MGMT Promoter Methylation Analysis, Tumor

Test Code

17863

CPT Codes
81287

Includes

When this test is ordered, slide review will always be performed at an additional charge (CPT code(s): 88381).

Preferred Specimen

Tissue block- formalin-fixed non-decalcified, paraffin-embedded tissue block.
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)

Other Acceptable Specimens

1 stained and 10 unstained (5 unstained slides at 5-microns thickness minimum) tissue slide

Instructions

Please note: This assay requires at least 20% tumor nuclei.

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 Type: Tissue block
Submit a formalin-fixed non-decalcified, paraffin-embedded tissue block.

Specimen Type: Tissue slide
Slides: 1 Stained and 10 unstained
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

Transport Temperature

Room temperature

Specimen Stability

Room temperature: Varies
Refrigerated: Not established
Frozen: Not established

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Specimens that have been decalcified (all methods) • Specimens that have not been formalin-fixed, paraffin-embedded • Extracted nucleic acid (DNA/RNA)

Methodology
Droplet Digital Polymerase Chain Reaction (ddPCR)

FDA Status
This test was developed, and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.

Setup Schedule

Set up: Varies; Report available: 7-10 days

Reference Range

See Laboratory Report

Clinical Significance

• Prognostication of newly diagnosed patients with glioblastoma
• Identification of newly diagnosed glioblastoma patients that may derive benefit from alkylating chemotherapy (i.e., temozolomide)
• Therapy selection for newly diagnosed glioblastoma in older patients (>60-65 years)

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.