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7 Chinese IVD Companies Got ST2 Authorization

2021/10/8 17:43:14 Views:135



A new generation of heart failure management marker ST2 (growth STimulation expressed gene 2)has received more and more attention in recent years. For more than ten years before -ST2 has been considered as an orphan receptor. Until 2005, scientists proved that IL-33 is the ligand of ST2 through experiments such as immune-coprecipitation. Subsequent studies on il-33-st2 signaling pathway in various diseases showed that the expression of soluble ST2 (ST2) and cross model ST2 (ST2L) of two isomers were up-regulated. ST2 could be used as a decoy receptor to neutralize the cardioprotective mechanism of IL-33 / ST2L. The clinical role of ST2 has also been more explored. More and more clinical data studies have confirmed the application value of ST2 as a marker of heart failure.


In 2002, Brigham Women's Hospital issued the intellectual property rights related to ST2. In 2004, critical diagnostics was established and has the global exclusive right to ST2 intellectual property rights. Since then, the company has expanded its intellectual property portfolio and holds several patents issued in the United States, China and other countries, as well as other patents under application. In 2011, the company applied for invention patents represented by application No. 201180026646.5 in China. On March 24, 2015, CFDA (Now NMPA) announced the approval of presage ST2 for clinical use.


On Sep. 29, 2021, ET Healthcare announced that it was granted the ST2 patent of Critical Care Diagnostics, Inc. (CCD). So far, many Chinese companies have been legally authorized to manufacture and / or sell ST2 reagent products as follows:



COMPANY NAME

Shanghai Ever Best Biotech Co., Ltd.

Shanghai Maike Biotech Co., Ltd.

Beijing Leadman Biochemistry Co., Ltd.

SHANGHAI UPPER BIO-TECH CO., LTD.

Micropoint Biotechnologies Co., Ltd.

Boditech(Guangxi)Biotechnology Co., Ltd.

Goldstandard Diagnostics Inc.



In addition to the clinical application of risk stratification, adjuvant therapy, health and prognosis judgment for patients with heart failure, ST2 has the advantage of not being affected by factors such as age, body mass index or renal function, which makes it a shining star of clinical markers of heart failure after linapeptide family and favored by more clinicians all over the world.