GTR Test Accession:
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GTR000591213.1
Last updated in GTR: 2020-07-15
View version history
GTR000591213.1, last updated: 2020-07-15
Last annual review date for the lab: 2023-06-14
Past due
LinkOut
At a Glance
Test purpose:
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Predictive;
Prognostic
Conditions (1):
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Familial colorectal cancer
5 target genes based on patient's tumor are selected and tracked
Methods (1):
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Molecular Genetics - RNA analysis: PCR
Target population: Help
colorectal cancer patients that are in remission
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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ONCOD56
Specimen Source:
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- Fresh tissue
- Frozen tissue
Who can order: Help
- Health Care Provider
- Licensed Physician
Test Order Code:
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OncoDefender
CPT codes:
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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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contact GoPath client services to set up testing
Order URL
Order URL
Test service:
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molecular
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:
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
Chromosomal regions/Mitochondria
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Total chromosomal regions/mitochondria: 1
Chromosomal region/Mitochondrion | Associated condition |
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Methodology
Total methods: 1
Method Category
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Test method
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Instrument
RNA analysis
PCR
ABI 3130XL Genetic Analyzer
Clinical Information
Test purpose:
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Predictive;
Prognostic
Target population:
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colorectal cancer patients that are in remission
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS?
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Interpretation and classification of clinical significance of the detected variant are based on catalogued information from the NCBI ClinVar database (http://www.ncbi.nlm.nih.gov/clinvar/variation/), LOVD database (http://databases.lovd.nl/ shared/genes/) and other locus specific databases as well as information from published literatures
Interpretation and classification of clinical significance of the detected variant are based on catalogued information from the NCBI ClinVar database (http://www.ncbi.nlm.nih.gov/clinvar/variation/), LOVD database (http://databases.lovd.nl/ shared/genes/) and other locus specific databases as well as information from published literatures
Are family members with defined clinical status recruited to assess significance of VUS without charge?
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Yes.
Yes.
Will the lab re-contact the ordering physician if variant interpretation changes?
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Not provided. our GeneticsNow service covers it all - please use our website www.gopathlabs.com
Not provided. our GeneticsNow service covers it all - please use our website www.gopathlabs.com
Recommended fields not provided:
Clinical validity,
Clinical utility,
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:
NextGene
Availability:
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Tests performed
Entire test performed in-house
Entire test performed in-house
Analytical Validity:
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Sensitivity of the assay was determined by serial dilutions of RNA samples from a low-risk and a high-risk case with an RNA sample from a normal colon tissue. A total of 22 validation samples either in form of tissue sections or RNA was provided by Everist Health, and expressions of …
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Proficiency testing (PT):
Is proficiency testing performed for this test?
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No
Method used for proficiency testing: Help
Intra-Laboratory
PT Provider: Help
samples are sent out to other respective partner labs and we com
No
Method used for proficiency testing: Help
Intra-Laboratory
PT Provider: Help
samples are sent out to other respective partner labs and we com
VUS:
Software used to interpret novel variations
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NextGENe
Laboratory's policy on reporting novel variations Help
formal reports
NextGENe
Laboratory's policy on reporting novel variations Help
formal reports
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:
Suggested reading:
Clinical resources:
Practice guidelines:
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.