Orient Gene's Liquid Biochip Breakthrough with Obtaining First Domestic Registration Certificate

On the evening of July 12, Zhejiang Orient Gene Biotech Co., Ltd announced that its wholly owned subsidiary, Shanghai Wanzi Health Medical Laboratory Co., Ltd., had obtained medical device registration certificates for carcinoembryonic antigen, neuron-specific enolase, and cytokeratin 19 fragment detection kit (flow fluorescence luminescence method).

According to the announcement, the product is expected to be used for in vitro quantitative detection of carcinoembryonic antigen (CEA), neuron-specific enolase (NSE), and cytokeratin 19 fragment (CYFRA21-1) in human serum, and it is mainly used for dynamic monitoring of patients with malignant tumors to assist in determining the progress of the disease or the effect of treatment.

Liquid biochip is one of the key industries developed by Orient Gene in recent years. In this field, Orient Gene has made a systematic layout from raw materials to reagents to instruments and owns all independent intellectual property rights.

At present, its liquid biochip is about to usher in the harvest period, part of the series of products has been filed in the European Union, the domestic registration process is also in progress, the approved product is the first series of products to obtain the domestic registration certificate.

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