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
Not provided.
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
MGMT
Gene
LOINC Codes
- 57723-9 - Unique bar code # Current sample
- 60252-4 - MGMT gene methylation Tiss Ql
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 |
Other tests from different labs that may be relevant