GTR Test Accession:
Help
GTR000552573.10
CAP
Last updated in GTR:
2024-02-27
View version history
GTR000552573.10,
last updated:
2024-02-27
GTR000552573.9,
last updated:
2023-04-26
GTR000552573.8,
last updated:
2023-03-23
GTR000552573.7,
last updated:
2022-11-22
GTR000552573.6,
last updated:
2021-11-24
GTR000552573.5,
last updated:
2020-11-29
GTR000552573.4,
last updated:
2019-12-09
GTR000552573.3,
last updated:
2019-06-11
GTR000552573.2,
last updated:
2018-07-06
GTR000552573.1,
registered in GTR:
2017-07-03
Last annual review date for the lab: 2024-02-27
LinkOut
At a Glance
Methods (1):
Help
Molecular Genetics - Targeted variant analysis: SNP Detection
Target population: Help
Providers who are initiating a new medication therapy or are …
Clinical validity:
Help
Not provided
Clinical utility:
Help
Guidance for selecting a drug therapy and/or dose
Ordering Information
Offered by:
Help
Test short name:
Help
Rxight
Manufacturer's name:
Help
Rxight
Specimen Source:
Help
- Buccal swab
- View specimen requirements
Who can order: Help
- Health Care Provider
- Licensed Physician
- Nurse Practitioner
Test Order Code:
Help
Rxight Pharmacogenetics Test
View other test codes
View other test codes
Lab contact:
Help
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
Ordered by medical provider from MD Labs when there are concerns about potential medication response (ADR's or efficacy)
Order URL
Order URL
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 strategy
Conditions
Help
Total conditions: 62
Condition/Phenotype | Identifier |
---|
Test Targets
Genes
Help
Total genes: 8
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
SNP Detection
Life Technologies QuantStudio 12K Flex Real-time PCR System
Clinical Information
Test purpose:
Help
Drug Response;
Therapeutic management
Clinical utility:
Help
Target population:
Help
Providers who are initiating a new medication therapy or are concerned with existing medication therapy for a patient and have concern over drug-gene interactions.
View citations (1)
- O'Donnell PH, Danahey K, Jacobs M, Wadhwa NR, Yuen S, Bush A, Sacro Y, Sorrentino MJ, Siegler M, Harper W, Warrick A, Das S, Saner D, Corless CL, Ratain MJ. Adoption of a clinical pharmacogenomics implementation program during outpatient care--initial results of the University of Chicago "1,200 Patients Project". Am J Med Genet C Semin Med Genet. 2014;166C(1):68-75. doi:10.1002/ajmg.c.31385. Epub 2014 Mar 10. PMID: 24616296.
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS?
Help
Only variants with clinical significance are analyzed
Only variants with clinical significance are analyzed
Will the lab re-contact the ordering physician if variant interpretation changes?
Help
Not provided. N/A
Not provided. N/A
Recommended fields not provided:
Clinical validity,
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 Procedure:
Help
Redundant specimen processing and the use of standards with every analytical run. Proficiency Testing and QA performed in alignment with CLIA standards.
Test Platform:
Life Technologies OpenArray Platform
Test Confirmation:
Help
Redundant specimen processing and the use of standards with every analytical run. Proficiency Testing and QA performed in alignment with CLIA standards.
Availability:
Help
Tests performed
Interpretation performed at an outside lab
Report generated at an outside lab
Specimen preparation performed in-house
Wet lab work performed in-house
Test performance comments
Rxight pharmacogenetic reports are generated and accompanied by a companion letter from Coriell Life Sciences.
Interpretation performed at an outside lab
Report generated at an outside lab
Specimen preparation performed in-house
Wet lab work performed in-house
Test performance comments
Rxight pharmacogenetic reports are generated and accompanied by a companion letter from Coriell Life Sciences.
Analytical Validity:
Help
Accuracy: 99.37%
Reproducability/Precision: 99.32%
Proficiency testing (PT):
Is proficiency testing performed for this test?
Help
Yes
Method used for proficiency testing: Help
Formal PT program
PT Provider: Help
American College of Medical Genetics / College of American Pathologists, ACMG/CAP
CAP Testing Information Help
Pharmacogenetics; CYP2C19; PGX
Pharmacogenetics; CYP2C9; PGX
Pharmacogenetics; CYP2D6; PGX
Yes
Method used for proficiency testing: Help
Formal PT program
PT Provider: Help
American College of Medical Genetics / College of American Pathologists, ACMG/CAP
CAP Testing Information Help
Pharmacogenetics; CYP2C19; PGX
Pharmacogenetics; CYP2C9; PGX
Pharmacogenetics; CYP2D6; PGX
VUS:
Software used to interpret novel variations
Help
N/A
Laboratory's policy on reporting novel variations Help
N/A
N/A
Laboratory's policy on reporting novel variations Help
N/A
Recommended fields not provided:
Assay limitations,
Description of internal test validation method,
Citations for Analytical validity,
Description of PT method
Regulatory Approval
FDA Review:
Help
Category:
FDA exercises enforcement discretion
Additional Information
Suggested reading:
Clinical resources:
Molecular resources:
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.