GTR Test Accession:
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GTR000603515.1
Last updated in GTR: 2022-11-09
View version history
GTR000603515.1, last updated: 2022-11-09
Last annual review date for the lab: 2024-01-30
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At a Glance
Test purpose:
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Diagnosis;
Prognostic;
Therapeutic management
Conditions (1):
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Solid tumor
Genes (433):
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Methods (3):
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Molecular Genetics - Deletion/duplication analysis: Next-Generation (NGS)/Massively parallel sequencing (MPS); ...
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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- FFPE tumor
- Paraffin block
- View specimen requirements
Who can order: Help
- Health Care Provider
Test Order Code:
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OA0001
View other test codes
View other test codes
CPT codes:
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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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Informed consent required:
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Yes
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 strategy,
Test development
Conditions
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Total conditions: 1
Condition/Phenotype | Identifier |
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Test Targets
Genes
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Total genes: 433
Gene | Associated Condition | Germline or Somatic | Allele (Lab-provided) | Variant in NCBI |
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Methodology
Total methods: 3
Method Category
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Test method
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Instrument *
Deletion/duplication analysis
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Mutation scanning of select exons
Next-Generation (NGS)/Massively parallel sequencing (MPS)
RNA analysis
Next-Generation (NGS)/Massively parallel sequencing (MPS)
* Instrument: Not provided
Clinical Information
Test purpose:
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Diagnosis;
Prognostic;
Therapeutic management
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS?
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Variants are classified using in-house developed procedures, including the review of applicable functional studies. Benign and likely benign variants are not reported. Pathogenic, likely pathogenic and variants of uncertain clinical significance are reported. Variants of unknown significance (VUS) may be detected in the patient's tumor. Reported VUS may not have … View more
Variants are classified using in-house developed procedures, including the review of applicable functional studies. Benign and likely benign variants are not reported. Pathogenic, likely pathogenic and variants of uncertain clinical significance are reported. Variants of unknown significance (VUS) may be detected in the patient's tumor. Reported VUS may not have … View more
Will the lab re-contact the ordering physician if variant interpretation changes?
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Not provided.
Not provided.
Recommended fields not provided:
Clinical validity,
Clinical utility,
Target population,
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:
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Tests performed
Entire test performed in-house
Entire test performed in-house
Analytical Validity:
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The sensitivity for single nucleotide variants and small insertions and deletions less than 50 base pairs is greater than 0.97 and 0.95 respectively. Specificity for single nucleotide variants and small insertions and deletions less than 50 base pairs is greater than 0.999. The sensitivity and specificity for copy number variant …
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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:
Software used to interpret novel variations
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Claudia for Genomics™ platform
Claudia for Genomics™ platform
Recommended fields not provided:
Test Confirmation,
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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Not provided
Additional Information
Reviews:
Clinical resources:
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.