GTR Test Accession:
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GTR000591183.1
Last updated in GTR: 2020-07-06
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GTR000591183.1, last updated: 2020-07-06
Last annual review date for the lab: 2023-06-14
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At a Glance
Test purpose:
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Therapeutic management
Conditions (1):
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Glioblastoma
Proteins (1):
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DNA alkytransferase
Methods (2):
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Molecular Genetics - Methylation analysis: PCR; ...
Target population: Help
patients with glioblastoma who receive alkylating agents for chemotherapy
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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BRAIN94
Specimen Source:
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- Fresh tissue
- Frozen tissue
- Paraffin block
- View specimen requirements
Who can order: Help
- Health Care Provider
- Licensed Physician
Test Order Code:
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Brain Profile
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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download PDF requisition online and contact our customer service to coordinate on how to send sample
CPT codes : 81210, 81275, 81276, 81311, 81120
Order URL
CPT codes : 81210, 81275, 81276, 81311, 81120
Order URL
Test service:
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PCR
Test development:
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Manufactured (research use only; not FDA-reviewed)
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
Conditions
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Total conditions: 1
Condition/Phenotype | Identifier |
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Test Targets
Proteins
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Total proteins: 1
Protein | Associated Condition |
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Methodology
Total methods: 2
Method Category
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Test method
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Instrument
Methylation analysis
PCR
ABI9700 GeneAmp PCR system
Sequence analysis of the entire coding region
PCR
ABI9700 GeneAmp PCR System
Clinical Information
Test purpose:
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Therapeutic management
Target population:
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patients with glioblastoma who receive alkylating agents for chemotherapy
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://0-www-ncbi-nlm-nih-gov.brum.beds.ac.uk/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://0-www-ncbi-nlm-nih-gov.brum.beds.ac.uk/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:
ABI 3130 XL Genetic Analyzer
Availability:
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Tests performed
Entire test performed in-house
Test performance comments
the only part of this test that is sent out is the 1p/19q deletion (FISH) - so this test and procedure is not listed in the panel
Entire test performed in-house
Test performance comments
the only part of this test that is sent out is the 1p/19q deletion (FISH) - so this test and procedure is not listed in the panel
Analytical Validity:
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MGMT: Sensitivity of the assay was determined by the detection of serially diluted in vitro methylated MGMT DNA sequence in the background of un-methylated DNA sequences. In vitro methylated normal lymphocyte DNA was proportionally diluted into 100%, 80%, 60%, 20% and 10% using un-methylated normal lymphocyte DNA and bisulfite DNA …
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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
Formal PT program
PT Provider: Help
CAP
No
Method used for proficiency testing: Help
Formal PT program
PT Provider: Help
CAP
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:
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.