CfDNA methylation marker for early detection of head and neck cancer, screening method and detection kit

By screening for differentially methylated regions specific to head and neck cells and combining targeted methylation sequencing and PCR primers, a screening method and detection kit for cfDNA methylation biomarkers for early detection of head and neck cancer have been developed. This method solves the problems of insufficient sensitivity and high invasiveness in existing technologies, and achieves highly sensitive non-invasive detection.

CN122060862APending Publication Date: 2026-05-19SHANGHAI JIAOTONG UNIV
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Patent Information

Application Number
CN202610147781.X
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2026-02-02
Publication Date
2026-05-19

AI Technical Summary

Technical Problem

Existing technologies are insufficient to achieve highly sensitive, specific, and non-invasive detection of early-stage head and neck cancer. Traditional methods are not sensitive enough and rely on operator experience. Puncture biopsy is invasive and carries high risks. cfDNA methylation marker detection technology suffers from problems such as high cost, large data volume, and high false positive rate.

Method used

A set of phenotype-specific differentially methylated regions (DMRs) of head and neck cells were screened and validated. By combining low-starting-amount targeted methylation sequencing with a machine learning model, a screening method and detection kit for cfDNA methylation biomarkers were developed, and detection was performed using bisulfite sequencing and PCR primers.

Benefits of technology

It achieves highly sensitive identification of early-stage head and neck cancer, reduces the high mortality rate of patients, and solves the problems of insufficient sensitivity and large trauma of traditional methods, providing a more accurate and convenient detection method for non-invasive early screening.

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Abstract

The invention discloses a cfDNA methylation marker for early detection of head and neck cancer, a screening method and a detection kit, and relates to the technical field of gene diagnosis and early screening and early detection of cancers. On the basis of large-scale methylation sequencing data, the head and neck cell phenotype specificity differential methylation region (DMR) is screened and verified for the first time, and the detectability of the DMR in the plasma cfDNA of a head and neck cancer patient is defined; high-sensitivity and high-specificity detection of peripheral blood cfDNA is achieved by combining low-initial-quantity (< = 10 ng) targeted methylation sequencing with a machine learning model, the defects that in the prior art, sensitivity is insufficient, tissue traceability is difficult, and trauma is large are overcome, the blank of head and neck cancer cfDNA methylation non-invasive early screening products is filled, and the application prospect is wide. And a foundation is laid for developing sensitive and efficient head and neck cancer early-stage noninvasive detection markers and kits.
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