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Application of SEPT9 mRNA in exosome in diagnosis of breast cancer

An exosome and breast cancer technology, applied in the field of biomedical diagnosis, can solve the problems of reducing the positive rate of patients, inapplicable to clinical disease diagnosis, and high positive missed detection rate, avoiding excessive tissue biopsy, solving breast malignant nodules, Ease of clinical promotion

Inactive Publication Date: 2021-04-20
JIANGSU MICRODIAG BIOMEDICINE TECH CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, the breasts of Chinese women are small and dense, which will also reduce the positive rate of patients receiving mammography
[0007] 3. Early detection of biological targets: including general screening of breast cancer-related genes, such as BRCA1 and BRCA2 mutation analysis, but current molecular diagnosis research mostly focuses on the relationship between gene polymorphisms and breast cancer, which can only give the susceptibility risk of patients, not Applicable to the diagnosis of clinical diseases
In addition, the most commonly used serum tumor markers for breast cancer in clinical practice include CA-153, CEA, CA-125, etc. Although they can reflect the state of the disease to a certain extent, the specificity is not high. In many other tumors, such as ovarian cancer, Pelvic tumors, gastric cancer, colon cancer, liver cancer, etc. will exist accordingly
It is reported that the sensitivity of CA-153 is only about 50%, and the expression level in early breast cancer patients is often low, and the specificity is not high, which has certain limitations in the early screening of breast cancer
[0008] 4. Needle biopsy: The pathological examination of breast tissue needle biopsy has high accuracy, but it is an invasive operation, and false negative results may be produced due to insufficient specimen collection, or due to different sampling sites, intratumoral abnormalities in breast cancer, etc. Qualitative effects can produce different results
[0009] In general: the screening of breast nodules has the following deficiencies: (1) the cost of clinical physical examination is high; (2) the rate of positive and missed detection of imaging diagnostic methods is high; (3) the current relatively mature biological targets, only Can do risk assessment, not suitable for clinical diagnosis; (4) Puncture biopsy is firstly invasive, in addition, it has high requirements for the sampler and puncture site, and it is easy to cause different results due to the influence of external factors

Method used

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  • Application of SEPT9 mRNA in exosome in diagnosis of breast cancer
  • Application of SEPT9 mRNA in exosome in diagnosis of breast cancer
  • Application of SEPT9 mRNA in exosome in diagnosis of breast cancer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0135] In the following examples, it is analyzed by SEPT9 mRNA assay, which is designed to run on a fluorescent quantitative PCR detection platform to verify the differential performance of marker mRNA expression in benign breast nodules and breast malignant nodules, so as to provide markers An indication of precision for differentiating patients with benign breast nodules from malignant breast nodules.

[0136] Using the Lightcycle480 platform to analyze the performance of markers, the marker is SEPT9:

[0137] The experimental method is as follows:

[0138] 1. Plasma Processing:

[0139] Whole blood was collected using EDTA anticoagulant tubes, and plasma was obtained by centrifugation within 2 hours at room temperature. Centrifugation conditions: 1500g, 10 minutes, absorb the supernatant, centrifuge again: 15000g, centrifuge for 10 minutes, absorb the supernatant, which is the separated plasma.

[0140] 2. Exosome identification:

[0141] 2mL of plasma was filtered with a...

Embodiment 2

[0154] In the following examples, it is analyzed by SEPT9 mRNA assay, which is designed to run on a fluorescent quantitative PCR detection platform to verify the expression of markers in different samples and evaluate its breast cancer detection performance.

[0155] In this example, 31 cases of plasma samples were enrolled, including 17 cases of breast malignant nodule samples, specifically 9 cases of ductal carcinoma in situ with microinvasion, 5 cases of ductal carcinoma in situ, and 3 cases of lobular carcinoma in situ; 14 cases of breast cancer Benign nodules, specifically 10 cases of fibroadenoma, 3 cases of papilloma, and 1 case of ductal epithelial hyperplasia. Detect SEPT9 mRNA in exosomes, and investigate the target's ability to distinguish benign from malignant breast nodules.

[0156] See Example 1 for plasma exosome extraction, RNA extraction and detection. The test results are shown in Table 3.

[0157] Table 3: Differentiation between benign and malignant brea...

Embodiment 3

[0162] The test sample type in this embodiment is: plasma, and a total of 91 samples were enrolled. Among them, 37 cases of breast cancer: 3 cases of intermediate-grade ductal carcinoma in situ, 5 cases of high-grade ductal carcinoma in situ, 17 cases of invasive ductal carcinoma, 3 cases of lobular carcinoma in situ, and 9 cases of invasive lobular carcinoma; 54 cases of non-breast cancer: 13 cases of lung cancer, 10 cases of colorectal cancer, 13 cases of benign breast disease (7 cases of mastitis, 4 cases of papilloma, 2 cases of ductal epithelial hyperplasia) and 18 cases of healthy subjects.

[0163] See Example 1 for plasma exosome extraction, RNA extraction and detection. The test results are shown in Table 4.

[0164] Table 4: Auxiliary diagnosis of breast cancer

[0165]

[0166]

[0167]

[0168]

[0169] Results: 37 cases of breast cancer, 34 cases were positive, the sensitivity was: 91.89%; 54 cases of non-breast cancer, 41 cases were negative, the sp...

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Abstract

The invention relates to the field of biomedical diagnosis, in particular to application of SEPT9m RNA in exosome in diagnosis of breast cancer. The SEPT9 mRNA in exosome can be used to screen and identify patients with suspected lesions, and can solve the problem that early malignant breast nodules cannot be confirmed by imaging, and it is the first time to find that the exosome SEPT9 mRNA marker can be used for identifying benign and malignant human exosome breast nodules.

Description

technical field [0001] The present invention relates to the field of biomedical diagnosis, in particular to the application of SEPT9 mRNA in exosomes in the identification of benign and malignant breast nodules, auxiliary diagnosis of breast cancer, and disease course monitoring. Background technique [0002] Breast cancer is one of the most common malignant tumors in women, and its incidence rate ranks first among female malignant tumors. It has become the main cause of threats to women's health. Its incidence is often related to heredity, and between the ages of 40 and 60, the incidence rate of women before and after menopause is higher. It is one of the most common malignant tumors that usually occurs in the glandular epithelial tissue of the breast, seriously affecting women's physical and mental health and even threatening their lives. Breast cancer is rare in men, and only about 1-2% of breast cancer patients are men. [0003] In recent years, the incidence of breast...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/6883C12Q1/6886
Inventor 巴兆粉丁凤英韩春苗王弢
Owner JIANGSU MICRODIAG BIOMEDICINE TECH CO LTD
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