GTR Test Accession:
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GTR000591201.1
Registered in GTR:
2020-07-10
View version history
GTR000591201.1,
registered in GTR:
2020-07-10
Last annual review date for the lab: 2023-06-14
Past due
LinkOut
At a Glance
Test purpose:
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Therapeutic management
Conditions (1):
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Ovarian cancer
Genes (1):
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KRAS (12p12.1)
Methods (1):
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Molecular Genetics - Mutation scanning of the entire coding region: PCR
Target population: Help
females with ovarian 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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KRAS-99
Specimen Source:
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- Fresh tissue
- Frozen tissue
- Paraffin block
Who can order: Help
- Health Care Provider
- Licensed Physician
Test Order Code:
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KRAS
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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Test service:
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molecular genomic testing
Comment: KRAS
Comment: KRAS
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
Genes
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Total genes: 1
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
Mutation scanning of the entire coding region
PCR
ABI 3130XL Genetic Analyzer
Clinical Information
Test purpose:
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Therapeutic management
Target population:
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females with ovarian cancer
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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A total of 56 FFPE specimens were used for this study. All 56 FFPE specimens were extracted using our manual DNA extraction manual procedure and sequenced by conventional sequencing. Of these 20 specimens were from Reference Laboratory 1 and the rest 36 specimens were from Reference Laboratory 2. The sequencing …
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Proficiency testing (PT):
Is proficiency testing performed for this test?
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No
No
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,
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
Reviews:
Clinical resources:
Molecular resources:
Practice guidelines:
Consumer resources:
IMPORTANT NOTE:
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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.