GTR Test Accession:
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GTR000576340.3
NYS CLEP
CAP
Last updated in GTR:
2023-04-10
View version history
GTR000576340.3,
last updated:
2023-04-10
GTR000576340.2,
last updated:
2022-04-15
GTR000576340.1,
registered in GTR:
2020-04-09
Last annual review date for the lab: 2024-04-09
LinkOut
At a Glance
Test purpose:
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Drug Response;
Therapeutic management
Conditions (2):
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Major depressive disorder;
Anxiety
Genes (11):
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Methods (2):
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Molecular Genetics - Deletion/duplication analysis: Quantitative PCR (qPCR); ...
Target population: Help
Not provided
Clinical validity:
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Not provided
Clinical utility:
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Guidance for selecting a drug therapy and/or dose
Ordering Information
Offered by:
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Specimen Source:
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- Buccal swab
- View specimen requirements
Who can order: Help
- Health Care Provider
- Licensed Physician
- Nurse Practitioner
- Physician Assistant
Lab contact:
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Curtis McGuyer, MD, ABPath, Lab Associate Director
cmcguyer@castlebiosciences.com
cmcguyer@castlebiosciences.com
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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AltheaDX/Castle Biosciences provides healthcare providers the option to submit orders manually by completing the IDgenetix test requisition form or by submitting orders electronically through the IDgenetix web portal.
Order URL
Order URL
Informed consent required:
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Yes
Pre-test genetic counseling required:
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No
Post-test genetic counseling required:
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No
Recommended fields not provided:
Test Order Code,
Test strategy,
Test development
Conditions
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Total conditions: 2
| Condition/Phenotype | Identifier |
|---|
Test Targets
Genes
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Total genes: 11
| Gene | Associated Condition | Germline or Somatic | Allele (Lab-provided) | Variant in NCBI |
|---|
Methodology
Total methods: 2
Method Category
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Test method
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Instrument *
Deletion/duplication analysis
Quantitative PCR (qPCR)
Targeted variant analysis
SNP Detection
* Instrument: Not provided
Clinical Information
Test purpose:
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Drug Response;
Therapeutic management
Clinical utility:
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Guidance for selecting a drug therapy and/or dose
View citations (1)
- Bradley P, Shiekh M, Mehra V, Vrbicky K, Layle S, Olson MC, Maciel A, Cullors A, Garces JA, Lukowiak AA. Improved efficacy with targeted pharmacogenetic-guided treatment of patients with depression and anxiety: A randomized clinical trial demonstrating clinical utility. J Psychiatr Res. 2018;96:100-107. doi:10.1016/j.jpsychires.2017.09.024. Epub 2017 Sep 23. PMID: 28992526.
Recommended fields not provided:
Clinical validity,
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:
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Tests performed
Entire test performed in-house
Entire test performed in-house
Analytical Validity:
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Both accuracy and precision are greater than 99.9% for the NeuroIDgenetix test.
Proficiency testing (PT):
Is proficiency testing performed for this test?
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Yes
Method used for proficiency testing: Help
Inter-Laboratory
PT Provider: Help
American College of Medical Genetics / College of American Pathologists, ACMG/CAP
Yes
Method used for proficiency testing: Help
Inter-Laboratory
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
NYS CLEP Approval:
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Number:
9184
Status: Approved
Status: Approved
Additional Information
Reviews:
Clinical resources:
Practice guidelines:
Consumer resources:
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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.