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Methylation Standard


Background

With the development of biomedicine, the importance of DNA methylation markers in cancer diagnosis, treatment selection and prognosis assessment has become increasingly prominent.
    In the field of modern tumor treatment, tumor DNA methylation markers, as an important biomarker, play an increasingly critical role in the early diagnosis, treatment selection and prognosis assessment of cancer.

Methylation Enterprise Reference/Quality Control Products

    CB-Gene can provide IVD companies with relevant raw materials and personalized customization services for methylation enterprise reference products to safeguard the development of test kits. At the same time, we can also provide relevant quality control products to ensure the accuracy of testing.

 

1.Single Gene Single Segment

 

Screening: hotspot gene-methylation island-large segment-small segment-accurate quantification; through the "five-step method", from accurate anchoring of methylated genes to accurate quantification of precise sites, the degree of methylation is accurately quantified by digital PCR. For example: quality control products for a specific segment of the MGMT gene and strong positive, weak positive, detection limit, precision, and negative reference product plates.
 

2.Single Gene Multi-segment 


Since there are multiple small segments, it is difficult to design probes for some preferred segments, and multiple segments can improve detection specificity. Through the "five-step method", multiple clinically significant segments of a single gene are found. For example: quality control products for PTGER4 single gene double segments and strong positive, weak positive, detection limit, precision, and negative reference product plates.
 

3.Multi-gene Reference Plate 


Generally, for a single indication, multiple genes (such as 2-5), multiple segments, multiple PCR is carried out to improve the specificity of the test. For example: lung cancer-SHOX2, PTGER4, RASSF1A, including triple positive, triple negative, single positive and other quality control products, as well as strong positive, weak positive, detection limit, precision, and negative reference product plates.


There are dozens of genes, tens of thousands of segments, no specific direction, including zero methylation, 100% full methylation, low methylation, medium methylation, and high methylation. For example, the zero methylation standard is WGA whole genome amplification, the average methylation level is 0, and it is double-verified by ddPCR and enzyme digestion.
 

4.Cancer-Sample-Package 


When the specific gene segment is not determined and screening is required, we divide it by cancer indication and provide tumor samples and healthy human samples of various cancer types, such as liver cancer sample package and cervical cancer sample package.


Dozens of genes, tens of thousands of segments, no specific direction, including zero methylation, 100% full methylation, low methylation, medium methylation, high methylation. For example, the zero methylation standard is WGA whole genome amplification, the average methylation level is 0, and the ddPCR method and enzyme digestion method are used for double verification.




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