GTR Test Accession:
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GTR000556857.5
CAP
Last updated in GTR: 2020-01-09
View version history
GTR000556857.5, last updated: 2020-01-09
GTR000556857.4, last updated: 2020-01-02
GTR000556857.3, last updated: 2019-01-03
GTR000556857.2, last updated: 2018-01-04
GTR000556857.1, last updated: 2017-09-07
Last annual review date for the lab: 2024-06-14
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At a Glance
Test purpose:
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Diagnosis;
Drug Response;
Predictive; ...
Conditions (1):
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Solid tumor
Genes (523):
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Methods (1):
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Molecular Genetics - Sequence analysis of the entire coding region: Next-Generation (NGS)/Massively parallel sequencing (MPS)
Target population: Help
Patients with advanced solid tumors.
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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ProvSeq
Manufacturer's name:
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Illumina TruSight Oncology 500
Specimen Source:
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- Paraffin block
- View specimen requirements
Who can order: Help
- Health Care Provider
Test Order Code:
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LAB24400
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:
How to Order,
Lab contact for this test,
Contact policy,
Test strategy
Conditions
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Total conditions: 1
Condition/Phenotype | Identifier |
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Test Targets
Genes
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Total genes: 523
Gene | Associated Condition | Germline or Somatic | Allele (Lab-provided) | Variant in NCBI |
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Methodology
Total methods: 1
Method Category
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Test method
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Instrument
Sequence analysis of the entire coding region
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Illumina NovaSeq 6000
Clinical Information
Test purpose:
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Diagnosis;
Drug Response;
Predictive;
Prognostic;
Recurrence;
Therapeutic management
Target population:
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Patients with advanced solid tumors.
Recommended fields not provided:
Clinical validity,
Clinical utility,
What is the protocol for interpreting a variation as a VUS?,
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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In clinical samples, this test has been shown to detect >95% of Single Nucleotide Polymorphisms within the reportable range at allelic frequencies of 5%. The limit of detection for the method to accurately call insertions and deletions is 10% allelic frequency. The limit of detection for gene copy number amplification …
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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
Formal PT program
PT Provider: Help
American College of Medical Genetics / College of American Pathologists, ACMG/CAP
Yes
Method used for proficiency testing: Help
Formal PT program
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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Category:
FDA exercises enforcement discretion
Additional Information
Reviews:
Clinical resources:
Consumer resources:
IMPORTANT NOTE:
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Patients and consumers
with specific questions about a genetic test should contact a health care provider or a genetics professional.