DNA methylation detection standards - Helping Tumor Methylation Research

Background

Gene methylation detection products are one of the hottest tracks in the IVD field. Compared with many mature IVD detection kits, methylation detection products have huge potential in the field of tumor auxiliary diagnosis/screening. Moreover, compared with the red ocean of the mature IVD detection kit market, although the development of methylation IVD kits is also very competitive, there are many opportunities, such as overtaking on the curve and becoming a dark horse in the industry.

Currently, there are 20 methylation IVD detection kits certified in China.

At the same time, there are also many products entering the clinical trial stage. According to the data analysis from 2021 to the first quarter of 2023 released by Youzikang, there are already 58 products entering the clinical trial stage.

Methylation Standards

As a company specializing in the development of molecular diagnostic standard products, CB- Gene has gradually become the preferred supplier for domestic and foreign IVD test kit manufacturers and developers during the company's 10 years of continuous development. In the course of development over the years, we have kept pace with the times and launched one popular standard product after another, such as small panels for lung cancer, large panels for pan-tumor, tTMB/bTMB, MSI, HRR/HRD, MRD, etc. Naturally, in 2023, we will also assist in the development of methylation standards (quality control products and reference products) to meet the needs of domestic and foreign industry customers.

Based on the fact that methylation has a clear prospect in the early detection and screening of tumors, CB- GeneBio also chooses tumor-related gene methylation as the research object. Some genes are shown in the following table:

Table 1 ：Some genes related to tumors are shown, red ones are relatively hot genes

Development ideas

CB-Gene will continue to develop corresponding standards for the above genes. The development ideas are mainly divided into 4 steps:

1. According to the gene sequence, find the key CGI, combine the structure of the gene transcript, and the relationship with TSS to preliminarily screen out the key CGI;

2. Establish an internal primary screening system, combine the selected CGI segment, select amplicons within a certain range, and use common methylation detection methods (such as BSP and pyrophosphate sequencing) to detect the methylation data of multiple amplicons in the target area;

3. According to the data in the second step, carefully judge the useful small amplicon area, develop dPCR in this area, and detect the methylation degree of the CG;

4. Based on the methylation data of this area and this site, establish a full set of reference and quality control products.