GTR Test Accession:
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GTR000597429.1
Registered in GTR:
2022-03-28
View version history
GTR000597429.1,
registered in GTR:
2022-03-28
Last annual review date for the lab: 2024-08-09
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At a Glance
Test purpose:
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Drug Response;
Prognostic;
Risk Assessment; ...
Conditions (45):
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Genes (34):
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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
Any person affected by cancer
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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CHP
Manufacturer's name:
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Ion AmpliSeq™ Cancer Hotspot Panel
Specimen Source:
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- Cell-free DNA
- Isolated DNA
- Paraffin block
Who can order: Help
- Genetic Counselor
- Licensed Physician
Test Order Code:
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CHP
Lab contact:
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Shahram Savad, PhD, MD, Lab Director
Contact Policy:
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Post-test email/phone consultation regarding genetic test results and interpretation is provided to patients/families.
Pre-test email/phone consultation regarding genetic test results and interpretation is provided to patients/families.
Pre-test email/phone consultation regarding genetic test results and interpretation is provided to patients/families.
Test service:
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Genetic counseling
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:
How to Order,
Test strategy,
Test development
Conditions
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Total conditions: 45
Condition/Phenotype | Identifier |
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Test Targets
Genes
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Total genes: 34
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)
Ion Torrent Proton
Clinical Information
Test purpose:
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Drug Response;
Prognostic;
Risk Assessment;
Therapeutic management
Target population:
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Any person affected by cancer
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS?
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According to ACMG guidelines
According to ACMG guidelines
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,
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 Platform:
Ion semiconductor sequencing
Availability:
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Tests performed
Entire test performed in-house
Entire test performed in-house
Analytical Validity:
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98% detection rate for 5% variant frequency at
positions with average sequencing coverage
from 1,000X to 4,000X
Proficiency testing (PT):
Is proficiency testing performed for this test?
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No
No
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
Clinical resources:
Molecular resources:
Practice guidelines:
IMPORTANT NOTE:
NIH does not independently verify information submitted to GTR; it relies on submitters to provide information that is accurate and not misleading.
NIH makes no endorsements of tests or laboratories listed in GTR. GTR is not a substitute for medical advice.
Patients and consumers
with specific questions about a genetic test should contact a health care provider or a genetics professional.