GTR Test Accession:
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GTR000527837.1
Registered in GTR:
2015-08-16
View version history
GTR000527837.1,
registered in GTR:
2015-08-16
Last annual review date for the lab: 2024-05-22
LinkOut
At a Glance
Test purpose:
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Diagnosis;
Prognostic;
Risk Assessment; ...
Conditions (23):
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1q, 3p21, 5q31
Genes (92):
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Methods (2):
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Molecular Genetics - Deletion/duplication analysis: Microarray; ...
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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Test short name:
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Kancerray
Specimen Source:
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- Bone marrow
- Frozen tissue
- Isolated DNA
- tumor biopsy
- Peripheral (whole) blood
Who can order: Help
- Health Care Provider
How to Order:
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For more information, please contact the laboratory directly.
Informed consent required:
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Decline to answer
Pre-test genetic counseling required:
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Decline to answer
Post-test genetic counseling required:
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Decline to answer
Recommended fields not provided:
Test Order Code,
Lab contact for this test,
Contact policy,
Test strategy,
Test development
Conditions
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Total conditions: 23
Condition/Phenotype | Identifier |
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Test Targets
Chromosomal regions/Mitochondria
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Total chromosomal regions/mitochondria: 1
Chromosomal region/Mitochondrion | Associated condition |
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Genes
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Total genes: 92
Gene | Associated Condition | Germline or Somatic | Allele (Lab-provided) | Variant in NCBI |
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Methodology
Total methods: 2
Method Category
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Test method
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Instrument *
Deletion/duplication analysis
Microarray
Detection of homozygosity
Microarray
* Instrument: Not provided
Clinical Information
Test purpose:
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Diagnosis;
Prognostic;
Risk Assessment;
Therapeutic management
Recommended fields not provided:
Clinical validity,
Clinical utility,
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
Test Comments:
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For a specific gene information, please contact the laboratory directly.
Availability:
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Tests performed
Entire test performed in-house
Entire test performed in-house
Analytical Validity:
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This test is evaluated for analytical validity using an established validation process utilizing abnormal and normal specimens as per CAP, ACMG, and CLIA guidelines. Microarray platform includes oligonucleotide probes for the 898 genes known to be involved in carcinogenesis, subtelomeric, pericentromeric regions, as well as breakpoint “hot spot” intervals associated …
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Assay limitations:
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Although microarray detects microscopic and submicroscopic deletions and duplications undetectable by karyotyping, microarray will not detect balanced chromosome rearrangements, such as balanced translocations or inversions. It will not detect alterations in chromosome structure at areas of the genome not covered by the array. This technology will not detect sequence alterations …
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Proficiency testing (PT):
Is proficiency testing performed for this test?
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No
Description of internal test validation method: Help
Karyotype, FISH analysis
No
Description of internal test validation method: Help
Karyotype, FISH analysis
Recommended fields not provided:
Test Confirmation,
Citations to support assay limitations,
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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Not provided
Additional Information
Clinical resources:
Practice guidelines:
Consumer resources:
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Patients and consumers
with specific questions about a genetic test should contact a health care provider or a genetics professional.