What is MGMT?

MGMT (O6-methylguanine-DNA methyltransferase) is a DNA repair enzyme that protects cells from damage caused by alkylating chemotherapy. It works by removing methyl groups from guanine bases, reversing the cytotoxic effects of agents like Temozolomide (TMZ). In many glioblastoma cases, the promoter region of the gene becomes methylated, which silences gene expression.

As a result, tumor cells lose their ability to repair chemotherapy-induced DNA damage, making them more sensitive to treatment. Assessing the methylation status of the promoter helps clinicians personalize therapy and improve outcomes.

Clinical Significance of MGMT Methylation

Methylation of the MGMT gene promoter is a key predictive biomarker in glioblastoma. When the promoter is methylated, the gene is transcriptionally inactive, limiting DNA repair. This enhances tumor sensitivity to alkylating agents, which can improve progression-free survival in affected patients.

Conversely, tumors with unmethylated MGMT remain resistant to treatment due to active DNA repair mechanisms. Therefore, accurate detection of MGMT methylation is essential for optimizing therapeutic strategies in neuro-oncology.

About the TRUPCR® MGMT Methylation Kit

The TRUPCR® Methylation Detection Kit is a CE-IVD marked qPCR test that identifies whether the MGMT promoter is methylated or unmethylated. After bisulfite conversion of DNA, the assay uses allele-specific primers and fluorescent probes (FAM and HEX) to amplify the modified DNA sequences.

An internal β-actin control verifies DNA integrity and processing success. The test is compatible with major real-time PCR systems and supports consistent, reliable analysis in diagnostic workflows. Optional interpretation software (RUO) can automatically flag amplification issues, detect threshold anomalies, and generate reports, although it is not part of the IVD-certified workflow.

How the Assay Works

1. Bisulfite Treatment: DNA is treated to convert unmethylated cytosines into uracils, leaving methylated ones unchanged.
2. PCR Amplification: Specific primers amplify methylated and unmethylated promoter sequences.
3. Fluorescent Detection: Probes labeled with FAM and HEX provide real-time monitoring.
4. Internal Control: β-actin ensures sample quality across the workflow.
5. Optional Software (RUO): Simplifies interpretation, highlights errors, and reduces analysis time.

This standardized method allows for high-throughput, reproducible promoter methylation analysis in clinical environments.

Applications in Clinical Diagnostics

This assay is intended for use in clinical laboratories involved in oncology and molecular diagnostics. By detecting MGMT promoter methylation, the test enables:

• Patient stratification for TMZ-based therapies
• Enhanced decision-making for glioblastoma care
• Research into DNA methylation patterns in solid tumors
• Integration into routine diagnostic algorithms

With its CE-IVD certification, the TRUPCR® MGMT Methylation Kit supports compliance in regulated lab settings while offering speed, sensitivity, and interpretability.