GTR Test Accession:
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GTR000529067.2
CAP
Last updated in GTR:
2016-11-03
View version history
GTR000529067.2,
last updated:
2016-11-03
GTR000529067.1,
registered in GTR:
2015-12-28
Last annual review date for the lab: 2024-09-18
LinkOut
At a Glance
Test purpose:
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Diagnosis;
Prognostic
Conditions (1):
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Ewing sarcoma
22q12.2 EWSR1 break-apart
Methods (1):
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Cytogenetics - FISH-interphase: Fluorescence in situ hybridization (FISH)
Target population: Help
Not provided
Clinical validity:
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Not provided
Clinical utility:
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Not provided
Ordering Information
Offered by:
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Specimen Source:
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- Paraffin block
- View specimen requirements
Who can order: Help
- Genetic Counselor
- Health Care Provider
- Licensed Dentist
- Licensed Physician
- Nurse Practitioner
- Physician Assistant
- Registered Nurse
Lab contact:
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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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The requisition is found under the how to order URL. We are able to receive specimens 24 hours a day, 7 days a week. Please call the lab at 206-598-4488 for further information.
Order URL
Order URL
Test service:
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Clinical Testing/Confirmation of Mutations Identified Previously
Confirmation of research findings
Result interpretation
Confirmation of research findings
Result interpretation
Test development:
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Test developed by laboratory but exempt from FDA oversight (eg. NYS CLEP approved, offered within a hospital or clinic)
Informed consent required:
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No
Pre-test genetic counseling required:
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No
Post-test genetic counseling required:
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No
Recommended fields not provided:
Test Order Code,
Test strategy
Conditions
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Total conditions: 1
| Condition/Phenotype | Identifier |
|---|
Test Targets
Chromosomal regions/Mitochondria
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Total chromosomal regions/mitochondria: 1
| Chromosomal region/Mitochondrion | Associated condition |
|---|
Methodology
Total methods: 1
Method Category
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Test method
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Instrument *
FISH-interphase
Fluorescence in situ hybridization (FISH)
* Instrument: Not provided
Clinical Information
Test purpose:
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Diagnosis;
Prognostic
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS?
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Not applicable to this test.
Not applicable to this test.
Are family members with defined clinical status recruited to assess significance of VUS without charge?
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No. Not applicable to this test.
No. Not applicable to this test.
Will the lab re-contact the ordering physician if variant interpretation changes?
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No. Not applicable to this test.
No. Not applicable to this test.
Research:
Is research allowed on the sample after clinical testing is complete?
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No.
No.
Recommended fields not provided:
Clinical validity,
Clinical utility,
Target population,
Sample negative report,
Sample positive report
Technical Information
Availability:
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Tests performed
Entire test performed in-house
Entire test performed in-house
Analytical Validity:
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Analytical validity is 99%
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
American College of Medical Genetics / College of American Pathologists, ACMG/CAP
Description of PT method: Help
As part of CAP accreditation, proficiency testing is performed two times per year. The laboratory is provided with approximately 6 unknown specimens for testing each year, and results are returned to CAP for evaluation. The UW Cytogenetics and Genomics Laboratory has consistently participated and successfully identified the expected abnormalities in … View more
Yes
Method used for proficiency testing: Help
Formal PT program
PT Provider: Help
American College of Medical Genetics / College of American Pathologists, ACMG/CAP
Description of PT method: Help
As part of CAP accreditation, proficiency testing is performed two times per year. The laboratory is provided with approximately 6 unknown specimens for testing each year, and results are returned to CAP for evaluation. The UW Cytogenetics and Genomics Laboratory has consistently participated and successfully identified the expected abnormalities in … View more
VUS:
Software used to interpret novel variations
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Not applicable to this test.
Laboratory's policy on reporting novel variations Help
Not applicable to this test.
Not applicable to this test.
Laboratory's policy on reporting novel variations Help
Not applicable to this test.
Recommended fields not provided:
Test Confirmation,
Assay limitations,
Description of internal test validation method,
Citations for Analytical validity,
Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review:
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Category:
IUO - Investigational Use Only. The performance characteristics of this product have not been established.
FDA Review of (Item reviewed):
ASR - Analyte Specific Reagent(s)
FDA Regulatory Status:
FDA exempt
Additional Information
Reviews:
Clinical resources:
Molecular resources:
Practice guidelines:
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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.