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UGT1A1 Genotyping
Clinical Genetic Test
Help
offered by
Sinochips Diagnostics
GTR Test Accession: Help GTR000597285.1
CAP
PHARMACOGENOMIC
Registered in GTR: 2022-01-05
View version history
Last annual review date for the lab: 2024-07-15 LinkOut
At a Glance
Test purpose: Help
Drug Response; Predictive; Risk Assessment
Conditions (5): Help
Atazanavir response; Belinostat response; Irinotecan response more...
Genes (1): Help
UGT1A1 (2q37.1)
Methods (1): Help
Molecular Genetics - Sequence analysis of select exons: Bi-directional Sanger Sequence Analysis
Target population: Help
Not provided
Clinical validity: Help
Not provided
Clinical utility: Help
Guidance for selecting a drug therapy and/or dose
Ordering Information
Offered by: Help
Sinochips Diagnostics
View lab's website
Test short name: Help
UGT1A1
Specimen Source: Help
  • Buccal swab
  • Isolated DNA
Who can order: Help
  • Genetic Counselor
  • Health Care Provider
  • In-State Patients
  • Licensed Physician
  • Nurse Practitioner
  • Out-of-State Patients
  • Physician Assistant
  • Public Health Mandate
  • Registered Nurse
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
Please fill in the contact form at https://sinochipsdiagnostics.com/contact/ or give us a call (877) 746-6244.
Order URL
Informed consent required: Help
Yes
Pre-test genetic counseling required: Help
Yes
Post-test genetic counseling required: Help
Yes
Recommended fields not provided:
Test Order Code, Lab contact for this test, Test strategy, Test development
Conditions Help
Total conditions: 5
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: 1
Method Category Help
Test method Help
Instrument *
Sequence analysis of select exons
Bi-directional Sanger Sequence Analysis
* Instrument: Not provided
Clinical Information
Test purpose: Help
Drug Response; Predictive; Risk Assessment
Clinical utility: Help
Guidance for selecting a drug therapy and/or dose
View citations (1)

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: Help
Tests performed
Interpretation performed in-house
Report generated in-house
Specimen preparation performed in-house
Wet lab work performed both in-house and at an outside lab

Test performance comments
Sequencing is performed by ACGT
Analytical Validity: Help
A total of 27 samples with known UGT1A1 genotype status were used for the method comparison (sensitivity and specificity) study. Analytical accuracy is 100%; Specificity is 100% and Sensitivity is 100%
Assay limitations: Help
This assay does not test for all possible DPYD DNA variants that may affect DPD enzyme function. The information contained in this report is intended to be interpreted by a licensed physician or other licensed healthcare professional. This report is not intended to take the place of professional medical advice. … View more
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
Recommended fields not provided:
Test Confirmation, Citations to support 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: Help
Not provided
Additional Information
Practice guidelines:
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.