GTR Test Accession:
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GTR000558437.2
CAP
Last updated in GTR:
2020-01-29
View version history
GTR000558437.2,
last updated:
2020-01-29
GTR000558437.1,
registered in GTR:
2017-10-26
Last annual review date for the lab: 2022-12-27
Past due
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At a Glance
Test purpose:
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Prognostic;
Therapeutic management
Conditions (1):
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Solid tumor
Genes (315):
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Methods (3):
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Biochemical Genetics - Immunohistochemistry: Protein Expression; ...
Target population: Help
Not provided
Clinical validity:
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Not provided
Clinical utility:
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Guidance for selecting a drug therapy and/or dose
Ordering Information
Offered by:
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Specimen Source:
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- Paraffin block
Who can order: Help
- Licensed Physician
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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Test service:
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Clinical Testing/Confirmation of Mutations Identified Previously
Pharma Services
Result interpretation
Pharma Services
Result interpretation
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,
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: 315
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 *
Immunohistochemistry
Protein Expression
Fluorescence in situ hybridization (FISH)
Fluorescence in situ hybridization (FISH)
Sequence analysis of the entire coding region
Next-Generation (NGS)/Massively parallel sequencing (MPS)
* Instrument: Not provided
Clinical Information
Test purpose:
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Prognostic;
Therapeutic management
Clinical utility:
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Guidance for selecting a drug therapy and/or dose
View citations (1)
- The NeoTYPE™ Discovery Profile for Solid Tumors is a 326 test profile that combines NGS, FISH and IHC to allow for the accurate and sensitive detection of genomic alterations in the genes most relevant to various solid tumor cancers. These genomic alterations include SNP's, indels, rearrangements and other alterations. Testing can aid in the diagnosis of various diseases and provide information to develop strategies for the treatment and management of the underlying disease. In addition, the results obtained from the NeoTYPE™ Discovery Profile for Solid Tumors can also be used in current or future clinical research projects.
Recommended fields not provided:
Clinical validity,
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
Availability:
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Tests performed
Entire test performed in-house
Entire test performed in-house
Analytical Validity:
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SNV - Sensitivity: 98.8%, Specificity: >99.9%; Indel - Sensitivity: 100%, Specificity: >99.9%; CNV - Sensitivity: 95%, Specificity: >99.9%
Proficiency testing (PT):
Is proficiency testing performed for this test?
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Yes
Method used for proficiency testing: Help
Intra-Laboratory
PT Provider: Help
American College of Medical Genetics / College of American Pathologists, ACMG/CAP
Yes
Method used for proficiency testing: Help
Intra-Laboratory
PT Provider: Help
American College of Medical Genetics / College of American Pathologists, ACMG/CAP
Recommended fields not provided:
Test Confirmation,
Assay limitations,
Description of internal test validation method,
Citations for Analytical validity,
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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with specific questions about a genetic test should contact a health care provider or a genetics professional.