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Polypharmacy Comprehensive Panel
Clinical Genetic Test
Help
offered by
Labcorp Genetics (formerly Invitae)
View lab's test page
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GTR Test Accession: Help GTR000593013.1
NYS CLEP
CAP
PHARMACOGENOMICINHERITED DISEASE
Registered in GTR: 2021-05-06
View version history
Last annual review date for the lab: 2023-10-10 Past due LinkOut
At a Glance
Test purpose: Help
Drug Response; Risk Assessment; Screening; ...
Conditions (33): Help
Amitriptyline response; Aripiprazole response; Atomoxetine response more...
Genes (24): Help
ADRA2A (10q25.2); COMT (22q11.21); CYP1A2 (15q24.1); CYP2B6 (19q13.2); CYP2C19 (10q23.33) more...
Methods (2): Help
Molecular Genetics - Deletion/duplication analysis: PCR with allele specific hybridization; ...
Target population: Help
Comprehensive medication management based on the YouScript® clinical decision support …
Clinical validity: Help
Not provided
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
Labcorp Genetics (formerly Invitae)
View lab's website
View lab's test page
Specimen Source: Help
  • Isolated DNA
  • Peripheral (whole) blood
  • Saliva
Who can order: Help
  • Genetic Counselor
  • Health Care Provider
  • Licensed Physician
  • Nurse Practitioner
  • Physician Assistant
  • Registered Nurse
How to Order: Help
Tests can be ordered online or by submitting a paper requisition form.
Order URL
Test service: Help
Clinical Testing/Confirmation of Mutations Identified Previously
Custom Deletion/Duplication Testing
Result interpretation
Informed consent required: Help
Based on applicable state law
Pre-test genetic counseling required: Help
No
Post-test genetic counseling required: Help
No
Recommended fields not provided:
Test Order Code, Lab contact for this test, Contact policy, Test strategy, Test development
Conditions Help
Total conditions: 33
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 24
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 2
Method Category Help
Test method Help
Instrument
Deletion/duplication analysis
PCR with allele specific hybridization
Agena Mass Spectrometry
Targeted variant analysis
SNP Detection
Other
Clinical Information
Test purpose: Help
Drug Response; Risk Assessment; Screening; Therapeutic management
Target population: Help
Comprehensive medication management based on the YouScript® clinical decision support tool and DNA pharmacogenetic testing. Patient is taking, or planning to take, medicine(s) metabolized by the pharmacokinetic genes from the Cytochrome P450 family and other relevant pharmacodynamic genes that mediate the effects of commonly prescribed medications; or has a personal/family … View more
View citations (2)
  • Brixner D, Biltaji E, Bress A, Unni S, Ye X, Mamiya T, Ashcraft K, Biskupiak J. The effect of pharmacogenetic profiling with a clinical decision support tool on healthcare resource utilization and estimated costs in the elderly exposed to polypharmacy. J Med Econ. 2016;19(3):213-28. doi:10.3111/13696998.2015.1110160. Epub 2015 Nov 11. PMID: 26478982.
  • Elliott LS, Henderson JC, Neradilek MB, Moyer NA, Ashcraft KC, Thirumaran RK. Clinical impact of pharmacogenetic profiling with a clinical decision support tool in polypharmacy home health patients: A prospective pilot randomized controlled trial. PLoS One. 2017;12(2):e0170905. doi:10.1371/journal.pone.0170905. Epub 2017 Feb 02. PMID: 28151991.
Recommended fields not provided:
Clinical validity, Clinical utility, 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
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
Analytical sensitivity and specificity >99%. Analytical validity was assess for all genes using known Coriell cell line DNA and previously characterized donor samples. Studies included inter and intra assay precision, limit of detection, success rate, accuracy, interferences, sample stability, reagent stability, instrument and assay tolerances.
Assay limitations: Help
Genetic test results may be unclear or difficult to interpret due to current understanding of genetic disorder or condition and/or technical limitations of the test. Rare false negative or false positive results may occur. Predicted phenotype and allele functionality may change depending upon the emergence of new literature, industry standards … 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

Description of PT method: Help
Participation in formal program (CAP, MGL and PGX) as well as alternate proficiency programs testing all genes in panel per CLIA, CAP and NYSDOH guidelines.
Recommended fields not provided:
Test Confirmation, Citations to support assay limitations, Description of internal test validation method, Citations for Analytical validity, Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review: Help
Category: FDA exercises enforcement discretion
NYS CLEP Approval: Help
Number: 8201
Status: Approved
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.