Clinical Genetic Test
offered by
GTR Test Accession:
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GTR000508104.7
CAP
Last updated in GTR:
2024-06-21
View version history
GTR000508104.7,
last updated:
2024-06-21
GTR000508104.6,
last updated:
2023-06-27
GTR000508104.5,
last updated:
2022-07-12
GTR000508104.4,
last updated:
2021-07-13
GTR000508104.3,
last updated:
2020-07-15
GTR000508104.2,
last updated:
2019-07-26
GTR000508104.1,
registered in GTR:
2018-07-25
Last annual review date for the lab: 2024-06-28
LinkOut
At a Glance
Test purpose:
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Drug Response
Conditions (1):
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Disorder due cytochrome p450 CYP2D6 variant
Genes (1):
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CYP2D6 (22q13.2)
Methods (1):
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Molecular Genetics - Targeted variant analysis: SNP Detection
Target population: Help
Not provided
Clinical validity:
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Not provided
Clinical utility:
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Not provided
Ordering Information
Offered by:
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Test short name:
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2D6
Specimen Source:
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- Peripheral (whole) blood
- View specimen requirements
Test Order Code:
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10490
View other test codes
View other test codes
CPT codes:
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Contact Policy:
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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:
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5 ml whole blood EDTA preferred
Also acceptable EDTA (royal blue), ACD-A or ACD-B (yellow-top), Sodium heparin (green-top)
Order URL
Also acceptable EDTA (royal blue), ACD-A or ACD-B (yellow-top), Sodium heparin (green-top)
Order URL
Test development:
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Test developed by laboratory (no manufacturer test name)
Informed consent required:
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Based on applicable state law
Pre-test genetic counseling required:
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No
Post-test genetic counseling required:
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No
Recommended fields not provided:
Lab contact for this test,
Test strategy
Conditions
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Total conditions: 1
Condition/Phenotype | Identifier |
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Test Targets
Genes
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Total genes: 1
Gene | Associated Condition | Germline or Somatic | Allele (Lab-provided) | Variant in NCBI |
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Methodology
Total methods: 1
Method Category
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Test method
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Instrument *
Targeted variant analysis
SNP Detection
* Instrument: Not provided
Clinical Information
Test purpose:
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Drug Response
Variant Interpretation:
Are family members with defined clinical status recruited to assess significance of VUS without charge?
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No.
No.
Will the lab re-contact the ordering physician if variant interpretation changes?
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Not provided.
Not provided.
Recommended fields not provided:
Clinical validity,
Clinical utility,
Target population,
What is the protocol for interpreting a variation as a VUS?,
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:
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Tests performed
Entire test performed in-house
Entire test performed in-house
Analytical Validity:
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Analytical sensitivity and specificity = 99%
Proficiency testing (PT):
Is proficiency testing performed for this test?
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Yes
Method used for proficiency testing: Help
Formal PT program
PT Provider: Help
American College of Medical Genetics / College of American Pathologists, ACMG/CAP
Yes
Method used for proficiency testing: Help
Formal PT program
PT Provider: Help
American College of Medical Genetics / College of American Pathologists, ACMG/CAP
Recommended fields not provided:
Test Confirmation,
Assay limitations,
Description of internal test validation method,
Citations for Analytical validity,
Description of PT method,
Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review:
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Category:
FDA exercises enforcement discretion
Additional Information
Reviews:
Clinical resources:
Molecular resources:
Practice guidelines:
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.