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Cytochrome P450 2D6 Genotyping
Clinical Genetic Test
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offered by
Monogram Biosciences
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GTR Test Accession: Help GTR000576380.1
INHERITED DISEASEPHARMACOGENOMIC
Registered in GTR: 2020-05-06
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Last annual review date for the lab: 2022-04-25 Past due LinkOut
At a Glance
Test purpose: Help
Drug Response
Conditions (1): Help
Disorder due cytochrome p450 CYP2D6 variant
Genes (1): Help
CYP2D6 (22q13.2)
Methods (2): Help
Molecular Genetics - Targeted variant analysis: Allele-specific primer extension (ASPE); PCR
Target population: Help
Not provided
Clinical validity: Help
Not provided
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
Monogram Biosciences
View lab's website
View lab's test page
Test Order Code: Help
511230
How to Order: Help
Order URL
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:
Specimen source, 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: 1
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 2
Method Category Help
Test method Help
Instrument *
Targeted variant analysis
Allele-specific primer extension (ASPE)
Targeted variant analysis
PCR
* Instrument: Not provided
Clinical Information
Test purpose: Help
Drug Response
Recommended fields not provided:
Clinical validity, Clinical utility, 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
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
Reproducibility: 100% Accuracy: 100% (compared to sequencing) Limit of Detection: 4 ng/μL Interfering Substances: no interference by hemoglobin, bilirubin, albumin, and triglycerides at concentrations tested
View citations (1)
  • xTAG® CYP2D6 Kit v3 US-IVD [package insert]. Luminex; MLD-030-KPI-001 Rev G; 2018.
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
No
Recommended fields not provided:
Test Confirmation, Assay limitations, Description of internal test validation method, PT Provider, Description of PT method, Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review: Help
Not provided
Additional Information

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