GTR Test Accession:
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GTR000523653.13
NYS CLEP
CAP
Last updated in GTR: 2023-11-21
View version history
GTR000523653.13, last updated: 2023-11-21
GTR000523653.12, last updated: 2022-12-15
GTR000523653.11, last updated: 2022-01-03
GTR000523653.10, last updated: 2021-01-21
GTR000523653.9, last updated: 2020-01-23
GTR000523653.8, last updated: 2019-10-28
GTR000523653.7, last updated: 2019-10-23
GTR000523653.6, last updated: 2019-02-24
GTR000523653.5, last updated: 2019-02-20
GTR000523653.4, last updated: 2019-02-19
GTR000523653.3, last updated: 2019-01-24
GTR000523653.2, last updated: 2018-02-23
GTR000523653.1, last updated: 2015-07-06
Last annual review date for the lab: 2023-11-21
LinkOut
At a Glance
Test purpose:
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Drug Response;
Therapeutic management
Conditions (14):
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Major depressive disorder; Anxiety; Attention deficit hyperactivity disorder; ...
Genes (27):
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ABCB1 (7q21.12), ABCG2 (4q22.1), ADRA2A (10q25.2), ANK3 (10q21.2), BDNF (11p14.1), ...
Methods (1):
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Molecular Genetics - Targeted variant analysis: Quantitative PCR (qPCR)
Target population: Help
Psychiatric population
Polypharmacy
Clinical validity:
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In the field of pharmacogenetics, one aspect of clinical validity …
Clinical utility:
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Guidance for management;
Guidance for selecting a drug therapy and/or dose;
Healthcare Cost Savings; ...
Ordering Information
Offered by:
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Genomind, Inc.
View lab's test page
View lab's test page
Test short name:
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Genomind PGx
Specimen Source:
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- Buccal swab
- View specimen requirements
Who can order: Help
- Health Care Provider
- Licensed Physician
- Nurse Practitioner
- Physician Assistant
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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Treating clinicians with prescribing rights may order the test directly from www.genomind.com, by phone at 1-877-895-8658, or by emailing customerservice@genomind.com.
Order URL
Order URL
Test service:
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Clinical Testing/Confirmation of Mutations Identified Previously
Comment: Pharmacogenetic testing
Custom Deletion/Duplication Testing
Result interpretation
Comment: Pharmacogenetic testing
Custom Deletion/Duplication Testing
Result interpretation
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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Testing of all 26 genes on the panel is done simultaneously. If one gene fails to produce results reflex testing is performed where applicable and provider is notified if this will delay the turn-around time of the test. If additional testing cannot be performed due to poor sample quality or …
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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
Conditions
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Total conditions: 14
| Condition/Phenotype | Identifier |
|---|
Test Targets
Genes
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Total genes: 27
| Gene | Associated Condition | Germline or Somatic | Allele (Lab-provided) | Variant in NCBI |
|---|
Methodology
Total methods: 1
Method Category
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Test method
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Instrument
Targeted variant analysis
Quantitative PCR (qPCR)
QuantStudio 12k Flex Real Time Instrument
QuantStudio 7K FLEX Real Time Instrument
QuantStudio 7K FLEX Real Time Instrument
Clinical Information
Test purpose:
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Drug Response;
Therapeutic management
Clinical validity:
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In the field of pharmacogenetics, one aspect of clinical validity is the strength of the association between the genetic variant and the drug outcome in question. The following citations are key studies assessing drug-gene pair associations.
View citations (15)
- Hicks JK, Bishop JR, Sangkuhl K, Müller DJ, Ji Y, Leckband SG, Leeder JS, Graham RL, Chiulli DL, LLerena A, Skaar TC, Scott SA, Stingl JC, Klein TE, Caudle KE, Gaedigk A, . Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for CYP2D6 and CYP2C19 Genotypes and Dosing of Selective Serotonin Reuptake Inhibitors. Clin Pharmacol Ther. 2015;98(2):127-34. doi:10.1002/cpt.147. Epub 2015 Jun 29. PMID: 25974703.
- Hicks JK, Sangkuhl K, Swen JJ, Ellingrod VL, Müller DJ, Shimoda K, Bishop JR, Kharasch ED, Skaar TC, Gaedigk A, Dunnenberger HM, Klein TE, Caudle KE, Stingl JC. Clinical pharmacogenetics implementation consortium guideline (CPIC) for CYP2D6 and CYP2C19 genotypes and dosing of tricyclic antidepressants: 2016 update. Clin Pharmacol Ther. 2017;102(1):37-44. doi:10.1002/cpt.597. Epub 2017 Feb 13. PMID: 27997040.
- https://www.ncbi.nlm.nih.gov/pubmed/?term=18982004
- https://www.ncbi.nlm.nih.gov/pubmed/?term=20194480
- https://www.ncbi.nlm.nih.gov/pubmed/?term=21121776
- https://www.ncbi.nlm.nih.gov/pubmed/?term=22137564
- https://www.ncbi.nlm.nih.gov/pubmed/?term=22515274
- https://www.ncbi.nlm.nih.gov/pubmed/?term=23733030
- https://www.ncbi.nlm.nih.gov/pubmed/?term=24034787
- https://www.ncbi.nlm.nih.gov/pubmed/?term=24458010
- https://www.ncbi.nlm.nih.gov/pubmed/?term=24525690
- https://www.ncbi.nlm.nih.gov/pubmed/?term=25231750
- https://www.ncbi.nlm.nih.gov/pubmed/?term=29282363
- https://www.ncbi.nlm.nih.gov/pubmed/?term=30028366
- https://www.ncbi.nlm.nih.gov/pubmed/?term=30388593
Clinical utility:
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Guidance for management
Guidance for selecting a drug therapy and/or dose
Healthcare Cost Savings
Lifestyle planning
View citations (3)
- Pharmacogenetic-guided psychiatric intervention associated with increased adherence and cost savings. Fagerness J, et al. Am J Manag Care. 2014;20(5):e146-56. PMID: 25326929.
- https://www.personalizedmedpsych.com/article/S2468-1717(17)30027-3/fulltext
- https://www.personalizedmedpsych.com/article/S2468-1717(17)30027-3/fulltext
Guidance for selecting a drug therapy and/or dose
View citations (5)
- https://www.omicsonline.org/open-access/patient-with-major-depressive-disorder-responds-to-lmethylfolate-postgenetic-testing-2167-1044-3-156.php?aid=24982
- https://www.ncbi.nlm.nih.gov/pubmed/?term=24441311
- https://www.ncbi.nlm.nih.gov/pubmed/?term=24744941
- https://www.ncbi.nlm.nih.gov/pubmed/?term=25916515
- https://www.omicsonline.org/open-access/patient-with-major-depressive-disorder-responds-to-lmethylfolate-postgenetic-testing-2167-1044-3-156.php?aid=24982
Healthcare Cost Savings
Lifestyle planning
Target population:
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Psychiatric population
Polypharmacy
View citations (2)
- Brennan FX, Gardner KR, Lombard J, Perlis RH, Fava M, Harris HW, Scott R. A Naturalistic Study of the Effectiveness of Pharmacogenetic Testing to Guide Treatment in Psychiatric Patients With Mood and Anxiety Disorders. Prim Care Companion CNS Disord. 2015;17(2). doi:10.4088/PCC.14m01717. Epub 2015 Apr 16. PMID: 26445691.
- Perlis RH, Mehta R, Edwards AM, Tiwari A, Imbens GW. Pharmacogenetic testing among patients with mood and anxiety disorders is associated with decreased utilization and cost: A propensity-score matched study. Depress Anxiety. 2018;35(10):946-952. doi:10.1002/da.22742. Epub 2018 May 07. PMID: 29734486.
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS?
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When a rare variation not defined within our proprietary algorithm occurs, a dedicated scientific team performs a thorough review of available published literature.
When a rare variation not defined within our proprietary algorithm occurs, a dedicated scientific team performs a thorough review of available published literature.
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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No.
No.
Recommended fields not provided:
Is research allowed on the sample after clinical testing is complete?,
Sample negative report,
Sample positive report
Technical Information
Test Platform:
Other
Test Confirmation:
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Testing is performed in duplicate
Availability:
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Tests performed
Entire test performed in-house
Entire test performed in-house
Analytical Validity:
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Analytical accuracy and reproducibility is greater than 99% for the Genomind Pharmacogenetic assay.
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
CAP Testing Information Help
Pharmacogenetics; CYP2C19; PGX
Yes
Method used for proficiency testing: Help
Formal PT program
PT Provider: Help
College of American Pathologists, CAP
CAP Testing Information Help
Pharmacogenetics; CYP2C19; PGX
VUS:
Software used to interpret novel variations
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None
Laboratory's policy on reporting novel variations Help
The novel result is listed as indeterminate on the results report, and an email communication and/or a phone consultation is utilized to relay results.
None
Laboratory's policy on reporting novel variations Help
The novel result is listed as indeterminate on the results report, and an email communication and/or a phone consultation is utilized to relay results.
Recommended fields not provided:
Assay limitations,
Description of internal test validation method,
Citations for Analytical validity,
Description of PT method
Regulatory Approval
FDA Review:
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Category:
FDA exercises enforcement discretion
NYS CLEP Approval:
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Number:
9035
Status: Approved
Status: Approved
Additional Information
Reviews:
Clinical resources:
Practice guidelines:
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.