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iDNA PGx-CNS
Clinical Genetic Test
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iDNA Genomics
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GTR Test Accession: Help GTR000596379.1
PHARMACOGENOMICINHERITED DISEASE
Last updated in GTR: 2021-11-09
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Last annual review date for the lab: 2023-10-15 LinkOut
At a Glance
Test purpose: Help
Drug Response; Predictive; Therapeutic management
Conditions (30): Help
Aripiprazole response; Amisulpride response; Amitriptyline response; ...
Genes (12): Help
CYP2C19 (10q23.33), CYP2C9 (10q23.33), CYP2D6 (22q13.2), DRD2 (11q23.2), DRD3 (3q13.31), ...
Methods (1): Help
Molecular Genetics - Targeted variant analysis: PCR with allele specific hybridization
Target population: Help
Patients of diseases of the central nervous system.
Clinical validity: Help
Not provided
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
iDNA Genomics
View lab's test page
Test short name: Help
CNS
Specimen Source: Help
Who can order: Help
  • Genetic Counselor
  • Health Care Provider
  • Licensed Physician
Contact Policy: Help
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: Help
Ordering requires that a medical doctor (physician) is assigned to the patient.
Order URL
Test service: Help
Genotyping and Pharmacogenetic Testing
    OrderCode: IDXXXXXX
Test development: Help
Test developed by laboratory (no manufacturer test name)
Informed consent required: Help
Yes
Test strategy: Help
qPCR
View citations (1)
  • doi.org/10.1186/s12967-021-02816-3
Pre-test genetic counseling required: Help
Decline to answer
Post-test genetic counseling required: Help
Yes
Recommended fields not provided:
Test Order Code, Lab contact for this test
Conditions Help
Total conditions: 30
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 12
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; Predictive; Therapeutic management
Target population: Help
Patients of diseases of the central nervous system.
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS? Help
DNA is extracted and purified from samples and the sample is quantified by spectroscopy (NanoDrop). The test is carried out by the method SNP TaqMan qPCR on QuantStudio 12K and the bioinformatic analysis is based on an in house developed database sourcing pharmacogenetic data from international databases. The targets include … View more

Will the lab re-contact the ordering physician if variant interpretation changes? Help
Not provided.
Sample reports:
Sample Positive Report Help
Sample Positive Report
Recommended fields not provided:
Clinical validity, Clinical utility, 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
Technical Information
Test Procedure: Help
DNA extraction and purification. Quality control and quantification. Genotyping with SNP TaqMan qPCR and allelic discrimination analysis.
View citations (1)
  • doi.org/10.1186/s12967-021-02816-3
Availability: Help
Tests performed
Entire test performed in-house
Interpretation performed in-house
Report generated in-house
Specimen preparation performed in-house
Wet lab work performed in-house
Analytical Validity: Help
ISO13485, validity described on doi.org/10.1186/s12967-021-02816-3
View citations (1)
  • doi.org/10.1186/s12967-021-02816-3
Assay limitations: Help
Duplications are not included in the test
View citations (1)
  • doi.org/10.1186/s12967-021-02816-3
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
No

Method used for proficiency testing: Help
Intra-Laboratory
VUS:
Software used to interpret novel variations Help
Hi Reporter Software
Recommended fields not provided:
Test Confirmation, 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
Category: Not Applicable
Additional Information
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.