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Biomarkers and detection kits for prostate cancer diagnostic grading and benign and malignant prediction

A technology of biomarkers and diagnostic kits, which is applied in the fields of biotechnology and medicine, can solve problems such as general specificity, specificity and sensitivity are not very ideal, achieve broad application prospects, save manpower and material costs, and improve clinical The effect of applying value

Active Publication Date: 2022-05-10
北京恩泽康泰生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The urine-based prostate cancer antigen 3 (PCA3) gene test (Progensa PCA3, Hologic Inc., Marlborough, MA, USA) was approved by the US Food and Drug Administration (FDA) in 2012 for the diagnosis of prostate cancer, but specific The sensitivity and sensitivity are not very ideal; Bio-Techne's ExoDx Prostate IntelliScore product has passed the FDA's breakthrough medical device certification this year. Products in zone 2-10ng / ml whether patients are at risk of prostate cancer have moderate specificity despite high sensitivity

Method used

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  • Biomarkers and detection kits for prostate cancer diagnostic grading and benign and malignant prediction
  • Biomarkers and detection kits for prostate cancer diagnostic grading and benign and malignant prediction
  • Biomarkers and detection kits for prostate cancer diagnostic grading and benign and malignant prediction

Examples

Experimental program
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Effect test

Embodiment 1

[0104] Example 1 Separation of Urine Exosomes

[0105] 1. UC method: 40ml human morning urine sample, centrifuged at low speed to remove cells, centrifuged at 17000g for 30min to remove cell debris and apoptotic bodies, etc., ultracentrifuged at 100000g for 2h, removed supernatant, resuspended in PBS and centrifuged again at 100000g for 2h, resuspended in 100ul PBS Exosomes were obtained by suspension pellet.

[0106] 2. Ultrafiltration method: After the sample is thawed, centrifuge at 17000xg for 30min; after centrifugation, the sample passes through 0.45um and 0.22um in turn; prepare two ultrafiltration centrifuge tubes, and take 15ml of the sample filtered by the filter membrane in each ultracentrifuge tube, 4500xg at room temperature Centrifuge for 15 minutes; carefully take out the centrifuge tube, discard the liquid at the bottom of the ultrafiltration tube, then resuspend the retentate with 5ml of the remaining filtered urine and 10ml of 1XPBS, invert 3-4 times to mix t...

Embodiment 2

[0111] Example 2 Screening of differentially expressed genes

[0112] In order to screen the urinary exosome markers related to prostate cancer patients (including PSA>20ng / ml and 4-20ng / ml prostate cancer patients) and controls (normal people and interfering samples such as prostatitis and prostatic hypertrophy) In 20 cases, no less than 30ml of morning urine was taken, and the exosomes in the urine were separated by classical ultracentrifugation method and RNA was extracted. The obtained RNA was subjected to miRNA and long RNA library sequencing (including mRNA, LncRNA and CircRNA). The obtained data was analyzed by bioinformatics, and the differentially expressed RNAs in prostate cancer patients and controls were compared, and the genes with differential expression folds of more than 4 times were selected and miRNA sequencing and transcriptome sequencing data organized in the TCGA (The Cancer Genome Atlas) database Correlation analysis was carried out to obtain differential...

Embodiment 3

[0115] Example 3 Validation of selected gene markers by real-time fluorescent PCR

[0116] 1. Design and synthesis of primer probes

[0117] Primer Premier 5 software and Primer-BLAST (NCBI) were used to design primers and probes for 8 prostate cancer markers listed in Table 1 and 3 internal reference genes, and the sequences are shown in Table 2. The design principles are as follows: 1) the amplified fragment is less than 150bp; 2) at least one primer spans the exon-exon boundary; 3) the Tm value of the probe is at least 5 degrees higher than that of the primer. After the design is completed, it will be handed over to a qualified company for synthesis, in which the 5' end of the probe is labeled with the FAM group, and the 3' end is labeled with BHQ1.

[0118] Table 2 Prostate cancer markers of the present invention and primer probe sequences of internal reference genes

[0119]

[0120]

[0121] *marked as internal reference genes.

[0122] 2. Reverse transcription ...

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Abstract

The invention provides a biomarker and a detection kit for the diagnosis and grading of prostate cancer and the prediction of benign and malignant. The biomarker is at least one of AMACR, PCA3, ACSM1, SPON2, PCAT14, OR51E2, ERG and RPL7P16 genes. The kit of the present invention can diagnose prostate cancer, the diagnostic model performance AUC reaches 0.75, the sensitivity and NPV are 0.97 and 0.94, and the AUC combined with tPSA diagnosis reaches 0.84; when distinguishing the grade of prostate cancer, the AUC is 0.79, the sensitivity and NPV are 0.93 and 0.91, combined with tPSA The diagnostic AUC is 0.85; when used to diagnose benign and malignant PSA samples, the AUC is 0.8, and the sensitivity and NPV are 0.9 and 0.96. The detection sample of the kit of the invention can avoid the pain and possible infection caused by the puncture detection of patients, and has good clinical application value.

Description

technical field [0001] The invention relates to the fields of biotechnology and medical technology, in particular to a biomarker and a detection kit for grading prostate cancer and predicting benign and malignant. Background technique [0002] Prostate cancer is one of the common malignant tumors of the urinary system. Its incidence rate ranks second among males worldwide, and its mortality rate ranks fifth. The report shows that in 2012, the incidence rate of prostate cancer in my country's tumor registration areas was 9.92 / 100,000, ranking sixth in the incidence rate of male malignant tumors. With the change of lifestyle and population aging, the morbidity and mortality of prostate cancer in my country are increasing year by year, and its growth rate has leapt to the first among men. The incidence of prostate cancer also has obvious differences in different regions, ages and races. In addition, family history, eating habits, obesity, smoking, occupational exposure, prost...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C12Q1/6886C12N15/11C12Q1/6851
CPCC12Q1/6886C12Q1/6851C12Q2600/166C12Q2600/112C12Q2600/118C12Q2600/158C12Q2563/107C12Q2561/113C12Q2531/113
Inventor 孔关义陈苏红秦宏亮陈亚庆刘翔赵立波
Owner 北京恩泽康泰生物科技有限公司
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