Eu Ivdd Eu Ivd General On The Market 🇨🇳 China

BRCA1 and BRCA2 Gene Mutation Detection Kit ( Reversible Terminator Sequencing)    

GeneMind Biosciences Co., Ltd. · 🇨🇳 China
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
06974968583162
Basic UDI-DI Code
B-06974968583162
Reference
L000043
Device Types
None provided
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market

Additional Description

BRCA1 and BRCA2 genes are tumor suppressor genes involved in DNA damage repair and transcriptional regulation. Studies have shown that the sensitivity of tumor cells with BRCA1/2 gene mutations to PARP inhibitors is significantly higher than that of normal cells. Inhibiting the activity of PARP-1 can lead to synthetic lethality in tumor cells with BRCA1/2 gene mutations. Poly ADP-ribose polymerase 1 (PARP-1) plays an important role in DNA damage repair and apoptosis. Tumor cells with BRCA1 and BRCA2 gene mutations often rely on PARP-1 to complete the repair of DNA damage. Therefore, PARP inhibitors can targetedly kill tumor cells with BRCA1/2 gene mutations by inhibiting the function of PARP-1. Clinical studies have shown that ovarian or breast cancer patients with BRCA1 or BRCA2 gene mutations can benefit from the treatment of PARP inhibitors such as Olaparib and Rubraca.

CND Nomenclature Codes

Code Description
W01060203 BRCA 1+2

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