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GeneSight CYP2D6
Clinical Genetic Test
Help
offered by
Assurex Health, Inc.
View lab's test page
LinkOut
GTR Test Accession: Help GTR000592393.1
NYS CLEP
CAP
INHERITED DISEASEINHERITED DISEASE SUSCEPTIBILITYNERVOUS SYSTEM ... View more
Registered in GTR: 2021-01-25
View version history
Last annual review date for the lab: 2024-12-29 LinkOut
At a Glance
Test purpose: Help
Drug Response; Therapeutic management
Conditions (4): Help
Major depressive disorder; Depression; Major depressive disorder 1 more...
Genes (1): Help
CYP2D6 (22q13.2)
Methods (2): Help
Molecular Genetics - Deletion/duplication analysis: PCR with electrophoresis; ...
Target population: Help
Patients taking or expecting to take neuropsychiatric medications metabolized by …
Clinical validity: Help
Not provided
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
Assurex Health, Inc.
View lab's website
View lab's test page
Specimen Source: Help
  • Buccal swab
  • Saliva
Who can order: Help
  • Health Care Provider
  • Licensed Physician
  • Nurse Practitioner
  • Physician Assistant
Lab contact: Help
Nina King, PhD, MD, HCLD(ABB), Lab Director
[email protected]
513-701-5000
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
Registered clinics may place orders by accessing MyGeneSight.com
Order URL
Test service: Help
Clinical Testing/Confirmation of Mutations Identified Previously
Custom Deletion/Duplication Testing
Test additional service: Help
Custom mutation-specific/Carrier testing
Test development: Help
Test developed by laboratory (no manufacturer test name)
Informed consent required: Help
Based on applicable state law
Pre-test genetic counseling required: Help
No
Post-test genetic counseling required: Help
No
Recommended fields not provided:
Test Order Code, Test strategy
Conditions Help
Total conditions: 4
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
Deletion/duplication analysis
PCR with electrophoresis
Targeted variant analysis
Allele-specific primer extension (ASPE)
Agena Bioscience MassArray System
Clinical Information
Test purpose: Help
Drug Response; Therapeutic management
Target population: Help
Patients taking or expecting to take neuropsychiatric medications metabolized by CYP2D6
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS? Help
N/A

Will the lab re-contact the ordering physician if variant interpretation changes? Help
Not provided.
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, Sample positive report
Technical Information
Test Platform:
Other
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
GeneSight CYP2D6 test has demonstrated accuracy and specificity of 100% with analytical and clinical sensitivity of 2.5 ng/ul for CYP2D6 deletion and duplication analyses, and 2.5 - 20 ng/ul for CYP2D6 mutation analysis.
View citations (1)
  • Jablonski MR, King N, Wang Y, Winner JG, Watterson LR, Gunselman S, Dechairo BM. Analytical validation of a psychiatric pharmacogenomic test. Per Med. 2018;15(3):189-197. doi:10.2217/pme-2017-0094. Epub 2018 Feb 07. PMID: 29739269.
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
Yes

Method used for proficiency testing: Help
Formal PT program

PT Provider: Help
College of American Pathologists, CAP
VUS:
Software used to interpret novel variations Help
N/A

Laboratory's policy on reporting novel variations Help
N/A
Recommended fields not provided:
Test Confirmation, Assay limitations, Description of internal test validation method, Description of PT method, Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review: Help
Category: FDA exercises enforcement discretion
NYS CLEP Approval: Help
Number: 8550
Status: Approved
Additional Information

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.