Clinical Genetic Test
offered by
GTR Test Accession:
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GTR000597228.1
Registered in GTR:
2021-12-14
View version history
GTR000597228.1,
registered in GTR:
2021-12-14
Last annual review date for the lab: 2024-06-14
LinkOut
At a Glance
Test purpose:
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Prognostic;
Risk Assessment;
Therapeutic management
Conditions (7):
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Gain of 1q;
Gain of 1q, 2p, 17q;
LOH at 1p, 11p15, and 17p;
LOH at 1p, 3p, 4p and 11q;
Loss of 1p, 11p15, 16q, and 17p
more...
Methods (1):
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Molecular Genetics - Deletion/duplication analysis: Microarray
Target population: Help
Individuals diagnosed with Wilms tumor or Neuroblastoma.
Clinical validity:
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Not provided
Clinical utility:
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Not provided
Ordering Information
Offered by:
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Manufacturer's name:
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Affymetrix OncoScan CNV Assay
Specimen Source:
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- Bone marrow
- Fresh tissue
- Frozen tissue
- Paraffin block
- Peripheral (whole) blood
- View specimen requirements
Who can order: Help
- Genetic Counselor
- Health Care Provider
- Licensed Physician
- Nurse Practitioner
Test Order Code:
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TONCMA
View other test codes
View other test codes
CPT codes:
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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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Samples can be accepted 7 days a week (Monday - Sunday). All samples must be labeled with minimum of two patient identifying information (e.g., Patient Name and Date of Birth). Please Submit disease-involved sample with a completed requisition form and a pathology report documenting the diagnosis. Please refer to our …
Order URL
Test development:
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Manufactured (research use only; not FDA-reviewed)
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:
Lab contact for this test,
Test strategy
Conditions
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Total conditions: 7
| Condition/Phenotype | Identifier |
|---|
Test Targets
Chromosomal regions/Mitochondria
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Total chromosomal regions/mitochondria: 7
| Chromosomal region/Mitochondrion | Associated condition |
|---|
Methodology
Total methods: 1
Method Category
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Test method
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Instrument *
Deletion/duplication analysis
Microarray
* Instrument: Not provided
Clinical Information
Test purpose:
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Prognostic;
Risk Assessment;
Therapeutic management
Target population:
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Individuals diagnosed with Wilms tumor or Neuroblastoma.
Variant Interpretation:
Are family members with defined clinical status recruited to assess significance of VUS without charge?
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No.
No.
Will the lab re-contact the ordering physician if variant interpretation changes?
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Not provided. No systemic re-evaluation of previously reported variants/findings are currently performed.
Not provided. No systemic re-evaluation of previously reported variants/findings are currently performed.
Recommended fields not provided:
Clinical validity,
Clinical utility,
What is the protocol for interpreting a variation as a VUS?,
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 Platform:
Affymetrix CytoScan HD Array
Availability:
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Tests performed
Entire test performed in-house
Entire test performed in-house
Analytical Validity:
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For regions targeted by this assay, >95% sensitivity for detecting loss/gain/LOH of the region. The sensitivity, specificity, and accuracy/precision of this assay is dependent upon the quality of the input DNA. Highly degraded DNA and contaminated DNA will yield poor results.
Assay limitations:
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Following will not be detected: genomic loss, gain, or LOH outside of the targeted regions, balanced chromosomal rearrangements
Proficiency testing (PT):
Is proficiency testing performed for this test?
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Yes
Method used for proficiency testing: Help
Intra-Laboratory
Yes
Method used for proficiency testing: Help
Intra-Laboratory
VUS:
Laboratory's policy on reporting novel variations
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Unusual or clinically significant novel variants will be communicated to the ordering provider via telephone call or email communication.
Unusual or clinically significant novel variants will be communicated to the ordering provider via telephone call or email communication.
Recommended fields not provided:
Test Confirmation,
Citations to support assay limitations,
Description of internal test validation method,
Citations for Analytical validity,
PT Provider,
Description of PT method,
Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review:
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Category:
Not Applicable
Additional Information
Reviews:
Clinical resources:
Molecular resources:
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.