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FISH, UroVysion - Biliary Stricture
Clinical Genetic Test
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offered by
IU Genetic Testing Laboratories
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GTR Test Accession: Help GTR000569818.1
IMMUNOLOGYINHERITED DISEASEDIGESTIVE SYSTEM ... View more
Registered in GTR: 2019-12-30
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Last annual review date for the lab: 2024-01-10 LinkOut
At a Glance
Test purpose: Help
Prognostic
Conditions (1): Help
Primary sclerosing cholangitis
Chromosomal regions/ Mitochondria (3): Help
Chromosome 3; Chromosome 7; Chromosome 17
Methods (1): Help
Cytogenetics - FISH-interphase: Fluorescence in situ hybridization (FISH)
Target population: Help
Biliary cancer, primary sclerosing cholangitis
Clinical validity: Help
Not provided
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
IU Genetic Testing Laboratories
View lab's website
View lab's test page
Specimen Source: Help
  • Biliary Stricture
Who can order: Help
  • Genetic Counselor
  • Health Care Provider
  • Licensed Physician
  • Nurse Practitioner
Lab contact: Help
Gail Vance, MD, ABMGG Board Certified, ABP, ABPath, FCAP, Diplomate of the Ameri, Lab Director
317-278-0172
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
Order URL
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
Decline to answer
Pre-test genetic counseling required: Help
Decline to answer
Post-test genetic counseling required: Help
Decline to answer
Recommended fields not provided:
Test Order Code, Test strategy
Conditions Help
Total conditions: 1
Condition/Phenotype Identifier
Test Targets
Chromosomal regions/Mitochondria Help
Total chromosomal regions/mitochondria: 3
Chromosomal region/Mitochondrion Associated condition
Methodology
Total methods: 1
Method Category Help
Test method Help
Instrument *
FISH-interphase
Fluorescence in situ hybridization (FISH)
* Instrument: Not provided
Clinical Information
Test purpose: Help
Prognostic
Target population: Help
Biliary cancer, primary sclerosing cholangitis
View citations (1)
  • none
Recommended fields not provided:
Clinical validity, Clinical utility, 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
Entire test performed in-house
Analytical Validity: Help
This test was developed and its performance characteristics determined by the IU Cytogenetics Laboratory as required by CLIA '88 regulations. It has not been cleared or approved by the U.S. Food & Drug Administration. Additional information about testing parameters including reporting criteria is available upon request.
View citations (1)
  • none
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
Yes

Method used for proficiency testing: Help
Alternative Assessment
Recommended fields not provided:
Test Confirmation, Assay limitations, Description of internal test validation method, PT Provider, Description of PT method, Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review: Help
Not provided
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.