Lung Cancer Circulating Tumor DNA Multi-gene Mutation Combined Detection Kit ( Reversible Terminator Sequencing) 

Primary DI

06974968583209

Basic UDI-DI Code

B-06974968583209

Reference

L000046

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

GeneMind Biosciences Co., Ltd.

Lung cancer is the most common primary malignant tumor of the lungs and one of the most common malignant tumors in China. NSCLC accounts for approximately 85% of all cases of lung cancer. While small cell lung cancer (SCLC) accounts for less than 15%. NSCLC is a highly heterogeneous tumor with multiple molecular subtypes. Common driver genes of it include ALK, BRAF, EGFR, ERBB2(HER2), FGFR3, KRAS, MAP2K1, MET, NTRK1, PIK3CA, RET, ROS1, NRASE, etc. After years of development, a variety of targeted drugs have been approved for marketing, including EGFR tyrosine kinase inhibitors (TKI), such as gefitinib, erlotinib, ektinib, afatinib, and oshitinib; ALK inhibitors such as crizotinib, ceritinib, and alectinib; ROS1 inhibitor crizotinib; BRAF inhibitor dabrafenib and MEK inhibitor trametinib. At the same time, there are many other targeted drugs in clinical trials. Therefore, with the development of targeted drugs, molecular companion diagnostics that cooperate with them have become indispensable.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).