DNA methylation biomarkers for early detection of cervical cancer

A biomarker and early detection technology, applied in the field of molecular diagnosis, can solve problems such as hindering disease manifestations, and achieve the effect of specific and sensitive risk assessment

Pending Publication Date: 2021-09-21
HKG EPITHERAPEUTICS LTD
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Problems solved by technology

These epigenetic changes that serve as biomarkers are often produced in abnormal abundance in cancerous tissue and often hamper the manifestation of the disease itself

Method used

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  • DNA methylation biomarkers for early detection of cervical cancer
  • DNA methylation biomarkers for early detection of cervical cancer
  • DNA methylation biomarkers for early detection of cervical cancer

Examples

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example

[0208] The following examples are given for the purpose of illustrating the invention and therefore should not be construed as limiting the scope of the invention.

example 1

[0209] Example 1: Progressive DNA methylation alteration analysis (APDMA) method for determining and obtaining CG position (CGID), the methylation level of CG position is an early predictor of cervical cancer.

[0210] The present invention addresses a major challenge in cervical cancer screening, namely finding robust biomarkers that provide highly accurate and sensitive risk assessments that can guide early intervention and treatment. A general approach is to use case-control logistic regression on genome-wide DNA methylation data to identify loci that are more or less methylated in cancer cells than in controls. However, it is well known that many of the cancers detected by these methods with statistically significant DNA methylation changes are heterogeneous, and many occur late in the development of the cancer and are therefore of very limited value in early detection, which is because they are diluted when the frequency of cancer cells in the specimen is low. Furthermor...

example 2

[0225] Example 2: Discovery of a multigene DNA methylation biomarker set for early detection of cervical cancer.

[0226] The present disclosure further selected 16 CGIDs from the list obtained and disclosed in the first example and Table 1, wherein the 16 CGIDs were hypermethylated between CIN3 and CIN1 and the control, and between CIN3 and the control The highest effect between patients (Cohen D>1.3) and the highest Spearman correlation with CIN stage development r>0.4. (See Table 2 above).

[0227] Next, to obtain the minimum number of CGIDs required to distinguish CIN3 precancerous lesions from control lesions, our method performed penalized regression to reduce the number of CGIDs to five. Then, the method performed multivariate linear regression with these 5 CGIDs as independent variables and CIN3 status as dependent variable. Both CGIDs remained significant (see Table 3 above). A linear regression equation consisting of the weighted methylation levels of these two lo...

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Abstract

The present invention discloses an in vitro method for obtaining DNA methylation biomarkers as exquisite DNA methylation positions in the human genome (i.e., CGIDs) that predict cervical cancer especially at as yet inaccessible early stages by examining progression of "categorical" DNA methylation alterations in three stages of premalignant lesions (cervical intraepithelial neoplasia (CIN)), progressing from CIN1 to CIN3. The present invention discloses combinations of CGIDs for detecting with high specificity and sensitivity cervical cancer by measuring their DNA methylation status and deriving a "methylation score", which is useful as a biomarker for cervical cancer. Also disclosed are kits for predicting cervical cancer using such CGIDs using multiplexed next generation sequencing methylation assays, pyrosequencing assays and methylation specific PCR. The DNA methylation markers (CGIDs) described in the present invention are useful for cervical screening and early detection of cervical cancer by any person skilled in the art to detect cervical cancer.

Description

[0001] Cross References to Related Applications [0002] This application seeks the U.S. Provisional Application Serial titled "DNA METHYLATION MARKERS FOR EARLY DETECTION OF CERVICALCANCER," filed December 4, 2018, under section 119(e) Priority No. 62 / 774,994, the contents of which provisional application is incorporated herein by reference. [0003] sequence list [0004] This application contains a Sequence Listing, which is filed electronically in ASCII format, and is hereby incorporated by reference in its entirety. Said ASCII copy, created on January 12, 2020, is named TPC53811 Seq List_ST25.txt and is 36,864 bytes in size. technical field [0005] The present invention generally relates to DNA methylation signatures in human DNA, particularly in the field of molecular diagnostics. More specifically, the present invention is DNA methylation biomarkers in the form of a panel, individual and combination of polygenic DNA methylation biomarkers for early detection and scr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/6886C12Q1/6858G16B5/00G16B25/20G16B20/30
CPCC12Q1/6886C12Q2600/154G16B20/20
Inventor 莫西·希夫戴维·车世瑞爱德华多·弗朗科玛丽亚姆·埃林
Owner HKG EPITHERAPEUTICS LTD
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