MGMT Promoter Methylation Detection by ddPCR
Also known as: MGMT METH
Use
This assay is designed to detect MGMT promoter methylation, which is a prognostic biomarker in patients with high-grade gliomas. The results aid in making treatment decisions for such individuals. MGMT promoter methylation status provides a marker that can influence the management and therapeutic approach for patients with high-grade gliomas.
Special Instructions
Include surgical pathology report with specimen shipment. Multiple specimens must either be clearly specified for independent testing or instructions must be provided to allow ARUP pathologist to select the most suitable specimen. If multiple specimens are sent without clear instructions, they will be held for clarification. Also, ensure that tumor content is higher than 25 percent, as less is unacceptable.
Limitations
The assay detects methylation specifically at CpG sites 75-78 and 79-82 of the MGMT promoter. Methylation at other locations will not be detected by this test. Furthermore, analytical sensitivity is limited to detecting 5 percent methylation. The test was developed as a Laboratory Developed Test (LDT) and is not cleared or approved by the FDA. Results should be interpreted in conjunction with other clinical and diagnostic findings.
New York Approved
Methodology
PCR-based (ddPCR)
Biomarkers
LOINC Codes
- 57723-9
- 60252-4
Result Turnaround Time
8-12 days
Related Documents
For more information, please review the documents below
Specimen
Tumor Tissue (FFPE)
Volume
Not provided
Minimum Volume
Not provided
Container
Tissue block or 5 unstained 5-micron slides
Collection Instructions
Formalin fix (10 percent neutral buffered formalin) and paraffin embed tissue. Protect from excessive heat. Use ARUP tissue transport kit (ARUP Supply #47808) for shipping.
Storage Instructions
Room temperature. Ship in cooled container during summer months.
Causes for Rejection
Less than 25 percent tumor content, specimens fixed in a non-formalin fixative, bone specimens in non-EDTA decalcifier
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Indefinitely |
| Refrigerated | Indefinitely |
| Frozen | Unacceptable |