Product Description

The MGMT (O⁶-methylguanine-DNA methyltransferase) gene is located on human chromosome 10 (10q26). The MGMT protein it encodes is an important DNA repair enzyme. Its core function is to repair DNA damage caused by alkylating agents (such as the chemotherapy drugs temozolomide and carmustine) by transferring the alkyl group from O⁶-alkylguanine (such as O⁶-methylguanine) to its own cysteine residues. This process irreversibly inactivates the MGMT protein, leading to its frequent nickname as a "suicide enzyme."

The promoter region of the MGMT gene contains a region rich in CpG sites (CpG islands). When these CpG sites become methylated (i.e., methyl groups are added to the DNA molecule), it typically alters chromatin structure, preventing transcription factors from binding to the promoter, leading to gene silencing (transcriptional arrest) and loss of MGMT protein expression. Therefore, MGMT promoter methylation in tumor cells indicates a reduced ability to repair DNA alkylation damage.

MGMT methylation standards are genomic DNA (gDNA) samples with known MGMT gene promoter methylation levels that have been rigorously assayed and quality-controlled. These standards are typically derived from specifically treated cell lines and exhibit high stability and homogeneity, ensuring reliable, accurate, and reproducible experimental results.

General information

Name	MGMT methylation single gene single segment standard
Cat. No.	CBPE0250-0256
Format	Genomic DNA
Size	1ug
Buffer	Tris-EDTA
Intended Use	Research Use Only
Concentration	Download for COA
Purity	Download for COA
DNA electrophoresis	Download for COA
Storage Conditions	2~8℃
Expiry	36 months from the date of manufacture
Remark	The data in the instruction manual is the data of a single test, and the specific data of each batch is subject to delivery.

Technical Data

Classification		Cat No.	Name	Unit Size	Methylation level
Classification		Cat No.	Name	Unit Size	Chr10:131265516-131265596(hg19)
quality control standard	Positive quality control	CBPE0250	MGMT Methylation Positive control	1ug	98.30%
quality control standard	Negative quality control	CBPE0251	MGMT Methylation Negative control (< Cut off)	1ug	0.00%
Reference Standard	High positive reference-1	CBPE0252	MGMT Methylation Reference Standard with > 90%	1ug	98.30%
	High positive reference-2	CBPE0253	MGMT Methylation Reference Standard with 10%	1ug	10.92%
	Low positive reference	CBPE0254	MGMT Methylation Reference Standard with 3%	1ug	3.10%
	LOD reference	CBPE0255	MGMT Methylation Reference Standard with 1%	1ug	1.10%
	Negative reference	CBPE0256	MGMT Methylation Negative Reference Standard (< Cut off)	1ug	0.00%
	Precision reference	CBPE0254	MGMT Methylation Reference Standard with 3%	1ug	3.10%
	Precision reference	CBPE0256	MGMT Methylation Negative Reference Standard (< Cut off)	1ug	0.00%
	Specificity reference	Customization
Remark	1. Quality control products are also called accuracy standards, which are used for qualitative judgment; 2. Reference products are used for qualitative and quantitative judgments, among which the judgment of strong positive, weak positive, detection limit, precision, and specificity depends on the specific project. The judgment of this product is only an internal standard; 3. Quality control products are used for performance evaluation, factory inspection, and routine testing and judgment of test kits, and reference products are used for performance evaluation and factory inspection; 4.The above products only show part of the results, and the degree of methylation can be customized.
Remark

Application Scenarios

MGMT methylation status testing and its standards play an indispensable role in multiple key scenarios.

1. Cancer Research and Basic Molecular Biology Research

·Exploring methylation mechanisms: Studying the specific mechanisms of MGMT gene promoter methylation in tumor development, progression, metastasis, and treatment resistance.

·Developing New Detection Methods: When developing new MGMT methylation detection kits or technologies, standards are key raw materials used to establish the detection system, optimize reaction conditions, and validate method performance indicators (such as specificity, sensitivity, and reproducibility).

2.Clinical Diagnosis and Personalized Treatment

This is the most important application area for MGMT methylation testing, particularly in gliomas.

·Predicting Chemotherapy Sensitivity and Guiding Clinical Drug Use:

Glioblastoma (GBM): MGMT promoter methylation status is one of the most important predictive biomarkers. The NCCN Clinical Practice Guidelines for Central Nervous System Tumors in the United States clearly state that GBM patients should undergo MGMT gene methylation testing to assess response to temozolomide (TMZ) chemotherapy.

Other Tumors: MGMT methylation is also common (25%-50%) in colorectal cancer, lung cancer, lymphoma, breast cancer, and other tumors, and its clinical significance is still under investigation.

·Prognostic Assessment:Numerous studies have confirmed that glioma patients with MGMT promoter methylation are often more sensitive to temozolomide chemotherapy, resulting in longer progression-free and overall survival, and a relatively better prognosis.

3.Quality Control in Clinical Testing Laboratories

·In-House Quality Control (IQC): In routine testing, positive and negative standards are tested simultaneously with each batch or daily experiment to monitor the reliability of the experimental process and the accuracy of the results, effectively preventing false positives and false negatives.

·External Quality Assessment (EQA): Authoritative institutions (such as clinical testing centers) distribute methylation standards of unknown concentration to various laboratories for testing. This allows for the evaluation and comparison of the consistency and accuracy of test results from different laboratories, and is an important foundation for achieving interlaboratory recognition of test results.

4.Drug Development and Companion Diagnostics

·When developing new alkylating agents or combination therapy regimens, MGMT methylation standards are needed to screen for patients who may benefit from the drugs, thus facilitating precision medicine clinical trials.

·When developing companion diagnostic (CDx) kits for specific drugs, standards are essential tools for validating kit performance.