Drug Efficacy and Safety
Clinical Genetic Test
Help
offered by
GTR Test Accession: Help GTR000562019.1
PHARMACOGENOMICINHERITED DISEASEINHERITED DISEASE SUSCEPTIBILITY ... View more
Registered in GTR: 2018-10-23
Last annual review date for the lab: 2023-07-06 Past due LinkOut
At a Glance
Drug Response; Therapeutic management
Chlorpropamide-alcohol flushing; Amitriptyline response; Aripiprazole response more...
Molecular Genetics - Mutation scanning of the entire coding region: Microarray
European ancestry only.
Not provided
Not provided
Ordering Information
Test short name: Help
Pharmacogenetics
Specimen Source: Help
  • Isolated DNA
  • Peripheral (whole) blood
  • Saliva
Who can order: Help
  • Genetic Counselor
  • Health Care Provider
  • In-State Patients
  • Licensed Dentist
  • Licensed Physician
  • Nurse Practitioner
  • Out-of-State Patients
  • Physician Assistant
  • Public Health Mandate
  • Registered Nurse
Test Order Code: Help
420988
Contact Policy: Help
Pre-test email/phone consultation regarding genetic test results and interpretation is provided to patients/families.
How to Order: Help
Please contact us via e-mail or phone to place an order.

We accept DNA samples, blood and saliva samples shipped via DHL. We do not accept samples on weekdays.

Please note that due to customs regulation we need samples details before the sample is sent.
Order URL
Test service: Help
Clinical Testing/Confirmation of Mutations Identified Previously
Confirmation of research findings
Custom Deletion/Duplication Testing
Custom Sequence Analysis
Data Storage and Backup
Genetic counseling
Result interpretation
Specimen Source Identification
Test additional service: Help
Custom mutation-specific/Carrier testing
Test development: Help
Test developed by laboratory but exempt from FDA oversight (eg. NYS CLEP approved, offered within a hospital or clinic)
Informed consent required: Help
Yes
Pre-test genetic counseling required: Help
No
Post-test genetic counseling required: Help
No
Recommended fields not provided:
Conditions Help
Total conditions: 47
Condition/Phenotype Identifier
Test Targets
Chromosomal regions/Mitochondria Help
Total chromosomal regions/mitochondria: 1
Chromosomal region/Mitochondrion Associated condition
Methodology
Total methods: 1
Method Category Help
Test method Help
Instrument
Mutation scanning of the entire coding region
Microarray
Illumina HiScan™SQ system
Clinical Information
Test purpose: Help
Drug Response; Therapeutic management
Target population: Help
European ancestry only.
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS? Help
We follow ACMG guidelines for variant interpretation.

Are family members with defined clinical status recruited to assess significance of VUS without charge? Help
No.

Will the lab re-contact the ordering physician if variant interpretation changes? Help
Yes. We inform ordering physician on reinterpretation events.
Recommended fields not provided:
Technical Information
Test Platform:
Illumina Global Screening Array v. 2.0
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
Precision >99% (validated using 88 samples)
Assay limitations: Help
The assay detects SNPs only. The test does not allow to perform deletion/duplication analysis.
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
No

Method used for proficiency testing: Help
Inter-Laboratory
VUS:
Software used to interpret novel variations Help
We use clinically validated proprietary internal software.

Laboratory's policy on reporting novel variations Help
We report clinically relevant variants (both novel and reported previously) to patient. We also provide a list of all discovered mutations to clinical doctors.
Recommended fields not provided:
Regulatory Approval
FDA Review: Help
Category: FDA exercises enforcement discretion
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.