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Method and kit for guiding epirubicin individualized medication gene

A technology of epirubicin and a kit, which is applied in the field of guidance method and kit of epirubicin individualized medicine gene

Pending Publication Date: 2021-04-23
广东南芯医疗科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Since the 1970s, the application of chemotherapy for breast cancer has greatly improved the therapeutic effect of breast cancer, but chemotherapy is a double-edged sword, and the adverse reactions caused by chemotherapy are important factors that limit the application of chemotherapy
At present, there is no very effective guidance method for epirubicin in clinical practice, so it is urgent to establish a highly sensitive, economical and simple molecular technology screening method to fill the gap in China

Method used

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  • Method and kit for guiding epirubicin individualized medication gene
  • Method and kit for guiding epirubicin individualized medication gene
  • Method and kit for guiding epirubicin individualized medication gene

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0085] Feasibility analysis of SNP site screening of human epirubicin individualized drug-related genes

[0086] By searching NCBI home and abroad genome-wide association study (genome-wide association study, GWAS) in the large-scale pathological control group clinical research of epirubicin drug safety and efficacy-related loci, the inventors made After screening and evaluation, 5 single nucleotide polymorphism sites significantly related to epirubicin individualized medication were selected, and independent of each other, there was no linkage disequilibrium, so the site selection of the present invention is representative , independence and risk value accumulation, which can be used to guide the individualized medication of epirubicin.

[0087] The screened SNP sites are as follows:

[0088] rs7668258, rs915927, rs2854501, rs1143684, rs2279744.

Embodiment 2

[0089] Embodiment 2 system verification

[0090] System validation includes accuracy, specificity, sensitivity, precision, and comparison among personnel.

[0091] Accuracy verification scheme: 20 cases were detected at each site, compared with Sanger sequencing, the expected target was 95%.

[0092] Specificity Validation Protocol: Included in Accuracy, expected target 95%.

[0093] Sensitive verification scheme: using human genomic DNA positive samples as templates, the DNA contents of calibration samples were 1ng / μL, 5ng / μL, 10ng / μL, 50ng / μL, and 100ng / μL for sensitivity inspection.

[0094] The precision verification plan (including intra-batch, inter-batch, and personnel comparisons, not involving inter-instrument comparisons) has an expected target of 95%.

[0095] Intra-assay precision: The same batch of each sample was repeated 3 times to compare the intra-assay precision.

[0096] Inter-batch precision: The same operator tests the same sample in multiple batches to...

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Abstract

The invention provides a method and kit for guiding an epirubicin individualized medication gene, and particularly relates to a method for screening out a combination of SNP loci of genes related to epirubicin individualized medication by considering the difference of medication curative effects of different cancer patients. A nucleic acid mass spectrometer is used for widely screening and inspecting epirubicin-related genetic markers (high-throughput detection sites and high-throughput detection samples). The method disclosed by the invention is high in detection success rate, good in technical reproducibility and high in cost performance, can realize detection of multiple genes of a single small sample, and meets maximized use of the small sample; and the method provided by the invention has the technical advantages of high accuracy and high sensitivity, the detection result is stable, and the detection positive rate is improved.

Description

technical field [0001] The invention belongs to the field of biotechnology, in particular, the invention relates to a gene guiding method and kit for epirubicin individualized medicine. Background technique [0002] Epirubicin (Famasin) has 14 indications approved by CFDA, which can treat malignant lymphoma, breast cancer, lung cancer, soft tissue sarcoma, esophageal cancer, gastric cancer, liver cancer, pancreatic cancer, melanoma, colon cancer Rectal cancer, ovarian cancer, multiple myeloma, leukemia, and superficial bladder cancer (partial perfusion of the bladder). Large clinical studies have been conducted in the above approved indications and provided data on efficacy and safety. Due to the common side effects and cardiotoxicity of anthracyclines, their clinical application is often limited, but they can be managed. Before treatment, fully evaluate the benefits and potential risks of treatment, and fully understand the patient's organ function and tumor conditions. C...

Claims

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Application Information

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IPC IPC(8): C12Q1/6886C12Q1/6858C12N15/11
CPCC12Q1/6858C12Q1/6886C12Q2600/106C12Q2600/156C12Q2600/16C12Q2531/113C12Q2537/143C12Q2521/525C12Q2533/101C12Q2565/627
Inventor 陈涛张静袁昕昕林金飞
Owner 广东南芯医疗科技有限公司
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