. Accessed August 10, 2021..
  • https://www.fda.gov/medical-devices/precision-medicine/table-pharmacogenetic-associations
Assay limitations: Help
This analysis does not detect all variants with known impact on enzyme expression and activities. Non-genetic factors, variations in the other genes involving drug metabolism, or drug-drug interactions are not measured by this assay. The minimum depth of coverage is 16 reads. Phasing for alleles is not performed. the diplotype … 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
College of American Pathologists, CAP

CAP Testing Information Help
Pharmacogenetics; CYP2C19; PGX
Pharmacogenetics; CYP2C9; PGX
Pharmacogenetics; CYP2D6; PGX
Pharmacogenetics; CYP3A4; PGX
Pharmacogenetics; CYP3A5; PGX
Pharmacogenetics; CYP4F2; PGX
Pharmacogenetics; SLCO1B1; PGX
Pharmacogenetics; VKORC1; PGX
VUS:
Laboratory's policy on reporting novel variations Help
We do not do WES/WGS, therefore we don't report or screen for novel variants
Recommended fields not provided:
Citations to support assay limitations, Description of internal test validation method, Description of PT method
Regulatory Approval
FDA Review: Help
Category: FDA exercises enforcement discretion
Additional Information
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.