Clinical Genetic Test
offered by
GTR Test Accession:
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GTR000552196.1
CAP
Last updated in GTR:
2025-01-28
View version history
GTR000552196.6,
last updated:
2021-05-07
GTR000552196.5,
last updated:
2019-10-16
GTR000552196.4,
last updated:
2018-10-05
GTR000552196.3,
last updated:
2018-01-12
GTR000552196.2,
last updated:
2018-01-11
GTR000552196.1,
registered in GTR:
2016-10-25
GTR000552196.1,
registered in GTR:
2025-01-28
Last annual review date for the lab: 2019-10-16
Past due
LinkOut
At a Glance
Test purpose:
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Diagnosis;
Prognostic;
Therapeutic management
Conditions (2):
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Hereditary cancer;
Solid tumor
Genes (606):
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Methods (1):
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Molecular Genetics - Sequence analysis of select exons: Next-Generation (NGS)/Massively parallel sequencing (MPS)
Target population: Help
Not provided
Clinical validity:
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This assay has been clinically used for diagnosis, prognosis, and …
Clinical utility:
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Not provided
Ordering Information
Test Order Code:
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HopeSeq
Lab contact:
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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:
How to Order,
Contact policy,
Test strategy,
Test development
Conditions
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Total conditions: 2
Condition/Phenotype | Identifier |
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Test Targets
Genes
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Total genes: 606
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 select exons
Next-Generation (NGS)/Massively parallel sequencing (MPS)
* Instrument: Not provided
Clinical Information
Test purpose:
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Diagnosis;
Prognostic;
Therapeutic management
Clinical validity:
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This assay has been clinically used for diagnosis, prognosis, and target therapy across all solid tumor sub-type for more than 3000 specimens per year.
View citations (1)
- De Andrade JP, Wong P, O'Leary MP, Parekh V, Amini A, Schoellhammer HF, Margolin KA, Afkhami M, Melstrom LG. Multidisciplinary Care for Melanoma of Unknown Primary: Experience in the Era of Molecular Profiling. Ann Surg Oncol. 2020;27(13):5240-5247. doi:10.1245/s10434-020-09112-2. Epub 2020 Sep 09. PMID: 32909128.
Recommended fields not provided:
Clinical utility,
Target population,
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
Test Comments:
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See https://www.cityofhope.org/clinical-molecular-diagnostic-laboratory/cmdl-test-list/hopeseq-solid-tumor-complete for assay information on genes, regarding exon mutation analysis, Copy Number Variation (CNV) analysis, and fusion analysis
Availability:
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Tests performed
Entire test performed in-house
Entire test performed in-house
Analytical Validity:
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Technical accuracy greater than 97%
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:
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Patients and consumers
with specific questions about a genetic test should contact a health care provider or a genetics professional.