IVD China this week: Hitachi, Mindray, BGI, Geneseeq and Sino Biological

Hitachi is localizing most of its production lines in China

On September 28, Hitachi Instruments (Suzhou), Ltd. was approved the certificate for two fully automated sample assistant systems. Hitachi has localized all its product manufactures except for 006 fully automatic biochemical analyzer.

Hitachi Instruments (Suzhou), Ltd. is a wholly-owned enterprise established by Hitachi High-Tech in October 1997 in Suzhou Industrial Park. The company mainly produces Hitachi automatic biochemical analyzer products and parts, electron microscope parts and parts, and cleaning agents for Hitachi biochemical analyzers.

Mindray joined hands with Edwards Lifesciences 

Mindray Medical announced a new milestone in reaching a cooperation agreement with Edwards Lifesciences. This milestone provides a solution that makes Mindray’s BeneVision N-Series the first patient monitoring system to integrate with Edwards FloTracTM sensor for hemodynamic monitoring in the North American market, following their launch in China in 2022.​

BGI’s HPV reagent kit got certified

BGI Genomics announced on October 13 that its wholly-owned subsidiary, BGI Biotechnology (Wuhan) Co., Ltd. has recently certified by NMPA for its human papillomavirus (HPV) typing detection kit (combined with probe anchored polymerization sequencing method).

BGI stated that it is the second approved HPV genotyping test kit based on high-throughput sequencing technology. This kit has been upgraded in terms of detection platform and detection of HPV types, it has the characteristics of high detection sensitivity and flexible flux configuration of multiple sequencing platforms, which can meet the diverse needs of different clinical users.

Geneseeq receives NMPA certificate for its non-small cell lung cancer tissue TMB detection kit

On October 12, NMPA announced the approval of the Breakthrough Medical Device application for Non-Small Cell Lung Cancer Tumor Mutational Burden Test Kit (Reversible terminator sequencing method) produced by Geneseeq Technology.

The product is independently developed and has full intellectual property rights in China, and it is the first next-generation sequencing (NGS)-based TMB test kit approved in China with a large gene panel covering 425 cancer-associated genes. 

Sino Biological officially opened its first bioprocessing center in North America

On October 9, the Sino Biological Center for Bioprocessing (C4B) officially opened at Levit Green in Houston, Texas USA. The opening marks another solid step for Sino Biological in developing its overseas business. This move will also further enhance the company's international reputation and influence.

Headquartered in Beijing, China, Sino Biological is the world’s leading provider of mammalian cell-based recombinant proteins, antibodies, and related contract research services. Referred to as the Center for Bioprocessing (C4B), the new center will specialize in contract research services including custom recombinant protein and recombinant antibody development and manufacture.