GTR Test Accession:
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GTR000604047.1
CAP
Registered in GTR:
2023-01-24
View version history
GTR000604047.1,
registered in GTR:
2023-01-24
Last annual review date for the lab: 2023-12-07
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At a Glance
Test purpose:
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Drug Response
Conditions (59):
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Selective serotonin reuptake inhibitor response;
Alprazolam response;
Amitriptyline response
more...
Genes (8):
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Methods (2):
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Molecular Genetics - Deletion/duplication analysis: RT-qPCR; ...
Target population: Help
Individuals currently taking multiple prescription medications or who have previously …
Clinical validity:
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All drugs are metabolized to some extent in the human …
Clinical utility:
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Guidance for selecting a drug therapy and/or dose;
Guidance for selecting a drug therapy and/or dose;
Guidance for selecting a drug therapy and/or dose
Ordering Information
Offered by:
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Test short name:
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Psych
Specimen Source:
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- Buccal swab
Who can order: Help
- Health Care Provider
- Licensed Dentist
- Licensed Physician
- Nurse Practitioner
- Physician Assistant
Test Order Code:
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Psych-PGx
LOINC codes:
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Lab contact:
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Elaine Allgood, MD, ABPath, FCAP, Lab Director
elaine.allgood16@gmail.com
417-319-1047
Jacob Norton, MS, FCAP, Lab Manager
rhy@dynamicdnalabs.com
417-319-1047
elaine.allgood16@gmail.com
417-319-1047
Jacob Norton, MS, FCAP, Lab Manager
rhy@dynamicdnalabs.com
417-319-1047
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.
Pre-test email/phone consultation regarding genetic test results and interpretation is provided to patients/families.
Pre-test email/phone consultation regarding genetic test results and interpretation is provided to patients/families.
How to Order:
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Contact laboratory to receive requisition form. If this is the first time ordering, a new account setup form is also required. Kits for buccal cell collection are provided along with pre-paid and pre-labeled return mailers.
Order URL
Order URL
Test service:
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Clinical Testing/Confirmation of Mutations Identified Previously
Comment: Pharmacogenomic Testing
Comment: Pharmacogenomic Testing
Test development:
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Test developed by laboratory (no manufacturer test name)
Informed consent required:
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Yes
Test strategy:
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Order test before prescribing high risk medication. Only final reports are issued.
Pre-test genetic counseling required:
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No
Post-test genetic counseling required:
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No
Conditions
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Total conditions: 59
Condition/Phenotype | Identifier |
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Test Targets
Genes
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Total genes: 8
Gene | Associated Condition | Germline or Somatic | Allele (Lab-provided) | Variant in NCBI |
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Methodology
Total methods: 2
Method Category
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Test method
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Instrument
Deletion/duplication analysis
RT-qPCR
ABI QuantStudio 12K Flex
Targeted variant analysis
Microarray
Illumina iScan
Clinical Information
Test purpose:
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Drug Response
Clinical validity:
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All drugs are metabolized to some extent in the human body. Nearly all of the enzymes and transporters involved in drug metabolism are known to contain genetic polymorphisms across the human population. Some of these polymorphisms are known to contribute to altered function and subsequent altered drug metabolism. Therefore, determination …
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View citations (2)
- DOI: 10.1186/gm499
- doi: 10.31887/DCNS.2016.18.3/jbishop
Clinical utility:
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Guidance for selecting a drug therapy and/or dose
Guidance for selecting a drug therapy and/or dose
Guidance for selecting a drug therapy and/or dose
View citations (1)
- DOI: 10.1016/j.mayocp.2017.09.001
Guidance for selecting a drug therapy and/or dose
View citations (1)
- doi: 10.2174/1389200215666140130124910
Guidance for selecting a drug therapy and/or dose
Target population:
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Individuals currently taking multiple prescription medications or who have previously had an adverse drug event (ADE).
View citations (1)
- DOI: 10.1371/journal.pone.0164972
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS?
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VUS are not identified in this testing.
VUS are not identified in this testing.
Will the lab re-contact the ordering physician if variant interpretation changes?
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Not provided. Laboratory will need to be recontacted for new interpretations.
Not provided. Laboratory will need to be recontacted for new interpretations.
Sample reports:
Recommended fields not provided:
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 positive report
Technical Information
Test Procedure:
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Buccal swabs are used as the specimen type. Genomic DNA is extracted from buccal swabs using an ABI magnetic particle processor (MagMAX). Purified DNA is then quantified using qPCR. Microarray analysis is then performed using the Illumina Global Screening Array v3 (w/DTC booster) beadchip and the Illumina iScan. CYP2D6 copy …
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Test Platform:
None/not applicable
Availability:
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Tests performed
Entire test performed in-house
Test performance comments
Reports are generated at the laboratory, by laboratory staff, but are produced using an API owned and operated by Coriell Life Sciences.
Entire test performed in-house
Test performance comments
Reports are generated at the laboratory, by laboratory staff, but are produced using an API owned and operated by Coriell Life Sciences.
Analytical Validity:
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The minimum concentration of this assay was validated using 384 samples and was determine to be between 2.5 ng/uL and 50 ng/uL. Qualitative reproducibility was determined to be 99.90% percent using a total of 12 samples and over 7.9 million genotypes in total. Qualitative accuracy was determined by testing 382 …
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View citations (1)
- DOI: 10.1002/mgg3.2016
Assay limitations:
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Extracted samples with a DNA concentration below 2.5 ng/uL are unable to be tested. Additionally, this assay does not detect genetic variants other than those listed on the report.
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
College of American Pathologists, CAP
Description of PT method: Help
Formal PT is performed using the APOE, MGL1, and PGX products available from the College of American Pathologists. Each program consists of two sets of challenges per year, with each challenge consisting of three samples. Assays that are not covered in a formal PT program are subject to an in-house … View more
Description of internal test validation method: Help
Prior to patient testing an internal validation was designed using the parameters set forth by the College of American Pathologists (CAP). This validation meets or exceeds all defined parameters. Additional validations are performed per processing cycle that consists of negative (no template controls) and positive (samples of known genotypes) reactivity.
Yes
Method used for proficiency testing: Help
Formal PT program
PT Provider: Help
College of American Pathologists, CAP
Description of PT method: Help
Formal PT is performed using the APOE, MGL1, and PGX products available from the College of American Pathologists. Each program consists of two sets of challenges per year, with each challenge consisting of three samples. Assays that are not covered in a formal PT program are subject to an in-house … View more
Description of internal test validation method: Help
Prior to patient testing an internal validation was designed using the parameters set forth by the College of American Pathologists (CAP). This validation meets or exceeds all defined parameters. Additional validations are performed per processing cycle that consists of negative (no template controls) and positive (samples of known genotypes) reactivity.
VUS:
Software used to interpret novel variations
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Coriell Life Sciences API
Laboratory's policy on reporting novel variations Help
Novel variants are not identified in this testing.
Coriell Life Sciences API
Laboratory's policy on reporting novel variations Help
Novel variants are not identified in this testing.
Recommended fields not provided:
Test Confirmation,
Citations to support assay limitations,
Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review:
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Category:
Not Applicable
Additional Information
Reviews:
Clinical resources:
Molecular resources:
Consumer resources:
IMPORTANT NOTE:
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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.