GTR Test Accession:
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GTR000613392.1
CAP
Last updated in GTR: 2024-10-07
View version history
GTR000613392.1, last updated: 2024-10-07
Last annual review date for the lab: 2024-09-30
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At a Glance
Test purpose:
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Diagnosis;
Prognostic;
Therapeutic management
Conditions (15):
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Test provides MGMT methylation status to assist in the diagnostic assessment of CNS tumors.
Methods (1):
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Molecular Genetics - Methylation analysis: Quantitative PCR (qPCR)
Target population: Help
Not provided
Clinical validity:
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Not provided
Clinical utility:
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Not provided
Ordering Information
Offered by:
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Manufacturer's name:
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EZ DNA Methylation Gold, MeltDoctor HRM Master Mix
Specimen Source:
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- Formalin-fixed, paraffin-embedded (FFPE) blocks or slides
- View specimen requirements
Who can order: Help
- Genetic Counselor
- Health Care Provider
- Licensed Physician
- Nurse Practitioner
- Physician Assistant
CPT codes:
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Lab contact:
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Melissa Kelly, PhD, CC(ABB), HCLD(ABB), Lab Director
melissa.kelly@jax.org
melissa.kelly@jax.org
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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For JAX MGMT Promoter Methylation, we accept formalin-fixed, paraffin-embedded (FFPE) material only, including tumor blocks.
We require one representative hematoxylin and eosin (H&E) stained slide if possible. We require a minimum of 11 adjacent unstained 5 um sections on uncoated, unbaked slides if you are not submitting a tumor block.
We require one representative hematoxylin and eosin (H&E) stained slide if possible. We require a minimum of 11 adjacent unstained 5 um sections on uncoated, unbaked slides if you are not submitting a tumor block.
Order URL
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:
Test Order Code,
Test strategy
Conditions
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Total conditions: 15
| Condition/Phenotype | Identifier |
|---|
Test Targets
Chromosomal regions/Mitochondria
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Total chromosomal regions/mitochondria: 1
| Chromosomal region/Mitochondrion | Associated condition |
|---|
Methodology
Total methods: 1
Method Category
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Test method
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Instrument
Methylation analysis
Quantitative PCR (qPCR)
Thermo Fisher QuantStudio 7
Clinical Information
Test purpose:
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Diagnosis;
Prognostic;
Therapeutic management
Variant Interpretation:
Are family members with defined clinical status recruited to assess significance of VUS without charge?
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No.
No.
Will the lab re-contact the ordering physician if variant interpretation changes?
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No. The lab does not re-contact the ordering physicians as routine practice.
No. The lab does not re-contact the ordering physicians as routine practice.
Sample reports:
Sample Positive Report
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Pending Approval
Pending Approval
Recommended fields not provided:
Clinical validity,
Clinical utility,
Target population,
What is the protocol for interpreting a variation as a VUS?,
Is research allowed on the sample after clinical testing is complete?,
Sample negative report
Technical Information
Test Procedure:
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The JAX MGMT Promoter Methylation Assay utilizes a quantitative PCR (qPCR) followed by high-resolution melt analysis (HRM) to identify MGMT promoter methylation. Genomic DNA is extracted from FFPE tissues (minimum 30% neoplastic content) and bisulfite treated using the EZ DNA Methylation-Gold Kit (Zymo). The bisulfite-treated DNA is amplified via qPCR …
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Test Platform:
EZ DNA Methylation Gold, MeltDoctor HRM Master Mix
Availability:
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Tests performed
Entire test performed in-house
Entire test performed in-house
Analytical Validity:
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During validation, we determined with 100% accuracy, sensitivity and specificity, that specimens with ratios above a 15% methylated control will be interpreted as MGMT Promoter Methylated and specimen with ratios between unmethylated and 15% will be interpreted as Indeterminate. Specimens are interpreted as “MGMT Promoter Unmethylated” if the methylated/unmethylated ratio …
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Proficiency testing (PT):
Is proficiency testing performed for this test?
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Yes
Method used for proficiency testing: Help
Formal PT program
PT Provider: Help
College of American Pathologists, CAP
CAP Testing Information Help
Glioma; MGMT; GLI
Yes
Method used for proficiency testing: Help
Formal PT program
PT Provider: Help
College of American Pathologists, CAP
CAP Testing Information Help
Glioma; MGMT; GLI
Recommended fields not provided:
Test Confirmation,
Assay limitations,
Description of internal test validation method,
Citations for Analytical validity,
Description of PT method
Regulatory Approval
FDA Review:
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Category:
FDA exercises enforcement discretion
Additional Information
Reviews:
Clinical resources:
Practice guidelines:
Consumer resources:
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with specific questions about a genetic test should contact a health care provider or a genetics professional.