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PGx - Gastrointestinal Panel
Clinical Genetic Test
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offered by
Genesys Diagnostics
View lab's test page
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GTR Test Accession: Help GTR000607967.1
CAP
PHARMACOGENOMIC
Registered in GTR: 2023-08-15
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Last annual review date for the lab: 2024-07-05 LinkOut
At a Glance
Test purpose: Help
Drug Response
Conditions (1): Help
Drug metabolism or response
Genes (5): Help
ABCB1 (7q21.12); CYP2C19 (10q23.33); CYP2C9 (10q23.33); CYP2D6 (22q13.2); CYP3A4 (7q22.1)
Methods (1): Help
Molecular Genetics - Targeted variant analysis: PCR with allele specific hybridization
Target population: Help
Patients who are suspected of non-standard medication metabolism or response, …
Clinical validity: Help
Not provided
Clinical utility: Help
Guidance for selecting a drug therapy and/or dose
Ordering Information
Offered by: Help
Genesys Diagnostics
View lab's website
View lab's test page
Specimen Source: Help
  • Buccal swab
  • Peripheral (whole) blood
Who can order: Help
  • Health Care Provider
  • Nurse Practitioner
Test Order Code: Help
GP
Informed consent required: Help
Yes
Pre-test genetic counseling required: Help
Decline to answer
Post-test genetic counseling required: Help
Decline to answer
Recommended fields not provided:
How to Order, Lab contact for this test, Contact policy, Test strategy, Test development
Conditions Help
Total conditions: 1
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 5
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
PCR with allele specific hybridization
* Instrument: Not provided
Clinical Information
Test purpose: Help
Drug Response
Clinical utility: Help
Guidance for selecting a drug therapy and/or dose
View citations (1)
  • Pharmacogenetic testing: Current Evidence of Clinical Utility. Moaddeb J, et al. Ther Adv Drug Saf. 2013;4(4):155-169. doi:10.1177/2042098613485595. PMID: 24020014.

Target population: Help
Patients who are suspected of non-standard medication metabolism or response, are suspected of being at risk of adverse drug reactions, have a personal or family history of adverse drug reactions, or have a family member with a known variant of pharmacogenomic significance.
View citations (1)
  • Hiratsuka M, Zhou Y, Lauschke VM. Editorial: Population Pharmacogenomics (PGx): From Variant Identification to Clinical Implementation. Front Genet. 2021;12:736626. doi:10.3389/fgene.2021.736626. Epub 2021 Aug 05. PMID: 34422026.
Recommended fields not provided:
Clinical validity, 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
The GDI Gastrointestinal Pharmacogenomics Panel genotypes 5 genes using multiplex PCR and MALDI-TOF Mass Spectrometry. This pharmacogenomics panel was validated by Genesys Diagnostics and has has 100% Sensitivity and 100% Specificity.
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 (legacy) Help
Pharmacogenetics; CYP2C19; PGX
Pharmacogenetics; CYP2C9; PGX
Pharmacogenetics; CYP2D6; PGX
Pharmacogenetics; CYP3A4; PGX
Recommended fields not provided:
Test Confirmation, Assay limitations, Description of internal test validation method, Citations for Analytical validity, Description of PT method
Regulatory Approval
FDA Review: Help
Not provided
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.