MGMT Methylation Detection by PCR

Label Mnemonic:	MGMT
Epic code:	LAB8110
Downtime form:	A-1a Doctor/Provider Orders - Pathology Core and Specialty Care Nursery

Commercial Mailout Laboratory
6240-8 RCP
356-8593

Specimen(s):

Tumor Tissue

Collection Medium:

	or
Tissue Block	or	Sterile Container

Minimum:

Formalin fix (10 percent neutral buffered formalin) and paraffin embed tissue. Protect from excessive heat. Transport tissue block or 5 unstained 5-micron slides. (Min: 3 slides)

Rejection Criteria:

Specimens fixed/processed in alternative fixatives (alcohol, Prefer) or heavy metal fixatives (B-4 or B-5). Decalcified specimens. Less than 25 percent tumor.

Turn Around Time:

10-12 days upon receipt at reference laboratory

Interpretive Data:

Sensitivity/specificity:
Analytical sensitivity - limit of detection is methylation levels >1%
Analytical specificity - 100%

Results:
Positive - MGMT promoter methylation was detected
   Associated with improved survival in individuals
   with glioma and in those treated with alkylating
   agents
Not detected - MGMT promoter methylation not detected

Comments:

Test Aids in therapeutic decisions in individuals with gliomas. Methylation of MGMT gene is a favorable prognostic factor in glial tumors.

Include surgical pathology report. Tissue block will be returned after testing.

Test Limitations:

*Methylation at locations other than those covered by the primers and probes not detected

*Results of this test must always be interpreted within the clinical context and other relevant data

*Results should not be used as a sole determinant of alkylating chemotherapy in standard clinical practice

Methodology:

Real-Time Polymerase Chain Reaction/Fluorescence Resonance Energy Transfer

CPT Code:

88381, 81287