Solid Tumor Multi-gene Combined Detection Kit ( Reversible Terminator Sequencing)   

Primary DI

06974968583179

Basic UDI-DI Code

B-06974968583179

Reference

L000044

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

GeneMind Biosciences Co., Ltd.

Cancer is a complex polygenic disease, which is caused by the gradual accumulation of gene mutations. When the genes regulating cell growth are mutated or damaged, the cells lose control and proliferate indefinitely, leading to the emergence of malignant tumors. Tumor individualized diagnosis and treatment can accurately judge the unique gene mutation information of each solid tumor patient, and provide important reference information for the use of targeted drugs, immunotherapy, chemotherapy drugs, genetic risk, prognosis, and recurrence monitoring. Microsatellite Instability (MSI) refers to the length change of microsatellite (MS) sequence caused by insertion or deletion mutations during DNA replication, which is often caused by mismatch repair (MMR) defects. MS sequences are short and repetitive DNA sequences, which are generally composed of 1-6 nucleotides and arranged in tandem repeats. The common types are dinucleotide repeats of CA/GA/GT or mononucleotide repeats of A/T. MS sequences can be located in the important non-coding region or coding region of genes. Polymorphisms are distributed in the whole genome, with great individual differences. MSI is present in colorectal cancer, endometrial cancer, gastric cancer, hepatocellular carcinoma, breast cancer, and other solid tumors. In clinical application, it can be used for the screening of Lynch syndrome (also known as hereditary non polyposis colorectal cancer (HNPCC)), and the prognosis and medication guide of colorectal cancer. Tumor mutation burden (TMB) generally refers to the number of nonsynonymous mutations in somatic cells in a specific genomic region, which can indirectly reflect the ability and degree of tumors to produce neoantigens. It has been proved that TMB can predict the efficacy of immunotherapy for many kinds of tumors. Tissue TMB can be used as an independent biomarker to predict the efficacy of immunotherapy.

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