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AmoyDx, Servier Partner to Develop CDx for Diffuse Glioma in China

NEW YORK – Chinese molecular diagnostic company AmoyDx and pharmaceutical firm Servier announced Wednesday that they have partnered to develop a companion diagnostic test for Servier's investigational drug vorasidenib for use in Chinese patients with diffuse glioma.

The next-generation sequencing-based test will detect isocitrate dehydrogenase (IDH) 1 and 2 gene mutations in patients with diffuse IDH-mutant glioma. Servier's vorasidenib is an investigational dual inhibitor of mutant IDH1 and mutant IDH2 enzymes, the companies noted in a statement.

The companies plan to develop, analytically and clinically validate, manufacture, and commercialize the test for use in Chinese clinical trials to identify potential responders and select patients to be treated with vorasidenib. AmoyDx will use its NGS panel to develop the test and to guarantee the registration and commercial availability in China once vorasidenib receives regulatory approval, the companies said.

In addition to being assessed by Chinese regulators, vorasidenib is being evaluated by the US Food and Drug Administration, the European Commission, and Orbis member countries such as Brazil, Canada, Australia, Israel, and Switzerland. A Chinese regulatory decision is expected by 2030, the companies added.

Servier has also inked deals with companies in the US, Europe, and Japan to develop companion diagnostic tests for vorasidenib.

"As an innovative player in the field of IDH-mutated tumors, we are fully convinced that early detection of IDH 1 and 2 mutations play a critical role in the treatment of patients suffering from diffuse glioma," Servier Global Head of Translational Medicine Fabien Schmidlin said in a statement. "The development of a therapy and the associated companion diagnostic test are two parallel highways that are connected to each other providing the right patient with the right treatment faster."