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HelpTest Code MGMTD MGMT Promoter Methylation Analysis, Tumor
Necessary Information
A pathology report (final or preliminary), containing the following information, is required and must accompany specimen for testing to be performed:
1. Patient name
2. Block number-must be on all blocks, slides, and paperwork (can be handwritten on the paperwork)
3. Tissue collection date
4. Source of the tissue
Specimen Required
This assay requires at least 20% tumor nuclei.
-Preferred amount of tumor area with sufficient percent tumor nuclei: tissue 144 mm(2) tissue (4 x 6 mm x 6 mm areas)
-Minimum amount of tumor area: 36 mm(2) tissue (1 x 6 mm x 6 mm area)
-These amounts are cumulative over up to 10 unstained slides and must have adequate percent tumor nuclei.
-Tissue fixation: formalin-fixed paraffin-embedded (FFPE), non-decalcified
Submit only 1 of the following specimens:
Specimen Type: Tissue block
Collection Instructions: Submit a formalin-fixed non-decalcified, paraffin-embedded tissue block.
Specimen Type: Tissue slide
Slides: 1 Stained and 10 unstained
Collection Instructions: Submit 1 slide stained with hematoxylin and eosin and 10 unstained, nonbaked slides with 5-micron thick sections of the tumor tissue.
Note: The total amount of required tumor nuclei can be obtained by scraping up to 10 slides from the same block.
Useful For
Prognostication of newly diagnosed patients with glioblastoma
Identification of newly diagnosed glioblastoma patients that may derive benefit from alkylating chemotherapy (ie, temozolomide)
Therapy selection for newly diagnosed glioblastoma in older patients (>60-65 years)
Additional Tests
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| SLIRV | Slide Review in MG | No, (Bill Only) | Yes |
Testing Algorithm
When this test is ordered, slide review will always be performed at an additional charge.
Method Name
Droplet Digital Polymerase Chain Reaction (ddPCR)
Reporting Name
MGMT Promoter Methylation AnalysisSpecimen Type
VariesSpecimen Minimum Volume
5 unstained slides at 5-microns thickness
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Varies | Ambient (preferred) | |
| Refrigerated | ||
Reference Values
An interpretive report will be provided.
Interpretation
The interpretation of molecular biomarker analysis includes an overview of the results and the associated diagnostic, prognostic, and therapeutic implications.
Clinical Reference
1. WHO Classification of Tumours Editorial Board. Central Nervous System Tumours. 5th ed. IARC Press; 2021. WHO Classification of Tumours, Vol 6
2. Hegi ME, Diserens AC, Gorlia T, et al. MGMT gene silencing and benefit from temozolomide in glioblastoma. N Engl J Med. 2005;352(10):997-1003
3. Stupp R, Hegi ME, Mason WP, et al. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol. 2009;10(5):459-66
4. Wick W, Platten M, Meisner C, et al. Temozolomide chemotherapy alone versus radiotherapy alone for malignant astrocytoma in the elderly: The NOA-08 randomised, phase 3 trial. Lancet Oncol. 2012;13(7):707-715
5. Malmstrom A, Gronberg BH, Marosi C, et al. Temozolomide versus standard 6-week radiotherapy versus hypofractionated radiotherapy in patients older than 60 years with glioblastoma: the Nordic randomised, phase 3 trial. Lancet Oncol. 2012;13(9):916-926
6. Hegi ME, Genbrugge E, Gorlia T, et al. MGMT promoter methylation cutoff with safety margin for selecting glioblastoma patients into trials omitting temozolomide: A pooled analysis of four clinical trials. Clin Cancer Res. 2019;25(6):1809-1816
7. Mansouri A, Hachem LD, Mansouri S, et al. MGMT promoter methylation status testing to guide therapy for glioblastoma: refining the approach based on emerging evidence and current challenges. Neuro Oncol. 2019;21(2):167-178
8. Wen PY, Weller M, Lee EQ, et al. Glioblastoma in adults: a Society for Neuro-Oncology (SNO) and European Society of Neuro-Oncology (EANO) consensus review on current management and future directions. Neuro Oncol. 2020;22(8):1073-1113
9. Brat DJ, Aldape K, Bridge JA, et al. Molecular biomarker testing for the diagnosis of diffuse gliomas. Arch Pathol Lab Med. 2022;146(5):547-574
10. Hegi ME, Oppong FB, Perry JR, et al. No benefit from TMZ treatment in glioblastoma with truly unmethylated MGMT promoter: Reanalysis of the CE.6 and the pooled Nordic/NOA-08 trials in elderly glioblastoma patients. Neuro Oncol. 2024;26(10):1867-1875
Day(s) Performed
Varies
Report Available
7 to 10 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Test Classification
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
81287
88381-Microdissection manual
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| MGMTD | MGMT Promoter Methylation Analysis | 60252-4 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 621859 | Result Summary | 50397-9 |
| 621860 | Result | 60252-4 |
| 621861 | Interpretation | 69047-9 |
| 621862 | Additional Information | 48767-8 |
| 621863 | Specimen | 31208-2 |
| 621864 | Source | 31208-2 |
| 621865 | Tissue ID | 80398-1 |
| 621866 | Method | 85069-3 |
| 621867 | Disclaimer | 62364-5 |
| 621868 | Released by | 18771-6 |
Forms
If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.