China-based Amoy Diagnostics Co., Ltd (AmoyDx, SHE: 300685) has entered into a partnership with French pharmaceutical company Servier to co-develop a companion diagnostic (CDx) reagent in China. This reagent is designed for detecting mutations in the isocitrate dehydrogenase (IDH) 1 and 2 genes. The product will complement Servier’s vorasidenib, which is a dual inhibitor of mutant IDH1 and IDH2. Vorasidenib is currently awaiting regulatory decisions in the U.S. for the treatment of diffuse gliomas with IDH mutations.
The primary goal of the collaboration is to complete the development, analytical validation, clinical validation, approval, production, and ultimate commercialization of the CDx reagent in the context of clinical trials in mainland China. This will assist in identifying potential patients who may benefit from vorasidenib, selecting patients who will receive the drug treatment, and providing information for the safe and effective use of the medication. AmoyDx will utilize its self-developed NGS Panel to develop CDx reagents for vorasidenib and support its regulatory filing and commercialization in mainland China.- Flcube.com
