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Psych HealthPGx Panel
Clinical Genetic Test
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offered by
RPRD Diagnostics, LLC
View lab's test page
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GTR Test Accession: Help GTR000597422.1
CAP
PHARMACOGENOMIC
Registered in GTR: 2022-03-17
View version history
Last annual review date for the lab: 2024-10-23 LinkOut
At a Glance
Test purpose: Help
Drug Response; Predictive; Risk Assessment; ...
Conditions (40): Help
Amitriptyline response; Atomoxetine response; Citalopram response more...
Genes (13): Help
ABCB1 (7q21.12); ANKK1 (11q23.2); COMT (22q11.21); CYP2C19 (10q23.33); CYP2D6 (22q13.2) more...
Methods (3): Help
Molecular Genetics - Deletion/duplication analysis: Microarray; ...
Target population: Help
Patients that are receiving or may receive medications where drug …
Clinical validity: Help
To determine the diagnostic sensitivity, we utilized the manufacturer’s recommended …
Clinical utility: Help
Guidance for selecting a drug therapy and/or dose; Pre-emptive clinical implementation
Ordering Information
Offered by: Help
RPRD Diagnostics, LLC
View lab's website
View lab's test page
Test short name: Help
Psych panel
Specimen Source: Help
Who can order: Help
  • Genetic Counselor
  • Health Care Provider
  • Licensed Physician
  • Physician Assistant
Test Order Code: Help
Psych HealthPGx Panel
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
Amy Turner, MS, Scientific Director
aturner@rprdx.com
(+1) 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
Acceptable specimen sources are 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 indicate sample source on test request form);
Saliva: Use DNA Genotek Oragene DNA (OG-500) kit. …
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Order URL
Test service: Help
Pharmacogenetics
Test development: Help
Test developed by laboratory (no manufacturer test name)
Informed consent required: Help
Decline to answer
Test strategy: Help
This test ideally is utilized pre-emptively (prior to receiving drug medication) or as a reflex testing when an adverse reaction to a medication has been observed.
View citations (5)
  • Shuldiner AR, Relling MV, Peterson JF, Hicks JK, Freimuth RR, Sadee W, Pereira NL, Roden DM, Johnson JA, Klein TE, , Shuldiner AR, Vesely M, Robinson SW, Ambulos N, Stass SA, Kelemen MD, Brown LA, Pollin TI, Beitelshees AL, Zhao RY, Pakyz RE, Palmer K, Alestock T, O'Neill C, Maloney K, Branham A, Sewell D, Relling MV, Crews K, Hoffman J, Cross S, Haidar C, Baker D, Hicks JK, Bell G, Greeson F, Gaur A, Reiss U, Huettel A, Cheng C, Gajjar A, Pappo A, Howard S, Hudson M, Pui CH, Jeha S, Evans WE, Broeckel U, Altman RB, Gong L, Whirl-Carrillo M, Klein TE, Sadee W, Manickam K, Sweet KM, Embi PJ, Roden D, Peterson J, Denny J, Schildcrout J, Bowton E, Pulley J, Beller M, Mitchell J, Danciu I, Price L, Pereira NL, Weinshilboum R, Wang L, Johnson JA, Nelson D, Clare-Salzler M, Elsey A, Burkley B, Langaee T, Liu F, Nessl D, Dong HJ, Lesko L, Freimuth RR, Chute CG. The Pharmacogenomics Research Network Translational Pharmacogenetics Program: overcoming challenges of real-world implementation. Clin Pharmacol Ther. 2013;94(2):207-10. doi:10.1038/clpt.2013.59. Epub 2013 Mar 19. PMID: 23588301.
  • Bell GC, Crews KR, Wilkinson MR, Haidar CE, Hicks JK, Baker DK, Kornegay NM, Yang W, Cross SJ, Howard SC, Freimuth RR, Evans WE, Broeckel U, Relling MV, Hoffman JM. Development and use of active clinical decision support for preemptive pharmacogenomics. J Am Med Inform Assoc. 2014;21(e1):e93-9. doi:10.1136/amiajnl-2013-001993. Epub 2013 Aug 26. PMID: 23978487.
  • Hoffman JM, Haidar CE, Wilkinson MR, Crews KR, Baker DK, Kornegay NM, Yang W, Pui CH, Reiss UM, Gaur AH, Howard SC, Evans WE, Broeckel U, Relling MV. PG4KDS: a model for the clinical implementation of pre-emptive pharmacogenetics. Am J Med Genet C Semin Med Genet. 2014;166C(1):45-55. doi:10.1002/ajmg.c.31391. Epub 2014 Mar 11. PMID: 24619595.
  • Dunnenberger HM, Crews KR, Hoffman JM, Caudle KE, Broeckel U, Howard SC, Hunkler RJ, Klein TE, Evans WE, Relling MV. Preemptive clinical pharmacogenetics implementation: current programs in five US medical centers. Annu Rev Pharmacol Toxicol. 2015;55:89-106. doi:10.1146/annurev-pharmtox-010814-124835. Epub 2014 Oct 02. PMID: 25292429.
  • Evidence and resources to implement pharmacogenetic knowledge for precision medicine. Caudle KE, et al. Am J Health Syst Pharm. 2016;73(23):1977-1985. doi:10.2146/ajhp150977. PMID: 27864205.
Pre-test genetic counseling required: Help
Decline to answer
Post-test genetic counseling required: Help
Decline to answer
Conditions Help
Total conditions: 40
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 13
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 3
Method Category Help
Test method Help
Instrument
Deletion/duplication analysis
Microarray
Affymetrix GeneTitan® MC
Targeted variant analysis
Microarray
Affymetrix GeneTitan® MC
Targeted variant analysis
PCR
Other
Clinical Information
Test purpose: Help
Drug Response; Predictive; Risk Assessment; Therapeutic management
Clinical validity: Help
To determine the diagnostic sensitivity, we utilized the manufacturer’s recommended input concentration and analysis QC thresholds. We demonstrated adherence to our validation threshold (i.e. ≥ 95% sensitivity) in detection of true positive results, with a false negative rate of ≤ 5%. To determine the diagnostic specificity, we utilized the manufacturer’s … View more
View citations (2)
Clinical utility: Help
Guidance for selecting a drug therapy and/or dose
View citations (4)
  • Hicks JK, Crews KR, Hoffman JM, Kornegay NM, Wilkinson MR, Lorier R, Stoddard A, Yang W, Smith C, Fernandez CA, Cross SJ, Haidar C, Baker DK, Howard SC, Evans WE, Broeckel U, Relling MV. A clinician-driven automated system for integration of pharmacogenetic interpretations into an electronic medical record. Clin Pharmacol Ther. 2012;92(5):563-6. doi:10.1038/clpt.2012.140. Epub 2012 Sep 19. PMID: 22990750.
  • Bell GC, Crews KR, Wilkinson MR, Haidar CE, Hicks JK, Baker DK, Kornegay NM, Yang W, Cross SJ, Howard SC, Freimuth RR, Evans WE, Broeckel U, Relling MV, Hoffman JM. Development and use of active clinical decision support for preemptive pharmacogenomics. J Am Med Inform Assoc. 2014;21(e1):e93-9. doi:10.1136/amiajnl-2013-001993. Epub 2013 Aug 26. PMID: 23978487.
  • 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.
  • 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.

Pre-emptive clinical implementation
View citations (1)
  • Hoffman JM, Haidar CE, Wilkinson MR, Crews KR, Baker DK, Kornegay NM, Yang W, Pui CH, Reiss UM, Gaur AH, Howard SC, Evans WE, Broeckel U, Relling MV. PG4KDS: a model for the clinical implementation of pre-emptive pharmacogenetics. Am J Med Genet C Semin Med Genet. 2014;166C(1):45-55. doi:10.1002/ajmg.c.31391. Epub 2014 Mar 11. PMID: 24619595.

Target population: Help
Patients that are receiving or may receive medications where drug metabolism is affected by variants detected by this panel.
View citations (3)
  • Gaedigk A, Sangkuhl K, Whirl-Carrillo M, Klein T, Leeder JS. Prediction of CYP2D6 phenotype from genotype across world populations. Genet Med. 2017;19(1):69-76. doi:10.1038/gim.2016.80. Epub 2016 Jul 07. PMID: 27388693.
  • CPIC® Guideline for Proton Pump Inhibitors and CYP2C19. https://cpicpgx.org/guidelines/cpic-guideline-for-proton-pump-inhibitors-and-cyp2c19/
  • CPIC® Guideline for Selective Serotonin Reuptake Inhibitors and CYP2D6 and CYP2C19 https://cpicpgx.org/guidelines/guideline-for-selective-serotonin-reuptake-inhibitors-and-cyp2d6-and-cyp2c19/
Variant Interpretation:
Are family members with defined clinical status recruited to assess significance of VUS without charge? Help
Decline to answer.

Will the lab re-contact the ordering physician if variant interpretation changes? Help
Decline to answer.
Recommended fields not provided:
What is the protocol for interpreting a variation as a VUS?, Is research allowed on the sample after clinical testing is complete?, Sample negative report, Sample positive report
Technical Information
Test Procedure: Help
PharmacoScanTM Assay 24-Array Format. Manual Protocol UserGuide. P/N 703286 Rev. 2. 2016. Affymetrix Inc
Test Platform:
Affymetrix Gene Profiling Array cGMP U133 P2
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
The analytical sensitivity (i.e. ability to detect analytes) of the assay was established utilizing the manufacturer’s established recommendation of a starting concentration of 5ng/uL of gDNA. All samples with that input concentration that pass the established assay QC metrics are considered “passing”. Any sample with this initial input concentration that … View more
View citations (4)
Assay limitations: Help
The assay tests for genetic variants at the specific loci listed in the PhamarcoScanTM annotation. Other variants that are not included in the assay may be present in the patient. The presence of additional variants may affect the accuracy of the detection of the variants reported. Analytical specificity and sensitivity … View more
View citations (2)
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

Description of PT method: Help
Testing is performed via a formal program with the College of American Pathologists (PGX program). PGX Genes Tested: Results: All genes with graded scores are passing (Good); all genes/components with ungraded scores/educational challenges, results are in concordance with the majority responses returned from all laboratories.
Recommended fields not provided:
Test Confirmation, Description of internal test validation method, Major CAP category, CAP category, CAP test list
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.