GTR Test Accession:
Help
GTR000529070.6
Last updated in GTR: 2021-10-26
View version history
GTR000529070.6, last updated: 2021-10-26
GTR000529070.5, last updated: 2021-10-22
GTR000529070.4, last updated: 2020-10-20
GTR000529070.3, last updated: 2018-12-17
GTR000529070.2, last updated: 2017-12-17
GTR000529070.1, last updated: 2016-12-18
Last annual review date for the lab: 2022-10-27
Past due
LinkOut
At a Glance
Methods (1):
Help
Molecular Genetics - Methylation analysis: Next Generation Sequencing
Target population: Help
Patients with glioblastoma
Clinical validity:
Help
Not provided
Clinical utility:
Help
Guidance for selecting a drug therapy and/or dose
Ordering Information
Offered by:
Help
Test short name:
Help
MGMT
Specimen Source:
Help
- Slides with paraffin-embedded sections
- View specimen requirements
Who can order: Help
- Licensed Physician
Test Order Code:
Help
MGMT
Lab contact:
Help
Contact Policy:
Help
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:
Help
Test development:
Help
Test developed by laboratory (no manufacturer test name)
Informed consent required:
Help
Decline to answer
Pre-test genetic counseling required:
Help
Decline to answer
Post-test genetic counseling required:
Help
Decline to answer
Recommended fields not provided:
Test strategy
Conditions
Help
Total conditions: 1
Condition/Phenotype | Identifier |
---|
Test Targets
Genes
Help
Total genes: 1
Gene | Associated Condition | Germline or Somatic | Allele (Lab-provided) | Variant in NCBI |
---|
Methodology
Total methods: 1
Method Category
Help
Test method
Help
Instrument *
Methylation analysis
Next Generation Sequencing
* Instrument: Not provided
Clinical Information
Test purpose:
Help
Prognostic
Clinical utility:
Help
Guidance for selecting a drug therapy and/or dose
View citations (1)
- MGMT gene silencing and benefit from temozolomide in glioblastoma. Hegi ME, et al. N Engl J Med. 2005;352(10):997-1003. doi:10.1056/NEJMoa043331. PMID: 15758010.
Target population:
Help
Patients with glioblastoma
Recommended fields not provided:
Clinical validity,
What is the protocol for interpreting a variation as a VUS?,
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 Comments:
Help
The addition of a methyl group to the O6 position of guanine is a mutagenic event that is corrected by a DNA repair protein encoded by the MGMT gene. If the MGMT repair mechanism fails to occur, cells will undergo apoptosis and thus become more susceptible to drug induced-cytotoxicity. In …
View more
Availability:
Help
Tests performed
Entire test performed in-house
Entire test performed in-house
Analytical Validity:
Help
Methylation of 17 individual CpG methylation sites across a promoter region of 191 bp is determined by Next Generation Sequencing.
Assay limitations:
Help
Infiltrating normal tissue in tumor sections may reduce the detection of methylation CpG sites. Tumor-rich areas should be circled on an H&E stained paraffin section.
Proficiency testing (PT):
Is proficiency testing performed for this test?
Help
Yes
Method used for proficiency testing: Help
Intra-Laboratory
Yes
Method used for proficiency testing: Help
Intra-Laboratory
Recommended fields not provided:
Test Confirmation,
Citations to support 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:
Help
Category:
FDA exercises enforcement discretion
Additional Information
Reviews:
Clinical resources:
Practice guidelines:
Consumer resources:
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.